The Effects of Anaesthesia on Cerebral Oxygenation and Cognitive Function in Carotid Endarterectomy (CEE-VIMA)
Study Overview
Status
Intervention / Treatment
Detailed Description
Background: A transient deterioration of cerebral hemodynamics and oxygenation during CEE might involve both hemispheres of the brain and affects postoperative cognition. Despite some benefits of regional blocks, the majority of procedures of carotid endarterectomy (CEE) are performed under general anaesthesia. Surprisingly, the studies comparing the effects of sevoflurane and propofol on postoperative mental state in CEE are scarce and controversial. While propofol possesses some anti-inflammatory properties, volatile anesthetics can interfere with cerebral blood flow and reperfusion-ischaemia injury via the mechanism of pre- and postconditioning. The goal of this study is to assess the effects of the anesthetics on the perioperative cerebral oxygenation and cognitive functions in CEE.
Methods: The study and informed consent are approved by the Ethical Committee of the Northern State Medical University. Forty patients (males only) who are to undergo elective CEE will be included into a prospective study and randomised to two groups receiving either total intravenous anaesthesia (TIVA group, propofol + fentanyl) or the volatile induction and maintenance of anaesthesia (VIMA group, n = 20, sevoflurane + fentanyl). All patients were operated using temporary carotid bypass. Invasive arterial pressure (AP), gas exchange, and cerebral tissue oxygen saturation (SctO2, ForeSight, CAsMed, USA) over frontal region for ipsilateral (SctO2IPSI) and contralateral (SctO2CONTR) hemispheres were registered during the surgery and up to 20 hrs of the postoperative period. The cognitive changes will be assessed at 12 hrs before as well as on Days 1 and 5 after CEE by blinded investigator using Montreal Cognitive Assessment score (MoCA).
Data will be presented as median (25-75th percentiles). Intergroup comparison will be provided with Mann-Whitney U-test and correlation analysis with Spearman's coefficient (rho). P value below 0.05 was regarded as statistically significant.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arkhangelsk, Russian Federation, 163001
- City hospital # 1 / Northern State Medical University,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- > 18 years
- Male gender
- Informed consent
- Symptomatic carotid stenosis > 75%
Exclusion Criteria:
- Contralateral carotid occlusion
- Known allergy to the one of the compared medications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Sham Comparator: TIVA with propofol
Induction and maintenance of general anesthesia using TIVA with propofol
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Intravenous induction and maintenance of general anesthesia with propofol is a routine practice for this intervention
Other Names:
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Active Comparator: VIMA with sevoflurane
Induction and maintenance of general anesthesia using VIMA with sevoflurane
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Volatile induction and maintenance of general anesthesia with sevoflurane is a generally acceptable clinical approach for this intervention
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Early postoperative cognitive dysfunction
Time Frame: 5 Days of the perioperative period
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Postoperative cognitive dysfunction assessed with MoCA score
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5 Days of the perioperative period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cerebral desaturation
Time Frame: 0-20 hrs of the perioperative period
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Cerebral tissue oxygen saturation monitored intra- and postoperatively with non-invasive cerebral tissue oximeter
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0-20 hrs of the perioperative period
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Postoperative Complications
- Neurocognitive Disorders
- Cognition Disorders
- Cognitive Dysfunction
- Postoperative Cognitive Complications
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, Intravenous
- Anesthetics, General
- Platelet Aggregation Inhibitors
- Hypnotics and Sedatives
- Anesthetics, Inhalation
- Anesthetics
- Propofol
- Sevoflurane
Other Study ID Numbers
- CEE-VIMA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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