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

Postoperative Cognitive Dysfunction Clinical Trial

— CEE-VIMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02771418
• Other study ID #: CEE-VIMA
• Status: Completed
• Phase: N/A
• First received: May 6, 2016
• Last updated: September 21, 2016
• Start date: February 2015
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Northern State Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cognition Disorders
• Endarterectomy
• Postoperative Cognitive Dysfunction

Intervention

Drug:
• Propofol
Intravenous induction and maintenance of general anesthesia with propofol is a routine practice for this intervention
• Sevoflurane
Volatile induction and maintenance of general anesthesia with sevoflurane is a generally acceptable clinical approach for this intervention

Procedure:
• Elective carotid endarterectomy

Locations

Country	Name	City	State
Russian Federation	City hospital # 1 / Northern State Medical University,	Arkhangelsk

Sponsors (1)

Lead Sponsor	Collaborator
Northern State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early postoperative cognitive dysfunction	Postoperative cognitive dysfunction assessed with MoCA score	5 Days of the perioperative period	No
Secondary	Cerebral desaturation	Cerebral tissue oxygen saturation monitored intra- and postoperatively with non-invasive cerebral tissue oximeter	0-20 hrs of the perioperative period	No