ClinicalTrials.Veeva

Menu

The Effects of Anaesthesia on Cerebral Oxygenation and Cognitive Function in Carotid Endarterectomy (CEE-VIMA)

N

Northern State Medical University

Status

Completed

Conditions

Endarterectomy
Postoperative Cognitive Dysfunction

Treatments

Procedure: Elective carotid endarterectomy
Drug: Propofol
Drug: Sevoflurane

Study type

Interventional

Funder types

Other

Identifiers

NCT02771418
CEE-VIMA

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

TIVA with propofol
Sham Comparator group
Description:
Induction and maintenance of general anesthesia using TIVA with propofol
Treatment:
Procedure: Elective carotid endarterectomy
Drug: Propofol
VIMA with sevoflurane
Active Comparator group
Description:
Induction and maintenance of general anesthesia using VIMA with sevoflurane
Treatment:
Procedure: Elective carotid endarterectomy
Drug: Sevoflurane

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems