Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sevoflurane Decreases the Risk of Postoperative Delirium After Cerebral Hypoxemia During Surgery

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02133638
Recruitment Status : Unknown
Verified May 2014 by Negovsky Reanimatology Research Institute.
Recruitment status was:  Recruiting
First Posted : May 8, 2014
Last Update Posted : May 8, 2014
Sponsor:
Information provided by (Responsible Party):
Negovsky Reanimatology Research Institute

Brief Summary:
The aim of this study is to distinguish possible differences in frequency of delirium after Volatile Induction and Maintenance of Anesthesia and Total Intravenous Anesthesia in case of undeliberate cerebral desaturation during non-cardiac surgery.

Condition or disease Intervention/treatment Phase
Cerebral Hypoxia Postoperative Delirium Drug: Sevoflurane Drug: Propofol Phase 4

Detailed Description:
The aim of the present study is to investigate whether in non-cardiac surgery the frequency of POD after intraoperative undeliberate cerebral saturation could be modulated by the choice of the anesthetic strategy (Volatile Induction and Maintenance of Anesthesia [VIMA] and Total Intravenous Anesthesia [TIVA]). Based on our previous data we hypothesized that incidence of POD would be lower with VIMA compared to TIVA.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sevoflurane-based Volatile Induction and Maintenance of Anaesthesia (VIMA) Strategy Decreases the Risk of Postoperative Delirium in Elderly Patients With Registered Cerebral Hypoxemia Episodes During General Surgery
Study Start Date : May 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Active Comparator: Sevoflurane
Sevoflurane Based Volatile Induction and Maintenance of Anaesthesia
Drug: Sevoflurane
Induction of anesthesia: fentanyl 2 µg kg-1 and a bolus inhalation of 8% sevoflurane in an 8 L.min-1 fresh gas flow. Anesthesia maintenance: 1 minimal alveolar concentration (MAC) sevoflurane at a low fresh gas flow of 0.6-0.8 L min-1 in a 60% air-oxygen mixture supplemented with boluses of fentanyl.
Other Names:
  • Sevorane
  • Ultane
  • Fluoromethyl hexafluoroisopropyl ether

Active Comparator: Propofol
Propofol Based Total Intravenous Anesthesia
Drug: Propofol
Induction of anesthesia: propofol 2 mg kg-1 and fentanyl 4 µg kg-1. Maintenance of anesthesia: infusion of propofol 8 mg kg-1 h-1 and boluses of fentanyl 3 µg kg-1.
Other Names:
  • Diprivan
  • Lipuro
  • Propolipid
  • Propoven
  • Recofol
  • Unifol




Primary Outcome Measures :
  1. Regional Cerebral Oxygenation (rSO2) [ Time Frame: Continued the entire surgery ]
  2. Peripheral tissue oxygen saturation (SpO2) [ Time Frame: Continued the entire surgery ]
  3. Non-invasive blood pressure (NIBP) [ Time Frame: Continued the entire surgery ]

Secondary Outcome Measures :
  1. Number of Incidences of postoperative delirium (POD) [ Time Frame: Baseline, 24h and 48h after surgery ]
    Applying the Confusion Assessment Method for the ICU (CAM-ICU)

  2. Plasma concentration of S100b protein [ Time Frame: Baseline, 24h and 48h after surgery ]
    S100b protein is the neuronal injury marker



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • class III-IV by physical status classification system of American Society of Anesthesiologist (ASA)
  • history of arterial vascular disease (arterial hypertension, myocardial ischemia and/or cerebral vascular disease)
  • undergoing elective non-cardiac surgery (hemicolectomy, hernioplasty, laparoscopic cholecystectomy and laparoscopic hysterectomy)

Exclusion Criteria:

  • dementia
  • stroke or myocardial infarction ≤ 6 months before surgery
  • oncological disease of T2-4N3M1 stage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02133638


Contacts
Layout table for location contacts
Contact: Valery V. Likhvantsev, MD, Prof. lik0704@gmail.com

Locations
Layout table for location information
Russian Federation
Medical center of the Main Administration for Service to the Diplomatic Corps Recruiting
Moscow, Russian Federation
Contact: Yuri V. Skripkin       skripkin62@gmail.com   
Sponsors and Collaborators
Negovsky Reanimatology Research Institute
Investigators
Layout table for investigator information
Study Chair: Valery V. Likhvantsev, MD, Prof. Negovsky Reanimatology Research Institute, Moscow, Russia
Study Director: Oleg A. Grebenchikov, MD, PhD Negovsky Reanimatology Research Institute, Moscow, Russia
Principal Investigator: Yuri V. Iljin Negovsky Reanimatology Research Institute, Moscow, Russia
Principal Investigator: Alexander V. Mironenko, MD, PhD Negovsky Reanimatology Research Institute, Moscow, Russia
Principal Investigator: Yuri V. Skripkin Negovsky Reanimatology Research Institute, Moscow, Russia
Principal Investigator: Dmitriy B. Selivanov, MD, PhD Hospital Maria Vittoria, Turin, Italy

Layout table for additonal information
Responsible Party: Negovsky Reanimatology Research Institute
ClinicalTrials.gov Identifier: NCT02133638     History of Changes
Other Study ID Numbers: Sev003
s100b ( Other Identifier: s100b )
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: May 8, 2014
Last Verified: May 2014
Keywords provided by Negovsky Reanimatology Research Institute:
Delirium
Hypoxic Brain Damage
Propofol
S100b protein
Sevoflurane
Additional relevant MeSH terms:
Layout table for MeSH terms
Delirium
Hypoxia, Brain
Hypoxia
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Signs and Symptoms, Respiratory
Brain Diseases
Central Nervous System Diseases
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation