Clinical trial NCT02771418: The Effects of Anaesthesia on Cerebral Oxygenation and Cognitive Function in Carotid Endarterectomy
Official title: The Effects of Anaesthesia on Cerebral Oxygenation and Cognitive Function in Carotid Endarterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endarterectomy
Postoperative Cognitive Dysfunction
Keywords: Carotid endarterectomy
postoperative cognitive dysfunction
Lead sponsor: Northern State Medical University
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Early postoperative cognitive dysfunction
timeFrame: 5 Days of the perioperative period
Secondary outcomes:
measure: Cerebral desaturation
timeFrame: 0-20 hrs of the perioperative period
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: City hospital # 1 / Northern State Medical University,
Study officials:
References: