The Effects of Anaesthesia on Cerebral Oxygenation and Cognitive Function in Carotid Endarterectomy

Study Overview
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Brief Summary
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Volatile anesthetics interfere with cerebral blood flow and reperfusion-ischemia injury via the mechanism known as a preconditioning. A transient deterioration of local hemodynamics and oxygenation during carotid endarterectomy (CEE) might involve both hemispheres of brain and affect postoperative cognitive function. The goal of this study was to assess the effects of anesthetics on perioperative cerebral oxygenation and cognitive functions.

Detailed Description
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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.

Official Title
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The Effects of Anaesthesia on Cerebral Oxygenation and Cognitive Function in Carotid Endarterectomy

Conditions
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Endarterectomy, Postoperative Cognitive Dysfunction

Intervention / Treatment
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* Drug: Propofol
* Drug: Sevoflurane
* Procedure: Elective carotid endarterectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: TIVA with propofol<br>Induction and maintenance of general anesthesia using TIVA with propofol | Drug: Propofol<br>* Intravenous induction and maintenance of general anesthesia with propofol is a routine practice for this intervention<br>* Other names: Tital intravenous anesthesia (TIVA);Procedure: Elective carotid endarterectomy<br> <br> |
| Active Comparator: VIMA with sevoflurane<br>Induction and maintenance of general anesthesia using VIMA with sevoflurane | Drug: Sevoflurane<br>* Volatile induction and maintenance of general anesthesia with sevoflurane is a generally acceptable clinical approach for this intervention<br>* Other names: Volatile induction and maintenance of anesthesia (VIMA);Procedure: Elective carotid endarterectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early postoperative cognitive dysfunction | Postoperative cognitive dysfunction assessed with MoCA score | 5 Days of the perioperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral desaturation | Cerebral tissue oxygen saturation monitored intra- and postoperatively with non-invasive cerebral tissue oximeter | 0-20 hrs of the perioperative period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carotid endarterectomy, postoperative cognitive dysfunction