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Perioperative Neuroprotection of Stellate Ganglion Block

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ClinicalTrials.gov Identifier: NCT02275247
Recruitment Status : Unknown
Verified May 2016 by General Hospital of Ningxia Medical University.
Recruitment status was:  Enrolling by invitation
First Posted : October 27, 2014
Last Update Posted : May 20, 2016
Sponsor:
Information provided by (Responsible Party):
General Hospital of Ningxia Medical University

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

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Drug: Stellate Ganglion Block Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Preventive Effect of Stellate Ganglion Block on Cerebral Vasospasm in Patients Undergoing Aneurysm Surgery
Study Start Date : August 2014
Actual Primary Completion Date : October 2015
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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 Name: 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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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).


Other Outcome Measures:
  1. 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)



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275247


Locations
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China, Ningxia
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China, 750004
Sponsors and Collaborators
General Hospital of Ningxia Medical University
Investigators
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Principal Investigator: Xu Wang Gereral Hospital of Ningxia Medical University

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Responsible Party: General Hospital of Ningxia Medical University
ClinicalTrials.gov Identifier: NCT02275247     History of Changes
Other Study ID Numbers: NXKJGG2014
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: May 20, 2016
Last Verified: May 2016

Keywords provided by General Hospital of Ningxia Medical University:
Stellate ganglion block
Aneurysm surgery
Cognitive recovery
Cerebral vasospasm

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Ganglion Cysts
Vasospasm, Intracranial
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents