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Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage

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ClinicalTrials.gov Identifier: NCT04512859
Recruitment Status : Not yet recruiting
First Posted : August 14, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Yuming Peng, Beijing Tiantan Hospital

Study Description
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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).

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage, Aneurysmal Cerebral Vasospasm Procedure: Stellate Ganglion Block Procedure: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Stellate Ganglion Block on Cerebral Vasospasm in Patients With Emergency Aneurysmal Subarachnoid Hemorrhage
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Experimental: Stellate Ganglion Block

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

 Procedure: Stellate Ganglion Block
Stellate ganglion block under ultra-guide will be administered using 0.25% ropivacaine 10mL
Placebo Comparator: No Stellate Ganglion Block

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

 Procedure: Placebo
Stellate ganglion block under ultra-guide will be administered using 0.9% saline 10mL


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of cerebral vasospasm [ Time Frame: Change from baseline at 5day,after subarachnoid hemorrhage ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Yuming Peng, Vice Professor, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT04512859    
Other Study ID Numbers: 20200630
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yuming Peng, Beijing Tiantan Hospital:
Stellate Ganglion Block
Subarachnoid Hemorrhage
Cerebral Vasospasm
Transcranial Doppler Ultrasonography
Additional relevant MeSH terms:
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Ganglion Cysts
Subarachnoid Hemorrhage
Vasospasm, Intracranial
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases