Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage

NCT04512859 | Unknown

• 1 other identifier: 20200630
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Subarachnoid Hemorrhage, Aneurysmal; Cerebral Vasospasm

Keywords

Stellate Ganglion Block; Subarachnoid Hemorrhage; Cerebral Vasospasm; Transcranial Doppler Ultrasonography

Outcome Measures

Primary Outcomes (1)

• The incidence of cerebral vasospasm

  Change from baseline at 5day,after subarachnoid hemorrhage

Study Arms (2)

Stellate Ganglion Block

EXPERIMENTAL

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

No Stellate Ganglion Block

PLACEBO COMPARATOR

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

Interventions

Stellate Ganglion Block PROCEDURE

Stellate ganglion block under ultra-guide will be administered using 0.25% ropivacaine 10mL

Stellate Ganglion Block

Placebo PROCEDURE

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

No Stellate Ganglion Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 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;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Vasospasm, Intracranial

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Professor

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 14, 2020
• Study Start: September 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 9, 2020

Record last verified: 2020-09