Perioperative Neuroprotection of Stellate Ganglion Block

NCT ID: NCT02275247

Last Updated: 2016-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-10-31

Brief Summary

To investigate whether stellate ganglion block is helpful to brain protection during cranial aneurysm surgery

Detailed Description

The vasospasm after cranial aneurysm surgery have a higher incidence, but not have an ideal treatment method. At present, the medical treatment is very limited effect to prevent the perioperative cerebral ischemia.Stellate ganglion block （SGB）is an effective and well-tolerated approach to the treatment of CVS in various clinical settings.Resent study indicated that SGB has a protective effect on delayed cerebral vasospasm in an experimental rat model of subarachnoid hemorrhage.Therefore,we hypothesized that the preoperative SGB would be a effective treatment for improvement of vasospasm after cranial aneurysm surgery.

Conditions

Intracranial Aneurysm

Study Design

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

Study Groups

Intervention 'Stellate Ganglion Block'

Experimental patients will receive a stellate ganglion block with 0.25% ropivacaine 6-8mL on the right side at the level of the sixth cervical vertebrae (C6) before surgery.Then the catheter will be attached to a single use patient-controlled analgesia pump containing 0.2% ropivacaine 150 mL, which will be infused at 2 mL/h.

Group Type: EXPERIMENTAL

Stellate Ganglion Block

Intervention Type: DRUG

stellate ganglion block will be administered using either 6-8mL saline (Group 1) or 0.25% ropivacaine 6-8mL (Group 2)

without 'Stellate Ganglion Block'

In the control group, every thing will be conducted as a matter of routine without intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Stellate Ganglion Block

stellate ganglion block will be administered using either 6-8mL saline (Group 1) or 0.25% ropivacaine 6-8mL (Group 2)

Intervention Type: DRUG

Other Intervention Names

Local anesthesia with low concentration ropivacaine

Eligibility Criteria

Inclusion Criteria

• aneurysm subarachnoid hemorrhage patients scheduled for cranial aneurysm surgery，
• ASA grade：Ⅱ-Ⅲ，
• Hunt～Hess grade :Ⅰ-Ⅲ,
• have a informed consent.

Exclusion Criteria

• history of mental illness，
• local infection who can't do stellate ganglion block，
• pregnant or lactating，
• nausea cancer or diabetes，
• participated the study or other related research in the last 30 days，
• unruptured aneurysms patients

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Ningxia Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xu Wang

Role: PRINCIPAL_INVESTIGATOR

Gereral Hospital of Ningxia Medical University

Locations

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Countries

China

Other Identifiers

NXKJGG2014

Identifier Type: -

Identifier Source: org_study_id