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
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Aneurysm||Drug: Stellate Ganglion Block||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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.
- 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.
- 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.
- 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).
- 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)
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
|General Hospital of Ningxia Medical University|
|Yinchuan, Ningxia, China, 750004|
|Principal Investigator:||Xu Wang||Gereral Hospital of Ningxia Medical University|