Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-25 @ 11:14 PM
Study NCT ID:
NCT06666959
Status:
COMPLETED
Last Update Posted:
2024-10-31
First Post:
2024-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sevoflurane Versus Propofol in Endovascular Coiling of Cerebral Aneurysm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-28', 'studyFirstSubmitDate': '2024-10-26', 'studyFirstSubmitQcDate': '2024-10-28', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of interleukin-10', 'timeFrame': 'From enrollment to 3 months postoperation', 'description': 'Test the concentration of interleukin-10 of the participants'}], 'secondaryOutcomes': [{'measure': 'Concentration of interleukin-1', 'timeFrame': 'From enrollment to 3 months postoperation', 'description': 'Test the Concentration of interleukin-1 in participants'}, {'measure': 'Concentration of interleukin-2', 'timeFrame': 'From enrollment to 3 months postoperation', 'description': 'Test the concentration of interleukin-2 in participants'}, {'measure': 'Concentration of interleukin-6', 'timeFrame': 'From enrollment to 3 months postoperation', 'description': 'Test the concentration of interleukin-6 in participants'}, {'measure': 'Concentration of interleukin-8', 'timeFrame': 'From enrollment to 3 months postoperation', 'description': 'Test the concentration of interleukin-8 in participants'}, {'measure': 'Concentration of tumor necrosis factor', 'timeFrame': 'From enrollment to 3 months postoperation', 'description': 'Test the concentration of tumor necrosis factor in participants'}, {'measure': 'Concentration of S100B', 'timeFrame': 'From enrollment to 3 months postoperation', 'description': 'Test the concentration of S100B in participants'}, {'measure': 'length of stay', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'The time from admission to discharge'}, {'measure': 'costs', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Hospitalization expenses'}, {'measure': 'Glasgow Coma Score', 'timeFrame': 'From enrollment to 3 months postoperation', 'description': 'The scores are ranging from 3 to 15. And higher scores mean a betterr outcome .'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Propofol', 'Sevoflurane']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the anti-inflammatory effects of anesthetics on patients undergoing endovascular coiling of cerebral aneurysm. The main question it aims to answer is:\n\nDoes sevoflurane or propofol affect the inflammatory response in subarachnoid hemorrhage?\n\nParticipants already undergoing endovascular coiling of cerebral aneurysm will have their serum levels of inflammatory factors measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In Tongji hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive patients aged 18 years and older presenting to the Tongji hospital for endovascular coiling of cerebral aneurysm were eligible for enrollment.\n\nExclusion Criteria:\n\n* have an endocrine system disease\n* pregnancy\n* have other brain disorders\n* take drugs that alter endocrine hormones\n* receive perioperative blood derivatives'}, 'identificationModule': {'nctId': 'NCT06666959', 'briefTitle': 'Sevoflurane Versus Propofol in Endovascular Coiling of Cerebral Aneurysm', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Comparison of the Neuroprotective Effect of Sevoflurane Versus Propofol in Patients Undergoing Endovascular Coiling of Cerebral Aneurysm', 'orgStudyIdInfo': {'id': 'TJ-IRB20230413'}, 'secondaryIdInfos': [{'id': 'SW-001', 'type': 'OTHER', 'domain': 'department of neurosurgery in Tongji hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients undergoing endovascular coiling of cerebral aneurysm in Tongji hospital', 'description': 'The present clinical study was carried out with the aim of determine whether the inflammatory effect differs when using propofol or sevoflurane anesthesia.', 'interventionNames': ['Drug: Anesthesia Agent']}], 'interventions': [{'name': 'Anesthesia Agent', 'type': 'DRUG', 'otherNames': ['sevoflurane', 'propofol'], 'description': 'intravenous anesthetic and inhalation anesthetic', 'armGroupLabels': ['patients undergoing endovascular coiling of cerebral aneurysm in Tongji hospital']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Department of Neurosurgery', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'mingxin zhu', 'investigatorAffiliation': 'Tongji Hospital'}}}}