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Completed

NCT Number: NCT02771418

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

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.

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Key information

Conditions

Endarterectomy Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Cognitive Dysfunction Postoperative Complications

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

City hospital # 1 / Northern State Medical University,

Arkhangelsk, 163001, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

Intravenous induction and maintenance of general anesthesia with propofol is a routine practice for this intervention

Other names: Tital intravenous anesthesia (TIVA)

Sevoflurane

Drug

Volatile induction and maintenance of general anesthesia with sevoflurane is a generally acceptable clinical approach for this intervention

Other names: Volatile induction and maintenance of anesthesia (VIMA)

Elective carotid endarterectomy

Procedure

Primary outcomes

  1. Early postoperative cognitive dysfunction

    Time frame: 5 Days of the perioperative period

    Postoperative cognitive dysfunction assessed with MoCA score

Secondary outcomes

  1. Cerebral desaturation

    Time frame: 0-20 hrs of the perioperative period

    Cerebral tissue oxygen saturation monitored intra- and postoperatively with non-invasive cerebral tissue oximeter

Sponsors and collaborators

Lead sponsor

Northern State Medical University

Other

Registry information

Acronym: CEE-VIMA

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 13, 2016
Registry last updated
Sep 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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