Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-26 @ 1:31 PM
Study NCT ID:
NCT04512859
Status:
UNKNOWN
Last Update Posted:
2020-09-09
First Post:
2020-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D020301', 'term': 'Vasospasm, Intracranial'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'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'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-06', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-08-11', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of cerebral vasospasm', 'timeFrame': 'Change from baseline at 5day,after subarachnoid hemorrhage'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stellate Ganglion Block', 'Subarachnoid Hemorrhage', 'Cerebral Vasospasm', 'Transcranial Doppler Ultrasonography'], 'conditions': ['Subarachnoid Hemorrhage, Aneurysmal', 'Cerebral Vasospasm']}, 'descriptionModule': {'briefSummary': 'To investigate whether the stellate ganglion block is helpful in relieving cerebral vasospasm during aneurysmal coil embolism surgery. The effect was assessed by Transcranial Doppler (TCD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Emergency patients with subarachnoid hemorrhage caused by ruptured aneurysm, aged 18-65 years; 2. ASA : II-IV grade, Hunt-Hess : I-III grade 3. For the first case, the operation time is within 24 hours. 4.After signing informed consent, underwent interventional intravascular embolization\n\nExclusion Criteria:\n\n* 1\\. Patients with severe bleeding disorders; 2. Patients with trauma and local infection risk in the nerve block area; 3. Patients with previous aneurysm surgery and unruptured aneurysm; 4. Aneurysm located in middle cerebral artery; 5. Patients with unconsciousness cannot cooperate with the block operation; 6. Those with a history of mental illness and epilepsy; 7. Those who have a history of severe cardiovascular and cerebrovascular diseases and severe organ diseases;'}, 'identificationModule': {'nctId': 'NCT04512859', 'briefTitle': 'Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Effect of Stellate Ganglion Block on Cerebral Vasospasm in Patients With Emergency Aneurysmal Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': '20200630'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stellate Ganglion Block', 'description': 'Experimental patients will receive a stellate ganglion block with 0.25% ropivacaine 10mL on the same side of vasospasm at the level of the sixth cervical vertebrae (C6) before surgery.\n\nPatients were then assessed using transcranial Doppler', 'interventionNames': ['Procedure: Stellate Ganglion Block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No Stellate Ganglion Block', 'description': 'patients will receive a stellate ganglion block with 0.9% saline 10mL on the same side of vasospasm at the level of the sixth cervical vertebrae (C6) before surgery.\n\nPatients were then assessed using transcranial Doppler', 'interventionNames': ['Procedure: Placebo']}], 'interventions': [{'name': 'Stellate Ganglion Block', 'type': 'PROCEDURE', 'description': 'Stellate ganglion block under ultra-guide will be administered using 0.25% ropivacaine 10mL', 'armGroupLabels': ['Stellate Ganglion Block']}, {'name': 'Placebo', 'type': 'PROCEDURE', 'description': 'Stellate ganglion block under ultra-guide will be administered using 0.9% saline 10mL', 'armGroupLabels': ['No Stellate Ganglion Block']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Professor', 'investigatorFullName': 'Yuming Peng', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}