Perioperative Neuroprotection of Stellate Ganglion Block

May 19, 2016 updated by: General Hospital of Ningxia Medical University

Preventive Effect of Stellate Ganglion Block on Cerebral Vasospasm in Patients Undergoing Aneurysm Surgery

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • General Hospital of Ningxia Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Stellate Ganglion Block
stellate ganglion block will be administered using either 6-8mL saline (Group 1) or 0.25% ropivacaine 6-8mL (Group 2)
Other Names:
  • Local anesthesia with low concentration ropivacaine
No Intervention: without 'Stellate Ganglion Block'
In the control group, every thing will be conducted as a matter of routine without intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of cerebral vasospasm
Time Frame: Change from baseline at 2hour,6hour,1day,3day,and 7day after aneurysm surgery
The occurrence of cerebral vasospasm will be diagnosed by using of the transcranial doppler instrument.
Change from baseline at 2hour,6hour,1day,3day,and 7day after aneurysm surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative cerebral oxygen metabolism
Time Frame: Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively

Cerebral oxygen metabolism will be monitored through jugular venous oxygen saturation (SjVO2) and cerebral extraction rate of oxygen (CERO2), and measured by blood gas analysis at each time point, the latter will be calculated using the formula:

CaO2 = (Hb*1.38*SaO2) + (0.003*PaO2); CvO2 = (Hb*1.38*SjvO2) + (0.003*PjvO2); CERO2 = (CaO2-CvO2)/CaO2 where CaO2 is arterial oxygen content, Hb is arterial hemoglobin concentration, SaO2 is arterial oxygen saturation, PaO2 is the arterial partial pressure of oxygen, CvO2 is mixed venous oxygen content and PjvO2 is the jugular venous partial pressure of oxygen.
Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively
The difference of plasma endothelin, melatonin, and S100-β protein level between two groups at each time point
Time Frame: Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively
A 5-mL jugular venous blood sample will be taken at each time point, centrifuged at 3,000 rpm for 25 min, and kept in a freezer at -80°C until analysis. the concentrations of plasma endothelin, melatonin, and S100-β protein will be measured using enzyme-linked immunosorbent assays.
Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively
Postoperative cognitive function
Time Frame: Change from baseline at 2hour,6hour,1day,3day,and 7day after aneurysm surgery
The postoperative cognitive function will be measured by using of the mini-mental state examination (MMSE).
Change from baseline at 2hour,6hour,1day,3day,and 7day after aneurysm surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The postoperative recovery quality
Time Frame: Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively
The postoperative recovery quality will be evaluated by using of the Post-operative Quality Recovery Scale (PQRS)
Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Ningxia Medical University

Investigators

  • Principal Investigator: Xu Wang, Gereral Hospital of Ningxia Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

October 20, 2014

First Submitted That Met QC Criteria

October 24, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Estimate)

May 20, 2016

Last Update Submitted That Met QC Criteria

May 19, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NXKJGG2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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