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Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04894864
Recruitment Status : Recruiting
First Posted : May 20, 2021
Last Update Posted : November 1, 2021
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by (Responsible Party):
George Papastratigakis, MD, University of Crete

Tracking Information
First Submitted Date  ICMJE April 19, 2021
First Posted Date  ICMJE May 20, 2021
Last Update Posted Date November 1, 2021
Actual Study Start Date  ICMJE October 8, 2020
Estimated Primary Completion Date October 8, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2021)
  • Surgical Stress Response - IL-6 - Preoperatively [ Time Frame: 1) Preoperatively (as a baseline) ]
    Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-6 - 15 minutes after aortic cross-clamp [ Time Frame: 2) 15 minutes after aortic cross-clamping ]
    Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-6 - 60 minutes after aortic cross-clamp [ Time Frame: 3) 60 minutes after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-6 - 24 hours after aortic cross-clamp release [ Time Frame: 4) 24 hours after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-8 - Preoperatively [ Time Frame: 1) Preoperatively (as a baseline) ]
    Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-8 - 15 minutes after aortic cross-clamp [ Time Frame: 2) 15 minutes after aortic cross-clamping ]
    Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-8 - 60 minutes after aortic cross-clamp [ Time Frame: 3) 60 minutes after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-8 - 24 hours after aortic cross-clamp release [ Time Frame: 4) 24 hours after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-10 - Preoperatively [ Time Frame: 1) Preoperatively (as a baseline) ]
    Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-10 - 15 minutes after aortic cross-clamp [ Time Frame: 2) 15 minutes after aortic cross-clamping ]
    Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-10 - 60 minutes after aortic cross-clamp [ Time Frame: 3) 60 minutes after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-10 - 24 hours after aortic cross-clamp release [ Time Frame: 4) 24 hours after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - AVP - Preoperatively [ Time Frame: 1) Preoperatively (as a baseline) ]
    Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - AVP - 15 minutes after aortic cross-clamp [ Time Frame: 2) 15 minutes after aortic cross-clamping ]
    Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - AVP - 60 minutes after aortic cross-clamp [ Time Frame: 3) 60 minutes after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - AVP - 24 hours after aortic cross-clamp release [ Time Frame: 4) 24 hours after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - TNF-a - Preoperatively [ Time Frame: 1) Preoperatively (as a baseline) ]
    Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - TNF-a - 15 minutes after aortic cross-clamp [ Time Frame: 2) 15 minutes after aortic cross-clamping ]
    Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - TNF-a - 60 minutes after aortic cross-clamp [ Time Frame: 3) 60 minutes after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - TNF-a - 24 hours after aortic cross-clamp release [ Time Frame: 4) 24 hours after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - Cortisol - Preoperatively [ Time Frame: 1) Preoperatively (as a baseline) ]
    Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - Cortisol - 15 minutes after aortic cross-clamp [ Time Frame: 2) 15 minutes after aortic cross-clamping ]
    Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - Cortisol - 60 minutes after aortic cross-clamp [ Time Frame: 3) 60 minutes after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - Cortisol - 24 hours after aortic cross-clamp release [ Time Frame: 4) 24 hours after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - CRP - Preoperatively [ Time Frame: 1) Preoperatively (as a baseline) ]
    Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - CRP - 15 minutes after aortic cross-clamp [ Time Frame: 2) 15 minutes after aortic cross-clamping ]
    Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - CRP - 60 minutes after aortic cross-clamp [ Time Frame: 3) 60 minutes after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - CRP - 24 hours after aortic cross-clamp release [ Time Frame: 4) 24 hours after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - WBC - Preoperatively [ Time Frame: 1) Preoperatively (as a baseline) ]
    Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - WBC - 15 minutes after aortic cross-clamp [ Time Frame: 2) 15 minutes after aortic cross-clamping ]
    Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - WBC - 60 minutes after aortic cross-clamp [ Time Frame: 3) 60 minutes after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - WBC - 24 hours after aortic cross-clamp release [ Time Frame: 4) 24 hours after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.
  • Haemodynamic Stability - Mean PR [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean PR will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Minimum PR [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum PR values will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Maximum PR [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum PR will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Standard Deviation PR [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of the PR values will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - PR change induction [ Time Frame: 1 minute after anesthesia induction, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - PR change incision [ Time Frame: 1 minute after surgical incision, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - PR change clamp [ Time Frame: 1 minute after aortic clamping, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after aortic clamping, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - PR change clamp release 1 [ Time Frame: 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - PR change clamp release 2 [ Time Frame: 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - Mean SBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SAP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SBP will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Minimum SBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SAP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SBP will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Maximum SBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SAP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SBP will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Standard Deviation SBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SAP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of SBP values will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - SBP change induction [ Time Frame: 1 minute after anesthesia induction, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - SBP change incision [ Time Frame: 1 minute after surgical incision, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - SBP change clamp [ Time Frame: 1 minute after aortic clamping, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after aortic clamping, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - SBP change clamp release 1 [ Time Frame: 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - SBP change clamp release 2 [ Time Frame: 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - Mean DBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean DBP will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Minimum DBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum DBP will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Maximum DBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum DBP will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Standard Deviation DBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of DBP values will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - DBP change induction [ Time Frame: 1 minute after anesthesia induction, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - DBP change incision [ Time Frame: 1 minute after surgical incision, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - DBP change clamp [ Time Frame: 1 minute after aortic clamping, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after aortic clamping, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - DBP change clamp release 1 [ Time Frame: 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - DBP change clamp release 2 [ Time Frame: 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - Mean MBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean MBP will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Minimum MBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum MBP will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Maximum MBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum MBP will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Standard Deviation MBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of MBP values will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - MBP change induction [ Time Frame: 1 minute after anesthesia induction, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - MBP change incision [ Time Frame: 1 minute after surgical incision, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - MBP change clamp [ Time Frame: 1 minute after aortic clamping, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after aortic clamping, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - MBP change clamp release 1 [ Time Frame: 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - MBP change clamp release 2 [ Time Frame: 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - Mean CO [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean CO will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Minimum CO [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum CO will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Maximum CO [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum CO will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Standard Deviation CO [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of CO values will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Mean CI [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean CI will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Minimum CI [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum CI will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Maximum CI [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum CI will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Standard Deviation CI [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of CI values will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Mean SV [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SV will be reported for each patient, extracted from the collected data .
  • Haemodynamic Stability - Minimum SV [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SV will be reported for each patient, extracted from the collected data .
  • Haemodynamic Stability - Maximum SV [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SV will be reported for each patient, extracted from the collected data .
  • Haemodynamic Stability - Standard Deviation SV [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of SV values will be reported for each patient, extracted from the collected data .
  • Haemodynamic Stability - Mean SVV [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SVV will be reported for each patient, extracted from the collected data .
  • Haemodynamic Stability - Minimum SVV [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SVV will be reported for each patient, extracted from the collected data .
  • Haemodynamic Stability - Maximum SVV [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SVV will be reported for each patient, extracted from the collected data .
  • Haemodynamic Stability - Standard Deviation SVV [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of SVV values will be reported for each patient, extracted from the collected data .
  • Haemodynamic Stability - Mean SVI [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index- SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SVI will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Minimum SVI [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index- SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SVI will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Maximum SVI [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index- SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SVI will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Standard Deviation SVI [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index- SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of SVI values will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Tachycardia [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Intraoperative Tachycardia (defined as PR≥ 100 bpm), with episodes lasting ≥1 minute. Data will be reported in total seconds of intraoperative tachycardia.
  • Haemodynamic Stability - Bradycardia [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Intraoperative Bradycardia (defined as PR≤ 60 bpm), with episodes lasting ≥1 minute. Data will be reported in total seconds of intraoperative bradycardia.
  • Haemodynamic Stability - Hypotension [ Time Frame: Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Intraoperative Hypotension (defined as SBP≤100mmHg or ≤70% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline. Data will be reported in total seconds of intraoperative hypotension.
  • Haemodynamic Stability - Hypertension [ Time Frame: Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Intraoperative Hypertension (defined as SBP ≥130% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline. Data will be reported in total seconds of intraoperative hypertension.
  • Haemodynamic Stability - Fluid requirements - Crystalloids - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Crystaloid Fluid Requirements.
  • Haemodynamic Stability - Fluid requirements - Crystalloids - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Crystaloid Fluid Requirements.
  • Haemodynamic Stability - Fluid requirements - Colloids - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Colloid Fluid Requirements.
  • Haemodynamic Stability - Fluid requirements - Colloids - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Colloid Fluid Requirements.
  • Haemodynamic Stability - Fluid requirements - Concentrated RBCs - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Concentrated RBC unit Requirements.
  • Haemodynamic Stability - Fluid requirements - Concentrated RBCs - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Concentrated RBC unit Requirements.
  • Haemodynamic Stability - Fluid requirements - Plasma - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Plasma unit Requirements.
  • Haemodynamic Stability - Fluid requirements - Plasma - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Plasma unit Requirements.
  • Haemodynamic Stability - Fluid requirements - Platelets - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Platelet unit Requirements.
  • Haemodynamic Stability - Fluid requirements - Platelets - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Platelet unit Requirements.
  • Haemodynamic Stability - Blood Loss - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Blood Loss
  • Haemodynamic Stability - Blood Loss - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Blood Loss
  • Haemodynamic Stability - Fluid Balance - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Fluid Balance
  • Haemodynamic Stability - Fluid Balance - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Fluid Balance
  • Haemodynamic Stability - Vasoactive Requirements - Adrenaline - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Adrenaline requirements
  • Haemodynamic Stability - Vasoactive Requirements - Adrenaline - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Adrenaline requirements
  • Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Noradrenaline requirements
  • Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Noradrenaline requirements
  • Haemodynamic Stability - Vasoactive Requirements - Ephedrine - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Ephedrine requirements
  • Haemodynamic Stability - Vasoactive Requirements - Ephedrine - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Ephedrine requirements
  • Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Phenylephrine requirements
  • Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Phenylephrine requirements
  • Haemodynamic Stability - Vasoactive Requirements - Dobutamine - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Dobutamine requirements
  • Haemodynamic Stability - Vasoactive Requirements - Dobutamine - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Dobutamine requirements
  • Haemodynamic Stability - Vasoactive Requirements - Dopamine - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Dopamine requirements
  • Haemodynamic Stability - Vasoactive Requirements - Dopamine - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Dopamine requirements
  • Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Nitroglycerine requirements
  • Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Nitroglycerine requirements
Original Primary Outcome Measures  ICMJE
 (submitted: May 16, 2021)
  • Surgical Stress Response - IL-6 - Preoperatively [ Time Frame: 1) Preoperatively (as a baseline) ]
    Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-6 - 15 minutes after aortic cross-clamp [ Time Frame: 2) 15 minutes after aortic cross-clamping ]
    Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-6 - 60 minutes after aortic cross-clamp [ Time Frame: 3) 60 minutes after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-6 - 24 hours after aortic cross-clamp release [ Time Frame: 4) 24 hours after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-8 - Preoperatively [ Time Frame: 1) Preoperatively (as a baseline) ]
    Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-8 - 15 minutes after aortic cross-clamp [ Time Frame: 2) 15 minutes after aortic cross-clamping ]
    Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-8 - 60 minutes after aortic cross-clamp [ Time Frame: 3) 60 minutes after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-8 - 24 hours after aortic cross-clamp release [ Time Frame: 4) 24 hours after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-10 - Preoperatively [ Time Frame: 1) Preoperatively (as a baseline) ]
    Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-10 - 15 minutes after aortic cross-clamp [ Time Frame: 2) 15 minutes after aortic cross-clamping ]
    Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-10 - 60 minutes after aortic cross-clamp [ Time Frame: 3) 60 minutes after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - IL-10 - 24 hours after aortic cross-clamp release [ Time Frame: 4) 24 hours after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - AVP - Preoperatively [ Time Frame: 1) Preoperatively (as a baseline) ]
    Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - AVP - 15 minutes after aortic cross-clamp [ Time Frame: 2) 15 minutes after aortic cross-clamping ]
    Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - AVP - 60 minutes after aortic cross-clamp [ Time Frame: 3) 60 minutes after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - AVP - 24 hours after aortic cross-clamp release [ Time Frame: 4) 24 hours after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - TNF-a - Preoperatively [ Time Frame: 1) Preoperatively (as a baseline) ]
    Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - TNF-a - 15 minutes after aortic cross-clamp [ Time Frame: 2) 15 minutes after aortic cross-clamping ]
    Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - TNF-a - 60 minutes after aortic cross-clamp [ Time Frame: 3) 60 minutes after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - TNF-a - 24 hours after aortic cross-clamp release [ Time Frame: 4) 24 hours after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - Cortisol - Preoperatively [ Time Frame: 1) Preoperatively (as a baseline) ]
    Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - Cortisol - 15 minutes after aortic cross-clamp [ Time Frame: 2) 15 minutes after aortic cross-clamping ]
    Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - Cortisol - 60 minutes after aortic cross-clamp [ Time Frame: 3) 60 minutes after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - Cortisol - 24 hours after aortic cross-clamp release [ Time Frame: 4) 24 hours after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - CRP - Preoperatively [ Time Frame: 1) Preoperatively (as a baseline) ]
    Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - CRP - 15 minutes after aortic cross-clamp [ Time Frame: 2) 15 minutes after aortic cross-clamping ]
    Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - CRP - 60 minutes after aortic cross-clamp [ Time Frame: 3) 60 minutes after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - CRP - 24 hours after aortic cross-clamp release [ Time Frame: 4) 24 hours after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - WBC - Preoperatively [ Time Frame: 1) Preoperatively (as a baseline) ]
    Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - WBC - 15 minutes after aortic cross-clamp [ Time Frame: 2) 15 minutes after aortic cross-clamping ]
    Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - WBC - 60 minutes after aortic cross-clamp [ Time Frame: 3) 60 minutes after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.
  • Surgical Stress Response - WBC - 24 hours after aortic cross-clamp release [ Time Frame: 4) 24 hours after aortic cross-clamp release ]
    Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.
  • Haemodynamic Stability - Mean PR [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean PR will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Minimum PR [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum PR values will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Maximum PR [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum PR will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Standard Deviation PR [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of the PR values will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - PR change induction [ Time Frame: 1 minute after anesthesia induction, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - PR change incision [ Time Frame: 1 minute after surgical incision, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - PR change clamp [ Time Frame: 1 minute after aortic clamping, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after aortic clamping, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - PR change clamp release 1 [ Time Frame: 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - PR change clamp release 2 [ Time Frame: 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - Mean SBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SAP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SBP will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Minimum SBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SAP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SBP will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Maximum SBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SAP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SBP will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Standard Deviation SBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SAP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of SBP values will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - SBP change induction [ Time Frame: 1 minute after anesthesia induction, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - SBP change incision [ Time Frame: 1 minute after surgical incision, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - SBP change clamp [ Time Frame: 1 minute after aortic clamping, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after aortic clamping, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - SBP change clamp release 1 [ Time Frame: 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - SBP change clamp release 2 [ Time Frame: 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - Mean DBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean DBP will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Minimum DBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum DBP will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Maximum DBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum DBP will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Standard Deviation DBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of DBP values will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - DBP change induction [ Time Frame: 1 minute after anesthesia induction, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - DBP change incision [ Time Frame: 1 minute after surgical incision, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - DBP change clamp [ Time Frame: 1 minute after aortic clamping, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after aortic clamping, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - DBP change clamp release 1 [ Time Frame: 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - DBP change clamp release 2 [ Time Frame: 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - Mean MBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean MBP will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Minimum MBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum MBP will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Maximum MBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum MBP will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Standard Deviation MBP [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of MBP values will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - MBP change induction [ Time Frame: 1 minute after anesthesia induction, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - MBP change incision [ Time Frame: 1 minute after surgical incision, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - MBP change clamp [ Time Frame: 1 minute after aortic clamping, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after aortic clamping, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - MBP change clamp release 1 [ Time Frame: 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - MBP change clamp release 2 [ Time Frame: 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.
  • Haemodynamic Stability - Mean CO [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean CO will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Minimum CO [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum CO will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Maximum CO [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum CO will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Standard Deviation CO [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of CO values will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Mean CI [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean CI will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Minimum CI [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum CI will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Maximum CI [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum CI will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Standard Deviation CI [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of CI values will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Mean SV [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SV will be reported for each patient, extracted from the collected data .
  • Haemodynamic Stability - Minimum SV [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SV will be reported for each patient, extracted from the collected data .
  • Haemodynamic Stability - Maximum SV [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SV will be reported for each patient, extracted from the collected data .
  • Haemodynamic Stability - Standard Deviation SV [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of SV values will be reported for each patient, extracted from the collected data .
  • Haemodynamic Stability - Mean SVV [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SVV will be reported for each patient, extracted from the collected data .
  • Haemodynamic Stability - Minimum SVV [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SVV will be reported for each patient, extracted from the collected data .
  • Haemodynamic Stability - Maximum SVV [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SVV will be reported for each patient, extracted from the collected data .
  • Haemodynamic Stability - Standard Deviation SVV [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of SVV values will be reported for each patient, extracted from the collected data .
  • Haemodynamic Stability - Mean SVI [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index- SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SVI will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Minimum SVI [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index- SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SVI will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Maximum SVI [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index- SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SVI will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Standard Deviation SVI [ Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index- SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of SVI values will be reported for each patient, extracted from the collected data.
  • Haemodynamic Stability - Tachycardia [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Intraoperative Tachycardia (defined as PR≥ 100 bpm), with episodes lasting ≥1 minute. Data will be reported in total seconds of intraoperative tachycardia.
  • Haemodynamic Stability - Bradycardia [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Intraoperative Bradycardia (defined as PR≤ 60 bpm), with episodes lasting ≥1 minute. Data will be reported in total seconds of intraoperative bradycardia.
  • Haemodynamic Stability - Hypotension [ Time Frame: Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Intraoperative Hypotension (defined as SBP≤100mmHg or ≤30% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline. Data will be reported in total seconds of intraoperative hypotension.
  • Haemodynamic Stability - Hypertension [ Time Frame: Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Intraoperative Hypertension (defined as SBP ≥30% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline. Data will be reported in total seconds of intraoperative hypertension.
  • Haemodynamic Stability - Fluid requirements - Crystalloids - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Crystaloid Fluid Requirements.
  • Haemodynamic Stability - Fluid requirements - Crystalloids - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Crystaloid Fluid Requirements.
  • Haemodynamic Stability - Fluid requirements - Colloids - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Colloid Fluid Requirements.
  • Haemodynamic Stability - Fluid requirements - Colloids - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Colloid Fluid Requirements.
  • Haemodynamic Stability - Fluid requirements - Concentrated RBCs - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Concentrated RBC unit Requirements.
  • Haemodynamic Stability - Fluid requirements - Concentrated RBCs - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Concentrated RBC unit Requirements.
  • Haemodynamic Stability - Fluid requirements - Plasma - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Plasma unit Requirements.
  • Haemodynamic Stability - Fluid requirements - Plasma - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Plasma unit Requirements.
  • Haemodynamic Stability - Fluid requirements - Platelets - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Platelet unit Requirements.
  • Haemodynamic Stability - Fluid requirements - Platelets - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Platelet unit Requirements.
  • Haemodynamic Stability - Blood Loss - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Blood Loss
  • Haemodynamic Stability - Blood Loss - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Blood Loss
  • Haemodynamic Stability - Fluid Balance - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Fluid Balance
  • Haemodynamic Stability - Fluid Balance - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Fluid Balance
  • Haemodynamic Stability - Vasoactive Requirements - Adrenaline - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Adrenaline requirements
  • Haemodynamic Stability - Vasoactive Requirements - Adrenaline - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Adrenaline requirements
  • Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Noradrenaline requirements
  • Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Noradrenaline requirements
  • Haemodynamic Stability - Vasoactive Requirements - Ephedrine - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Ephedrine requirements
  • Haemodynamic Stability - Vasoactive Requirements - Ephedrine - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Ephedrine requirements
  • Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Phenylephrine requirements
  • Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Phenylephrine requirements
  • Haemodynamic Stability - Vasoactive Requirements - Dobutamine - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Dobutamine requirements
  • Haemodynamic Stability - Vasoactive Requirements - Dobutamine - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Dobutamine requirements
  • Haemodynamic Stability - Vasoactive Requirements - Dopamine - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Dopamine requirements
  • Haemodynamic Stability - Vasoactive Requirements - Dopamine - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Dopamine requirements
  • Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - Intraoperatively [ Time Frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Nitroglycerine requirements
  • Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - 24 hours postoperatively [ Time Frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively ]
    Haemodynamic Stability as quantified by hemodynamic markers, specifically Nitroglycerine requirements
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2021)
  • Postoperative pain - Numerical Rating Scale (NRS) - Immediately Postoperatively [ Time Frame: 1) Immediately postoperatively (if awakened prior to ICU admission) ]
    Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
  • Postoperative pain - Numerical Rating Scale (NRS) - First postoperative day [ Time Frame: 2) First postoperative day ]
    Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
  • Postoperative pain - Numerical Rating Scale (NRS) - Second postoperative day [ Time Frame: 3) Second postoperative day ]
    Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
  • Postoperative pain - Numerical Rating Scale (NRS) - Third postoperative day [ Time Frame: 4) Third postoperative day ]
    Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
  • Postoperative pain - Critical Care Pain Observation Tool (CPOT) - Immediately Postoperatively [ Time Frame: 1) Immediately postoperatively (if awakened prior to ICU admission) ]
    Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).
  • Postoperative pain - Critical Care Pain Observation Tool (CPOT) - First postoperative day [ Time Frame: 2) First postoperative day ]
    Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).
  • Postoperative pain - Critical Care Pain Observation Tool (CPOT) - Second postoperative day [ Time Frame: 3) Second postoperative day ]
    Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).
  • Postoperative pain - Critical Care Pain Observation Tool (CPOT) - Third postoperative day [ Time Frame: 4) Third postoperative day ]
    Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - First postoperative day [ Time Frame: 1) First postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain
    The percentage of patients that report pain that is "Intolerable" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Second postoperative day [ Time Frame: 2) Second postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain
    The percentage of patients that report pain that is "Intolerable" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Third postoperative day [ Time Frame: 3) Third postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain
    The percentage of patients that report pain that is "Intolerable" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - First postoperative day [ Time Frame: 1) First postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain
    The percentage of patients that report pain that is "Tolerable with discomfort" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Second postoperative day [ Time Frame: 2) Second postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain
    The percentage of patients that report pain that is "Tolerable with discomfort" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Third postoperative day [ Time Frame: 3) Third postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain
    The percentage of patients that report pain that is "Tolerable with discomfort" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - First postoperative day [ Time Frame: 1) First postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain
    The percentage of patients that report pain that is "Comfortably manageable" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Second postoperative day [ Time Frame: 2) Second postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain
    The percentage of patients that report pain that is "Comfortably manageable" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Third postoperative day [ Time Frame: 3) Third postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain
    The percentage of patients that report pain that is "Comfortably manageable" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - First postoperative day [ Time Frame: 1) First postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain
    The percentage of patients that report pain that is "Negligible Pain" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Second postoperative day [ Time Frame: 2) Second postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain
    The percentage of patients that report pain that is "Negligible Pain" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Third postoperative day [ Time Frame: 3) Third postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain
    The percentage of patients that report pain that is "Negligible Pain" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - First postoperative day [ Time Frame: 1) First postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
    1. Getting worse
    2. About the same
    3. Getting better
    The percentage of patients that report pain that is "Getting worse" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Second postoperative day [ Time Frame: 2) Second postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
    1. Getting worse
    2. About the same
    3. Getting better
    The percentage of patients that report pain that is "Getting worse" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Third postoperative day [ Time Frame: 3) Third postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
    1. Getting worse
    2. About the same
    3. Getting better
    The percentage of patients that report pain that is "Getting worse" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - First postoperative day [ Time Frame: 1) First postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
    1. Getting worse
    2. About the same
    3. Getting better
    The percentage of patients that report pain that is "About the same" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Second postoperative day [ Time Frame: 2) Second postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
    1. Getting worse
    2. About the same
    3. Getting better
    The percentage of patients that report pain that is "About the same" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Third postoperative day [ Time Frame: 3) Third postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
    1. Getting worse
    2. About the same
    3. Getting better
    The percentage of patients that report pain that is "About the same" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better [ Time Frame: 1) First postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
    1. Getting worse
    2. About the same
    3. Getting better
    The percentage of patients that report pain that is "Getting better" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Second postoperative day [ Time Frame: 2) Second postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
    1. Getting worse
    2. About the same
    3. Getting better
    The percentage of patients that report pain that is "Getting better" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Third postoperative day [ Time Frame: 3) Third postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
    1. Getting worse
    2. About the same
    3. Getting better
    The percentage of patients that report pain that is "Getting better" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - First postoperative day [ Time Frame: 1) First postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
    1. Inadequate pain control
    2. Effective, just about right
    3. Would like to reduce medication
    The percentage of patients that report "Inadequate pain control" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Second postoperative day [ Time Frame: 2) Second postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
    1. Inadequate pain control
    2. Effective, just about right
    3. Would like to reduce medication
    The percentage of patients that report "Inadequate pain control" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Third postoperative day [ Time Frame: 3) Third postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
    1. Inadequate pain control
    2. Effective, just about right
    3. Would like to reduce medication
    The percentage of patients that report "Inadequate pain control" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - First postoperative day [ Time Frame: 1) First postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
    1. Inadequate pain control
    2. Effective, just about right
    3. Would like to reduce medication
    The percentage of patients that report pain control that is "Effective, just about right" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Second postoperative day [ Time Frame: 2) Second postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
    1. Inadequate pain control
    2. Effective, just about right
    3. Would like to reduce medication
    The percentage of patients that report pain control that is "Effective, just about right" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Third postoperative day [ Time Frame: 3) Third postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
    1. Inadequate pain control
    2. Effective, just about right
    3. Would like to reduce medication
    The percentage of patients that report pain control that is "Effective, just about right" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - First postoperative day [ Time Frame: 1) First postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
    1. Inadequate pain control
    2. Effective, just about right
    3. Would like to reduce medication
    The percentage of patients whose pain control is reported as "Would like to reduce medication" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Second postoperative day [ Time Frame: 2) Second postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
    1. Inadequate pain control
    2. Effective, just about right
    3. Would like to reduce medication
    The percentage of patients whose pain control is reported as "Would like to reduce medication" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Third postoperative day [ Time Frame: 3) Third postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
    1. Inadequate pain control
    2. Effective, just about right
    3. Would like to reduce medication
    The percentage of patients whose pain control is reported as "Would like to reduce medication" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - First postoperative day [ Time Frame: 1) First postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do
    The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Second postoperative day [ Time Frame: 2) Second postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do
    The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Third postoperative day [ Time Frame: 3) Third postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do
    The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - First postoperative day [ Time Frame: 1) First postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do
    The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - Second postoperative day [ Time Frame: 2) Second postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do
    The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - Third postoperative day [ Time Frame: 3) Third postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do
    The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - First postoperative day [ Time Frame: 1) First postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do
    The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - Second postoperative day [ Time Frame: 2) Second postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do
    The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - Third postoperative day [ Time Frame: 3) Third postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do
    The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - First postoperative day [ Time Frame: 1) First postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do
    The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Second postoperative day [ Time Frame: 2) Second postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do
    The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Third postoperative day [ Time Frame: 3) Third postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do
    The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - First postoperative day [ Time Frame: 1) First postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
    1. Awake with pain most of the night
    2. Awake with occasional pain
    3. Normal sleep
    The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Second postoperative day [ Time Frame: 2) Second postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
    1. Awake with pain most of the night
    2. Awake with occasional pain
    3. Normal sleep
    The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Third postoperative day [ Time Frame: 3) Third postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
    1. Awake with pain most of the night
    2. Awake with occasional pain
    3. Normal sleep
    The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - First postoperative day [ Time Frame: 1) First postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
    1. Awake with pain most of the night
    2. Awake with occasional pain
    3. Normal sleep
    The percentage of patients whose sleep is reported as "Awake with occasional pain" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Second postoperative day [ Time Frame: 2) Second postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
    1. Awake with pain most of the night
    2. Awake with occasional pain
    3. Normal sleep
    The percentage of patients whose sleep is reported as "Awake with occasional pain" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Third postoperative day [ Time Frame: 3) Third postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
    1. Awake with pain most of the night
    2. Awake with occasional pain
    3. Normal sleep
    The percentage of patients whose sleep is reported as "Awake with occasional pain" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - First postoperative day [ Time Frame: 1) First postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
    1. Awake with pain most of the night
    2. Awake with occasional pain
    3. Normal sleep
    The percentage of patients whose sleep is reported as "Normal sleep" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Second postoperative day [ Time Frame: 2) Second postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
    1. Awake with pain most of the night
    2. Awake with occasional pain
    3. Normal sleep
    The percentage of patients whose sleep is reported as "Normal sleep" will be reported
  • Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Third postoperative day [ Time Frame: 3) Third postoperative day ]
    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
    1. Awake with pain most of the night
    2. Awake with occasional pain
    3. Normal sleep
    The percentage of patients whose sleep is reported as "Normal sleep" will be reported
  • Analgesic Requirements - First postoperative day [ Time Frame: 1) First postoperative day ]
    Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.
  • Analgesic Requirements - Second postoperative day [ Time Frame: 2) Second postoperative day ]
    Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.
  • Analgesic Requirements - Third postoperative day [ Time Frame: 3) Third postoperative day ]
    Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair
Official Title  ICMJE Effect of a Perioperative Opioid Free Anesthesia-Analgesia (OFA-A) Strategy on Surgical Stress Response in Elective Open Abdominal Aortic Aneurysm Repair: A Prospective Randomized Study
Brief Summary

Open Abdominal Aortic Aneurysm (AAA) repair is a high-risk surgical procedure accompanied by intense endocrine and metabolic responses to surgical stress, with subsequent activation of the inflammatory cascade, cytokine and acute-phase protein release, and bone marrow activation. There is a proven correlation of surgical stress, which patients undergoing open AAA repair are subjected to, with patient outcome, morbidity/mortality, intensive care unit stay and overall length of stay. Modern general anesthetic techniques have been revised and rely on perioperative multimodal anesthetic and analgesic strategies for improved overall patient outcome. Based on this context of a multimodal anesthetic technique and having taken into consideration the international "opioid-crisis" epidemic, an Opioid Free Anesthesia-Analgesia (OFA-A) strategy started to emerge. It is based on the administration of a variety of anesthetic/analgesic agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects.

Our basic hypothesis is that the implementation of a perioperative multimodal OFA-A strategy, involving the administration of pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, dexketoprofen, paracetamol and magnesium sulphate, will lead to attenuation of surgical stress response compared to a conventional Opioid-Based Anesthesia-Analgesia (OBA-A) strategy. Furthermore, the anticipated attenuation of the inflammatory response, is pressumed to be associated with equal or improved analgesia, compared to a perioperative OBA-A technique.

Detailed Description

Open abdominal aortic aneurysm (AAA) repair surgery is a high-risk operation, often performed on high-risk patients. Despite advancements made in diagnosis, management, surgical techniques and treatment of these patients, morbidity and mortality remain high. Mortality after open AAA repair remains higher than the average mortality of the matched population for age and sex. Debate is ongoing as to whether open AAA repair or endovascular aneurysm repair (EVAR) is better in terms of overall long-term survival rate.

Regarding open AAA repair, the very nature of the surgery itself, with surgical trauma, aortic cross clamping and its resulting ischemia-reperfusion injury, and cellular interactions of blood with the biomaterial surface of the graft, causes intense and varied metabolic, endocrine and immunological responses. These surgical stress-related responses are evident as marked increases in inflammatory cytokines such as TNF-a, IL-1a, IL-6, IL-8, IL-10, stimulation of the sympathetic system, and stimulation of the hypothalamic-pituitary-adrenal axis, caused by release of CRH and AVP. High levels of IL-6, peaking at 4-48h after clamp removal, have been associated with serious postoperative complications and its levels reflect the intensity of surgical trauma following AAA repair. Other inflammation markers such as CRP and leukocytes have also been shown to increase postoperatively.

While the surgical technique has been extensively studied as to the role it plays on the control of the surgical stress response, patient outcome, morbidity and overall mortality, fewer studies have been conducted to study the effect of the anesthetic management on these factors. While most of them have been focusing on the comparison of general anesthetic vs regional techniques, only few compare different general anesthetic techniques on patient outcome.

Modern general anesthetic techniques have been revised and rely on a multimodal anesthetic and analgesic perioperative regimen for improved patient outcome. A multimodal regimen requires the administration of at least 2 factors with different mechanisms of action. At least one factor causes inhibition of central sensitization and at least another one inhibits the peripheral sensitization of the nervous system, as a response to painful surgical stimuli, mitigating adverse neuroplasticity. One such example, is an Opioid-Free Anesthetic-Analgesic (OFA-A) strategy, which implements a variety of pharmacological agents, including some with demonstrated immunomodulating and anti-inflammatory effects. Apart from sparing any opioid-related adverse effects, an OFA-A multimodal strategy targets optimal analgesia with a multitude of factors in the lowest possible dose, aiming for additive or synergistic effects. An additional advantage of using an OFA-A technique is the prevention of opioid-induced hyperalgesia.

Our hypothesis is that implementation of a multimodal OFA-A strategy, leads to a decreased sympathetic and inflammatory response, compared to conventional opioid-based anesthetic techniques. A decreased inflammatory and stress response as expressed by reduced levels of IL-6, IL-8, IL-10, TNF-a, CRP, cortisol, arginine vasopressin (AVP), white blood cells count and hemodynamic stability is expected to decrease peripheral and central sensitization, contributing to better postoperative analgesia.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Implementation of a multimodal anesthetic opioid-free strategy, that includes the administration of pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, magnesium sulphate, paracetamol and dexketoprofen is anticipated to modulate the inflammatory and stress response, as measured by levels of inflammatory markers and haemodynamic stability, compared to conventional anesthetic opioid-based techniques. Furthermore, a decreased inflammatory and stress response, as expressed by reduced levels of inflammatory biomarkers and hemodynamic stability, is expected to decrease peripheral and central sensitization, contributing to better postoperative analgesia.
Masking: Double (Participant, Investigator)
Masking Description:
Laboratory data analysis collaborators
Primary Purpose: Basic Science
Condition  ICMJE
  • Elective Surgical Procedures
  • Postoperative Pain
  • Anesthesia
  • Opioid Use
  • Abdominal Aortic Aneurysm Without Rupture
  • Vascular Surgical Procedure
  • Interleukin 6
  • Immunomodulators
Intervention  ICMJE
  • Drug: Opioid-Based Anesthesia-Analgesia Strategy
    A perioperative Opioid-Based multimodal Anesthesia-Analgesia strategy will be implemented as described in the Opioid-Based arm of the study.
    Other Names:
    • Opioid-Based Anesthesia
    • OBA-A
  • Drug: Opioid-free Anesthesia-Analgesia Strategy
    A perioperative Opioid-Free multimodal Anesthesia-Analgesia strategy will be implemented as described in the Opioid-Free arm of the study.
    Other Names:
    • Opioid-Free Anesthesia
    • OFA-A
Study Arms  ICMJE
  • Active Comparator: Opioid-Based Anesthesia Analgesia
    Premedication: IM Midazolam 0.05-0.07mg/kg. Anesthesia induction: Midazolam 0.03mg/kg, Propofol 2-3mg/kg, Fentanyl 1-2mcg/kg and Cisatracurium 0.2mg/kg or alternatively Rocuronium 0.6-1.2mg/kg. Anesthesia maintenance: Desflurane set at approximately 1 MAC, Morphine 0.1-0.12mg/kg, Fentanyl 1-2mcg/kg during induction and 50-100mcg prn, Paracetamol 1g +/- Dexketoprofen trometamol 50mg, along with Ondansetron 4mg or Droperidol 0.625mg. Wound infiltration: Ropivacaine 75-150mg. ICU stay sedation: Remifentanil infusion, until removal of the endotracheal tube. Surgical ward: PCA pump with Morphine for the first 3 postoperative days. Additional postoperative analgesia: Paracetamol 1g x3 +/- Dexketoprofen trometamol 50mg x2. Rescue therapy only: Tramadol 50-100mg.
    Intervention: Drug: Opioid-Based Anesthesia-Analgesia Strategy
  • Active Comparator: Opioid-Free Anesthesia Analgesia
    Premedication: Pregabalin 50-150mg x2, IM Midazolam 0.05-0.07mg/kg. Anesthesia induction: Midazolam 0.03mg/kg, Dexdmedetomidine 0.5-1mcg/kg, Lidocaine 1mg/kg, Propofol 2-3mg/kg, Ketamine 1-1.5mg/kg, Hyoscine 10mg, Cisatracurium 0.2mg/kg or alternatively Rocuronium 0.6-1.2mg/kg, Magnesium sulphate 2.5-5g and Dexamethasone 8-16mg. Anesthesia maintenance: Desflurane set at ~1 MAC, Dexmedetomidine 0.2-1.2mcg/kg/h, Lidocaine 0.5-1mg/kg/h, Ketamine 0.3-0.5mg/kg prn, Paracetamol 1g +/- Dexketoprofen trometamol 50mg, and Ondansetron 4mg or Droperidol 0.625mg. Wound infiltration: Ropivacaine 75-150mg. ICU sedation: Dexmedetomidine + Lidocaine infusions, until removal of the ETT. Surgical ward: PCA pump with Ketamine, Lidocaine, Clonidine, Droperidol and Midazolam for the first 3 postoperative days. Additionally, Pregabalin 50mg per os x1 and 25mg x1, Paracetamol 1g x3 +/- Dexketoprofen trometamol 50mg x2. Rescue therapy only: Tramadol 50-100mg.
    Intervention: Drug: Opioid-free Anesthesia-Analgesia Strategy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 16, 2021)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 8, 2025
Estimated Primary Completion Date October 8, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient Consent
  2. Age between 40 and 85 years old
  3. Patients undergoing Elective Open Abdominal Aortic Infrarenal Aneurysm Repair
  4. AAA Diameter ≥ 5,0 cm

Exclusion Criteria:

  1. Immunocompromised patients
  2. Patients with active infection
  3. Reoperation on the aorta
  4. Inflammatory bowel Disease
  5. Malignancy
  6. Chronic Inflammatory conditions (e.g. Rheymatoid arthritis, Psoriatic arthritis)
  7. Chronic corticosteroid or immunosuppressive drug use
  8. Transfusion with >3 units of packed red blood cells
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: George Papastratigakis, MD 00306979056672 papastratigakisg@gmail.com
Contact: Georgios Stefanakis, MD 00306978779726 G_Stefanakis@yahoo.com
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04894864
Other Study ID Numbers  ICMJE OFA-aneurysm
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party George Papastratigakis, MD, University of Crete
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Crete
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University Hospital of Crete
Investigators  ICMJE
Study Chair: Vasileia Nyktari, MD,PhD University of Crete, Medical School
PRS Account University of Crete
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP