Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04512859

Collaborator

(none)

160

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Subarachnoid Hemorrhage, Aneurysmal Cerebral Vasospasm	Procedure: Stellate Ganglion Block Procedure: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Primary Outcome Measures

The incidence of cerebral vasospasm [Change from baseline at 5day,after subarachnoid hemorrhage]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;