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Cardiac Output and Duplex Sonography in Carotid Endarterectomy

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ClinicalTrials.gov Identifier: NCT02230358
Recruitment Status : Unknown
Verified April 2016 by Priv.Doz. Dr. Corinna Velik-Salchner, Medical University Innsbruck.
Recruitment status was:  Recruiting
First Posted : September 3, 2014
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
Priv.Doz. Dr. Corinna Velik-Salchner, Medical University Innsbruck

Brief Summary:
The aim of this study is to investigate the differences between the cardiac output and the cerebral blood-flow between a regional anesthesia (RA) and a general anesthesia (GA) in a randomized, controlled, single center study at the Medical University Innsbruck, Department of Anesthesia and Intensive Care Medicine.

Condition or disease Intervention/treatment Phase
Carotid Stenosis Procedure: Regional anesthesia Procedure: General anesthesia Device: Transcranial Doppler ultrasonography Procedure: blood gas analysis Procedure: invasive arterial blood pressure measurement Procedure: arterial blood gas measurement Behavioral: Neurological Control Behavioral: NIRS monitoring Device: oxygen supply (not invasive 'Vigileo') Not Applicable

Detailed Description:

The investigators will investigate the differences between the cardiac output and the cerebral blood-flow between a regional anesthesia (RA) and a general anesthesia (GA) in a randomized, controlled, single center study at the Medical University Innsbruck, Department of Anesthesia and Intensive Care Medicine.

For this purpose patients with the need of a carotid endarterectomy (CEA) will be included and randomized either to the regional anesthesia (RA) or the general anesthesia (GA) group until a patient number of 45 in each group is achieved.

The cardiac output and cerebral blood-flow via trans-cranial Doppler (TCD) will be measured at 6 time points:

  • T0 Baseline (after insertion of an arterial line)
  • T1 After induction of anesthesia, but before surgical start
  • T2 Two minutes after clamping the carotid artery
  • T3 Two minutes after shunt insertation of the carotid artery
  • T4 After reperfusion
  • T5 After completion of the skin suture

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cardiac Output and Cerebral Blood-flow During Carotid Endarterectomy in Regional vs. General Anesthesia. A Prospective Randomized Controlled Single Center Study
Study Start Date : July 2014
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Arm Intervention/treatment
Regional anesthesia (RA)
Regional anesthesia (RA) for a carotid endarterectomy Interventions: Regional anesthesia (RA), blood gas analysis, 'Transcranieller Doppler' (Transcranial Doppler ultrasonography), invasive arterial blood pressure measurement, arterial blood gas measurement, neurological control, Near-infrared spectroscopy (NIRS) monitoring, oxygen supply (not invasive 'Vigileo')
Procedure: Regional anesthesia
Regional anesthesia

Device: Transcranial Doppler ultrasonography
6x for 4 hours

Procedure: blood gas analysis
6 x 3 ml blood withdrawal (18 ml) within 4 hours

Procedure: invasive arterial blood pressure measurement
before operation, 8 hours, as done in clinical routine

Procedure: arterial blood gas measurement
perioperative, 4-6 times within 8 hours, as done in clinical routine

Behavioral: Neurological Control
perioperative, 2-3 days, as done in clinical routine

Behavioral: NIRS monitoring
perioperative, for 5 hours, as done in clinical routine

Device: oxygen supply (not invasive 'Vigileo')
perioperative for 5 hours, as done in clinical routine

General anesthesia (GA)
General anesthesia (GA) for a carotid endarterectomy Interventions: General anesthesia, blood gas analysis, 'Transcranieller Doppler' (Transcranial Doppler ultrasonography), invasive arterial blood pressure measurement, arterial blood gas measurement, neurological control, NIRS monitoring, oxygen supply (not invasive 'Vigileo')
Procedure: General anesthesia
General anesthesia

Device: Transcranial Doppler ultrasonography
6x for 4 hours

Procedure: blood gas analysis
6 x 3 ml blood withdrawal (18 ml) within 4 hours

Procedure: invasive arterial blood pressure measurement
before operation, 8 hours, as done in clinical routine

Procedure: arterial blood gas measurement
perioperative, 4-6 times within 8 hours, as done in clinical routine

Behavioral: Neurological Control
perioperative, 2-3 days, as done in clinical routine

Behavioral: NIRS monitoring
perioperative, for 5 hours, as done in clinical routine

Device: oxygen supply (not invasive 'Vigileo')
perioperative for 5 hours, as done in clinical routine




Primary Outcome Measures :
  1. Influence of anesthetic technique on cardiac output during carotid endarterectomy. [ Time Frame: Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit ]

    Number of participants: 90 patients

    Unit of measure: Cardiac index (l/m2)

    Cardiac output will be measured and compared at the following time points:

    • T0 Baseline (after insertion of an arterial line)
    • T1 After induction of anesthesia, but before surgical start
    • T2 Two minutes after clamping the carotid artery
    • T3 Two minutes after shunt insertation of the carotid artery
    • T4 After reperfusion
    • T5 After completion of the skin suture


Secondary Outcome Measures :
  1. Influence of anesthetic technique on trans-cranial doppler flow during carotid endarterectomy. [ Time Frame: Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit ]

    Cerebral blood flow will be measured via trans-cranial Doppler (TCD) and compared at the following time points:

    • T0 Baseline (after insertion of an arterial line)
    • T1 After induction of anesthesia, but before surgical start
    • T2 Two minutes after clamping the carotid artery
    • T3 Two minutes after shunt insertation of the carotid artery
    • T4 After reperfusion
    • T5 After completion of the skin suture


Other Outcome Measures:
  1. Influence of anesthetic technique on near infrared spectroscopy during carotid endarterectomy. [ Time Frame: Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit ]

    Number of participants: 90 patients

    Unit of measure: blood flow, volume and absolute tissue saturation

    Near infrared spectroscopy will be measured and compared at the following time points:

    • T0 Baseline (after insertion of an arterial line)
    • T1 After induction of anesthesia, but before surgical start
    • T2 Two minutes after clamping the carotid artery
    • T3 Two minutes after shunt insertation of the carotid artery
    • T4 After reperfusion
    • T5 After completion of the skin suture

  2. Influence of anesthetic technique on blood pressure during carotid endarterectomy. [ Time Frame: Change of blood pressure, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit ]

    Number of participants: 90 patients

    Unit of measure: blood pressure in mmHg

    Blood pressure will be measured and compared at the following time points:

    • T0 Baseline (after insertion of an arterial line)
    • T1 After induction of anesthesia, but before surgical start
    • T2 Two minutes after clamping the carotid artery
    • T3 Two minutes after shunt insertation of the carotid artery
    • T4 After reperfusion
    • T5 After completion of the skin suture

  3. Percentage of participants with death. [ Time Frame: Up to 6 months ]
  4. Number of participants with transient ischemic attack and neck hematoma requiring surgical revision. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]
  5. Percentage of participants with myocardial infarction. [ Time Frame: Up to 6 months ]
  6. Percentage of participants with stroke. [ Time Frame: Up to 6 months ]
  7. Influence of anesthetic technique on heart rate during carotid endarterectomy [ Time Frame: Change of heart rate, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit ]

    Change of heart rate, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit

    Number of participants: 90 patients

    Unit of measure: beats per minute (bpm)

    Heart rate will be measured and compared at the following time points:

    • T0 Baseline (after insertion of an arterial line)
    • T1 After induction of anesthesia, but before surgical start
    • T2 Two minutes after clamping the carotid artery
    • T3 Two minutes after shunt insertation of the carotid artery
    • T4 After reperfusion
    • T5 After completion of the skin suture

  8. Influence of anesthetic technique on blood gas analysis during carotid endarterectomy [ Time Frame: Change of oxygen saturation in blood, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit ]

    Number of participants: 90 patients

    Unit of measure: arterial oxygen tension (PaO2)

    Blood pressure will be measured and compared at the following time points:

    • T0 Baseline (after insertion of an arterial line)
    • T1 After induction of anesthesia, but before surgical start
    • T2 Two minutes after clamping the carotid artery
    • T3 Two minutes after shunt insertation of the carotid artery
    • T4 After reperfusion
    • T5 After completion of the skin suture



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >= 18 years
  2. Elective carotid endarterectomy
  3. Signed informed consent

Exclusion Criteria:

  1. Age under 18 years
  2. Missing signed informed consent

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): NCT02230358


Locations
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Austria
Medical University Innsbruck Recruiting
Innsbruck, Tirol, Austria, 6020
Contact: Corinna Velik-Salchner, MD    +43512504 ext 80368    corinna.velik@uki.at   
Principal Investigator: Corinna Velik-Salchner, PrivDoz. Dr.         
Sponsors and Collaborators
Medical University Innsbruck
Investigators
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Principal Investigator: Corinna Velik-Salchner, PrivDoz.Dr. Medical University Innsbruck

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Responsible Party: Priv.Doz. Dr. Corinna Velik-Salchner, Priv.-Doz. Dr., Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT02230358     History of Changes
Other Study ID Numbers: CODUCE
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: April 2016

Keywords provided by Priv.Doz. Dr. Corinna Velik-Salchner, Medical University Innsbruck:
carotid endarterectomy
cardiac output
trans-cranial Doppler
CEA
regional anesthesia
general anesthesia

Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs