Perioperative Neuroprotection of Stellate Ganglion Block

Intracranial Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02275247
• Other study ID #: NXKJGG2014
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 20, 2014
• Last updated: May 19, 2016
• Start date: August 2014
• Est. completion date: October 2016

Study information

• Verified date: May 2016
• Source: General Hospital of Ningxia Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: October 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• aneurysm subarachnoid hemorrhage patients scheduled for cranial aneurysm surgery,

• ASA grade:?-?,

• Hunt~Hess grade :?-?,

• 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

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)

Locations

Country	Name	City	State
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The postoperative recovery quality	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	Yes
Primary	The incidence of cerebral vasospasm	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	Yes
Secondary	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.	Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively	Yes
Secondary	The difference of plasma endothelin, melatonin, and S100-ß 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-ß protein will be measured using enzyme-linked immunosorbent assays.	Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively	Yes
Secondary	Postoperative cognitive function	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	Yes