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Perioperative Neuroprotection of Stellate Ganglion Block

Primary Purpose

Intracranial Aneurysm

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stellate Ganglion Block
Sponsored by
General Hospital of Ningxia Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intracranial Aneurysm focused on measuring Stellate ganglion block, Aneurysm surgery, Cognitive recovery, Cerebral vasospasm

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General Hospital of Ningxia Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention 'Stellate Ganglion Block'

without 'Stellate Ganglion Block'

Arm Description

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.

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

Outcomes

Primary Outcome Measures

The incidence of cerebral vasospasm
The occurrence of cerebral vasospasm will be diagnosed by using of the transcranial doppler instrument.

Secondary Outcome Measures

Perioperative cerebral oxygen metabolism
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.
The difference of plasma endothelin, melatonin, and S100-β protein level between two groups at each time point
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.
Postoperative cognitive function
The postoperative cognitive function will be measured by using of the mini-mental state examination (MMSE).

Full Information

First Posted
October 20, 2014
Last Updated
May 19, 2016
Sponsor
General Hospital of Ningxia Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02275247
Brief Title
Perioperative Neuroprotection of Stellate Ganglion Block
Official Title
Preventive Effect of Stellate Ganglion Block on Cerebral Vasospasm in Patients Undergoing Aneurysm Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Hospital of Ningxia Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm
Keywords
Stellate ganglion block, Aneurysm surgery, Cognitive recovery, Cerebral vasospasm

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention 'Stellate Ganglion Block'
Arm Type
Experimental
Arm Description
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.
Arm Title
without 'Stellate Ganglion Block'
Arm Type
No Intervention
Arm Description
In the control group, every thing will be conducted as a matter of routine without intervention.
Intervention Type
Drug
Intervention Name(s)
Stellate Ganglion Block
Other Intervention Name(s)
Local anesthesia with low concentration ropivacaine
Intervention Description
stellate ganglion block will be administered using either 6-8mL saline (Group 1) or 0.25% ropivacaine 6-8mL (Group 2)
Primary Outcome Measure Information:
Title
The incidence of cerebral vasospasm
Description
The occurrence of cerebral vasospasm will be diagnosed by using of the transcranial doppler instrument.
Time Frame
Change from baseline at 2hour,6hour,1day,3day,and 7day after aneurysm surgery
Secondary Outcome Measure Information:
Title
Perioperative cerebral oxygen metabolism
Description
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.
Time Frame
Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively
Title
The difference of plasma endothelin, melatonin, and S100-β protein level between two groups at each time point
Description
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.
Time Frame
Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively
Title
Postoperative cognitive function
Description
The postoperative cognitive function will be measured by using of the mini-mental state examination (MMSE).
Time Frame
Change from baseline at 2hour,6hour,1day,3day,and 7day after aneurysm surgery
Other Pre-specified Outcome Measures:
Title
The postoperative recovery quality
Description
The postoperative recovery quality will be evaluated by using of the Post-operative Quality Recovery Scale (PQRS)
Time Frame
Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu Wang
Organizational Affiliation
Gereral Hospital of Ningxia Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China

12. IPD Sharing Statement

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Perioperative Neuroprotection of Stellate Ganglion Block

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