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

NCT02771418 | Completed

• 1 other identifier: CEE-VIMA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Endarterectomy; Postoperative Cognitive Dysfunction

Keywords

Carotid endarterectomy; postoperative cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

• Early postoperative cognitive dysfunction

  Postoperative cognitive dysfunction assessed with MoCA score

  5 Days of the perioperative period

Secondary Outcomes (1)

• Cerebral desaturation

  0-20 hrs of the perioperative period

Study Arms (2)

TIVA with propofol

SHAM COMPARATOR

Induction and maintenance of general anesthesia using TIVA with propofol

Drug: Propofol; Procedure: Elective carotid endarterectomy

VIMA with sevoflurane

ACTIVE COMPARATOR

Induction and maintenance of general anesthesia using VIMA with sevoflurane

Drug: Sevoflurane; Procedure: Elective carotid endarterectomy

Interventions

Propofol DRUG

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

Also known as: Tital intravenous anesthesia (TIVA)

TIVA with propofol

Sevoflurane DRUG

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

Also known as: Volatile induction and maintenance of anesthesia (VIMA)

VIMA with sevoflurane

Elective carotid endarterectomy PROCEDURE

TIVA with propofol; VIMA with sevoflurane

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years
• Male gender
• Informed consent
• Symptomatic carotid stenosis \> 75%

You may not qualify if:

• Contralateral carotid occlusion
• Known allergy to the one of the compared medications

Sponsors & Collaborators

• Northern State Medical University: lead

Study Sites (1)

City hospital # 1 / Northern State Medical University,

Arkhangelsk, 163001, Russia

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 13, 2016
• Study Start: February 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 22, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

RU (1)