Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-03-12 @ 6:25 AM
Study NCT ID:
NCT02771418
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2016-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Anaesthesia on Cerebral Oxygenation and Cognitive Function in Carotid Endarterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-21', 'studyFirstSubmitDate': '2016-05-06', 'studyFirstSubmitQcDate': '2016-05-11', 'lastUpdatePostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early postoperative cognitive dysfunction', 'timeFrame': '5 Days of the perioperative period', 'description': 'Postoperative cognitive dysfunction assessed with MoCA score'}], 'secondaryOutcomes': [{'measure': 'Cerebral desaturation', 'timeFrame': '0-20 hrs of the perioperative period', 'description': 'Cerebral tissue oxygen saturation monitored intra- and postoperatively with non-invasive cerebral tissue oximeter'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Carotid endarterectomy', 'postoperative cognitive dysfunction'], 'conditions': ['Endarterectomy', 'Postoperative Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nMethods: 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).\n\nData 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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years\n* Male gender\n* Informed consent\n* Symptomatic carotid stenosis \\> 75%\n\nExclusion Criteria:\n\n* Contralateral carotid occlusion\n* Known allergy to the one of the compared medications'}, 'identificationModule': {'nctId': 'NCT02771418', 'acronym': 'CEE-VIMA', 'briefTitle': 'The Effects of Anaesthesia on Cerebral Oxygenation and Cognitive Function in Carotid Endarterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Northern State Medical University'}, 'officialTitle': 'The Effects of Anaesthesia on Cerebral Oxygenation and Cognitive Function in Carotid Endarterectomy', 'orgStudyIdInfo': {'id': 'CEE-VIMA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'TIVA with propofol', 'description': 'Induction and maintenance of general anesthesia using TIVA with propofol', 'interventionNames': ['Drug: Propofol', 'Procedure: Elective carotid endarterectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VIMA with sevoflurane', 'description': 'Induction and maintenance of general anesthesia using VIMA with sevoflurane', 'interventionNames': ['Drug: Sevoflurane', 'Procedure: Elective carotid endarterectomy']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Tital intravenous anesthesia (TIVA)'], 'description': 'Intravenous induction and maintenance of general anesthesia with propofol is a routine practice for this intervention', 'armGroupLabels': ['TIVA with propofol']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Volatile induction and maintenance of anesthesia (VIMA)'], 'description': 'Volatile induction and maintenance of general anesthesia with sevoflurane is a generally acceptable clinical approach for this intervention', 'armGroupLabels': ['VIMA with sevoflurane']}, {'name': 'Elective carotid endarterectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['TIVA with propofol', 'VIMA with sevoflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '163001', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'City hospital # 1 / Northern State Medical University,', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Will be published in the peer-reviewed journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northern State Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Vsevolod V. Kuzkov', 'investigatorAffiliation': 'Northern State Medical University'}}}}