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Status unknownNCT02275247Updated May 20, 2016

Perioperative Neuroprotection of Stellate Ganglion Block

An interventional study of Stellate Ganglion Block in Intracranial Aneurysm, sponsored by General Hospital of Ningxia Medical University. Status unknown at 1 site in China. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-05-20.

Sponsored by General Hospital of Ningxia Medical University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Intracranial Aneurysm

Keywords

  • Stellate ganglion block
  • Aneurysm surgery
  • Cognitive recovery
  • Cerebral vasospasm
03

In context

Ganglion Cysts

136 studies on the registry are indexed under Ganglion Cysts; 28 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 101 interventional studies indexed under Ganglion Cysts.

Browse Ganglion Cysts studies →

Lead sponsor

General Hospital of Ningxia Medical University is the lead sponsor of 102 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • No intervention
    without 'Stellate Ganglion Block'

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

Interventions

  • DrugStellate Ganglion Block

    stellate ganglion block will be administered using either 6-8mL saline (Group 1) or 0.25% ropivacaine 6-8mL (Group 2)

    Also known as: Local anesthesia with low concentration ropivacaine

06

What researchers measure

Primary outcomes

  1. The incidence of cerebral vasospasm

    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 outcomes

  1. 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.

    Time frame: Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively

  2. 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.

    Time frame: Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively

  3. Postoperative cognitive function

    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 outcomes

  1. The postoperative recovery quality

    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

07

Study locations

1 site
  • General Hospital of Ningxia Medical University
    Yinchuan, Ningxia 750004, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02275247
Lead sponsor
General Hospital of Ningxia Medical University
Responsible party
Sponsor
First posted
Oct 27, 2014
Start date
Aug 2014
Primary completion
Oct 2015
Completion
Oct 2016 (estimated)
Last update
May 20, 2016

Study contacts

Xu Wang
principal investigator · Gereral Hospital of Ningxia Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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