Back to resultsStellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage
Primary Purpose
Subarachnoid Hemorrhage, Aneurysmal, Cerebral Vasospasm
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stellate Ganglion Block
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Subarachnoid Hemorrhage, Aneurysmal focused on measuring Stellate Ganglion Block, Subarachnoid Hemorrhage, Cerebral Vasospasm, Transcranial Doppler Ultrasonography
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Stellate Ganglion Block
No Stellate Ganglion Block
Arm 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. Patients were then assessed using transcranial Doppler
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. Patients were then assessed using transcranial Doppler
Outcomes
Primary Outcome Measures
The incidence of cerebral vasospasm
Secondary Outcome Measures
Full Information
NCT ID
NCT04512859
First Posted
August 11, 2020
Last Updated
September 6, 2020
Sponsor
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04512859
Brief Title
Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage
Official Title
Effect of Stellate Ganglion Block on Cerebral Vasospasm in Patients With Emergency Aneurysmal Subarachnoid Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Aneurysmal, Cerebral Vasospasm
Keywords
Stellate Ganglion Block, Subarachnoid Hemorrhage, Cerebral Vasospasm, Transcranial Doppler Ultrasonography
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stellate Ganglion Block
Arm Type
Experimental
Arm 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.
Patients were then assessed using transcranial Doppler
Arm Title
No Stellate Ganglion Block
Arm Type
Placebo Comparator
Arm 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.
Patients were then assessed using transcranial Doppler
Intervention Type
Procedure
Intervention Name(s)
Stellate Ganglion Block
Intervention Description
Stellate ganglion block under ultra-guide will be administered using 0.25% ropivacaine 10mL
Intervention Type
Procedure
Intervention Name(s)
Placebo
Intervention Description
Stellate ganglion block under ultra-guide will be administered using 0.9% saline 10mL
Primary Outcome Measure Information:
Title
The incidence of cerebral vasospasm
Time Frame
Change from baseline at 5day,after subarachnoid hemorrhage
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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;
12. IPD Sharing Statement
Learn more about this trial
Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage
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