Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-01 @ 12:54 PM
Study NCT ID:
NCT01204268
Status:
UNKNOWN
Last Update Posted:
2010-09-20
First Post:
2010-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Neuroprotection of Sevoflurane Preconditioning on Intracranial Aneurysm Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002545', 'term': 'Brain Ischemia'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-09-16', 'studyFirstSubmitDate': '2010-09-15', 'studyFirstSubmitQcDate': '2010-09-15', 'lastUpdatePostDateStruct': {'date': '2010-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'S-100B,NSE', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Karnofsky Performance Scale,NIH stroke index, MMSE', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cerebral ischemia', 'sevoflurane preconditioning', 'intracranial aneurysm surgery'], 'conditions': ['Brain Ischemia']}, 'descriptionModule': {'briefSummary': 'The current study is designed to clarify the neuroprotective effect of sevoflurane preconditioning on the patients underwent intracranial aneurysm surgery.', 'detailedDescription': 'The current study is designed to clarify the neuroprotective effect of sevoflurane preconditioning on the patients underwent intracranial aneurysm surgery. The patients with cerebral aneurysm will be recruited in current study. The sevoflurane preconditioning will be performed before the surgical procedure. The neurological injury biomarkers, such as S-100b and NSE will be detected. The neurological function and recovery will be assessed after the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient under intracranial aneurysm surgery.\n\nExclusion Criteria:\n\n* Patients who refused to participate or who had a history of chemotherapy/convulsions two weeks prior to admission, stroke/cardiopulmonary resuscitation/head trauma three months prior to admission, Alzheimer's disease, amyotrophic lateral sclerosis, and prior melanoma were excluded."}, 'identificationModule': {'nctId': 'NCT01204268', 'briefTitle': 'The Neuroprotection of Sevoflurane Preconditioning on Intracranial Aneurysm Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'The Neuroprotection of Sevoflurane Preconditioning on Perioperative Ischemia-reperfusion Injury During Intracranial Aneurysm Surgery', 'orgStudyIdInfo': {'id': 'APC-BRAIN-2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Propofol group', 'description': 'Patients will receive the total intravenous anesthesia with propofol infusion during the surgery.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sevo-C group', 'description': 'Patients will receive the anesthesia with continuous inhalation of sevoflurane.', 'interventionNames': ['Procedure: Sevo continuous inhalation']}, {'type': 'EXPERIMENTAL', 'label': 'Sevo-I group', 'description': 'Sevoflurane will be given before the cerebral artery clip as a preconditioning procedure for the coming ischemia-reperfusion injury.', 'interventionNames': ['Procedure: Sev-I group']}], 'interventions': [{'name': 'Sev-I group', 'type': 'PROCEDURE', 'otherNames': ['Sevoflurane preconditioning'], 'description': 'Sevoflurane will be given before the cerebral artery clip as a preconditioning procedure for the coming ischemia-reperfusion injury.', 'armGroupLabels': ['Sevo-I group']}, {'name': 'Sevo continuous inhalation', 'type': 'PROCEDURE', 'description': 'Patients will receive the anesthesia with continuous inhalation of sevoflurane.', 'armGroupLabels': ['Sevo-C group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lize Xiong, MD,PhD', 'role': 'CONTACT', 'email': 'lxiong@fmmu.edu.cn', 'phone': '86-2984775337'}], 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Hailong Dong, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xijing Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Hailong Dong', 'oldOrganization': 'Xijing Hospital, Fourth Military Medical University'}}}}