Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage

NCT ID: NCT04512859

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Stellate Ganglion Block

Intervention Type: PROCEDURE

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: PROCEDURE

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

Interventions

Stellate Ganglion Block

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

Intervention Type: PROCEDURE

Placebo

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

Intervention Type: PROCEDURE

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yuming Peng

Vice Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

20200630

Identifier Type: -

Identifier Source: org_study_id