The Effects of Anaesthesia on Cerebral Oxygenation and Cognitive Function in Carotid Endarterectomy (CEE-VIMA)
Primary Purpose
Endarterectomy, Postoperative Cognitive Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Propofol
Sevoflurane
Elective carotid endarterectomy
Sponsored by
About this trial
This is an interventional supportive care trial for Endarterectomy focused on measuring Carotid endarterectomy, postoperative cognitive dysfunction
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
Sites / Locations
- City hospital # 1 / Northern State Medical University,
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
TIVA with propofol
VIMA with sevoflurane
Arm Description
Induction and maintenance of general anesthesia using TIVA with propofol
Induction and maintenance of general anesthesia using VIMA with sevoflurane
Outcomes
Primary Outcome Measures
Early postoperative cognitive dysfunction
Postoperative cognitive dysfunction assessed with MoCA score
Secondary Outcome Measures
Cerebral desaturation
Cerebral tissue oxygen saturation monitored intra- and postoperatively with non-invasive cerebral tissue oximeter
Full Information
NCT ID
NCT02771418
First Posted
May 6, 2016
Last Updated
September 21, 2016
Sponsor
Northern State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02771418
Brief Title
The Effects of Anaesthesia on Cerebral Oxygenation and Cognitive Function in Carotid Endarterectomy
Acronym
CEE-VIMA
Official Title
The Effects of Anaesthesia on Cerebral Oxygenation and Cognitive Function in Carotid Endarterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northern State Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endarterectomy, Postoperative Cognitive Dysfunction
Keywords
Carotid endarterectomy, postoperative cognitive dysfunction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TIVA with propofol
Arm Type
Sham Comparator
Arm Description
Induction and maintenance of general anesthesia using TIVA with propofol
Arm Title
VIMA with sevoflurane
Arm Type
Active Comparator
Arm Description
Induction and maintenance of general anesthesia using VIMA with sevoflurane
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Tital intravenous anesthesia (TIVA)
Intervention Description
Intravenous induction and maintenance of general anesthesia with propofol is a routine practice for this intervention
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Volatile induction and maintenance of anesthesia (VIMA)
Intervention Description
Volatile induction and maintenance of general anesthesia with sevoflurane is a generally acceptable clinical approach for this intervention
Intervention Type
Procedure
Intervention Name(s)
Elective carotid endarterectomy
Primary Outcome Measure Information:
Title
Early postoperative cognitive dysfunction
Description
Postoperative cognitive dysfunction assessed with MoCA score
Time Frame
5 Days of the perioperative period
Secondary Outcome Measure Information:
Title
Cerebral desaturation
Description
Cerebral tissue oxygen saturation monitored intra- and postoperatively with non-invasive cerebral tissue oximeter
Time Frame
0-20 hrs of the perioperative period
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
City hospital # 1 / Northern State Medical University,
City
Arkhangelsk
ZIP/Postal Code
163001
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Will be published in the peer-reviewed journal
Learn more about this trial
The Effects of Anaesthesia on Cerebral Oxygenation and Cognitive Function in Carotid Endarterectomy
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