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Clinical Trials/NCT02771418
NCT02771418
Completed
Not Applicable

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

Northern State Medical University1 site in 1 country40 target enrollmentFebruary 2015

Overview

Phase
Not Applicable
Intervention
Propofol
Conditions
Endarterectomy
Sponsor
Northern State Medical University
Enrollment
40
Locations
1
Primary Endpoint
Early postoperative cognitive dysfunction
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
June 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Northern State Medical University
Responsible Party
Principal Investigator
Principal Investigator

Vsevolod V. Kuzkov

MD, PhD

Northern State Medical University

Eligibility Criteria

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

Arms & Interventions

TIVA with propofol

Induction and maintenance of general anesthesia using TIVA with propofol

Intervention: Propofol

TIVA with propofol

Induction and maintenance of general anesthesia using TIVA with propofol

Intervention: Elective carotid endarterectomy

VIMA with sevoflurane

Induction and maintenance of general anesthesia using VIMA with sevoflurane

Intervention: Sevoflurane

VIMA with sevoflurane

Induction and maintenance of general anesthesia using VIMA with sevoflurane

Intervention: Elective carotid endarterectomy

Outcomes

Primary Outcomes

Early postoperative cognitive dysfunction

Time Frame: 5 Days of the perioperative period

Postoperative cognitive dysfunction assessed with MoCA score

Secondary Outcomes

  • Cerebral desaturation(0-20 hrs of the perioperative period)

Study Sites (1)

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