The Effects of Anaesthesia on Cerebral Oxygenation and Cognitive Function in Carotid Endarterectomy
NCT ID: NCT02771418
Last Updated: 2016-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2015-02-28
2016-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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TIVA with propofol
Induction and maintenance of general anesthesia using TIVA with propofol
Propofol
Intravenous induction and maintenance of general anesthesia with propofol is a routine practice for this intervention
Elective carotid endarterectomy
VIMA with sevoflurane
Induction and maintenance of general anesthesia using VIMA with sevoflurane
Sevoflurane
Volatile induction and maintenance of general anesthesia with sevoflurane is a generally acceptable clinical approach for this intervention
Elective carotid endarterectomy
Interventions
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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
Elective carotid endarterectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male gender
* Informed consent
* Symptomatic carotid stenosis \> 75%
Exclusion Criteria
* Known allergy to the one of the compared medications
18 Years
MALE
No
Sponsors
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Northern State Medical University
OTHER
Responsible Party
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Vsevolod V. Kuzkov
MD, PhD
Locations
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City hospital # 1 / Northern State Medical University,
Arkhangelsk, , Russia
Countries
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Other Identifiers
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CEE-VIMA
Identifier Type: -
Identifier Source: org_study_id
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