Intracranial AneurysmNCT02275247
Perioperative Neuroprotection of Stellate Ganglion Block
A study testing Stellate Ganglion Block in people with Intracranial Aneurysm, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
To investigate whether stellate ganglion block is helpful to brain protection during cranial aneurysm surgery Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Stellate Ganglion Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aneurysm subarachnoid hemorrhage patients scheduled for cranial aneurysm surgery，
- ASA grade：Ⅱ-Ⅲ，
- Hunt～Hess grade :Ⅰ-Ⅲ,
- have a informed consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
About this study
Official title: Preventive Effect of Stellate Ganglion Block on Cerebral Vasospasm in Patients Undergoing Aneurysm Surgery
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.
- Conditions
- Intracranial Aneurysm
- Being tested
- Stellate Ganglion Block
- Keywords
- Stellate ganglion block, Aneurysm surgery, Cognitive recovery, Cerebral vasospasm
- Medical subject headings
- Intracranial Aneurysm, Vasospasm, Intracranial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate Ganglion BlockDrug
Also called Local anesthesia with low concentration ropivacaine
stellate ganglion block will be administered using either 6-8mL saline (Group 1) or 0.25% ropivacaine 6-8mL (Group 2)
| Study group | Role | What they receive |
|---|---|---|
| Intervention 'Stellate Ganglion Block' | Experimental | 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. Receives: Drug: Stellate Ganglion Block |
| without 'Stellate Ganglion Block' | No intervention | In the control group, every thing will be conducted as a matter of routine without intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of cerebral vasospasm
The occurrence of cerebral vasospasm will be diagnosed by using of the transcranial doppler instrument.
Measured: Change from baseline at 2hour,6hour,1day,3day,and 7day after aneurysm surgery
Secondary outcomes (3)
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.
Measured: Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively
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.
Measured: Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively
Postoperative cognitive function
The postoperative cognitive function will be measured by using of the mini-mental state examination (MMSE).
Measured: Change from baseline at 2hour,6hour,1day,3day,and 7day after aneurysm surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2015
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xu Wang, Principal investigator, Gereral Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275247
- Sponsor's protocol ID
- NXKJGG2014
- Status last verified
- May 2016
- First submitted
- 20 Oct 2014
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Effect of Stellate Ganglion Block on Cerebral Vasospasm in Patients Undergoing Aneurysm Surgery
- ClinicalTrials.gov ID
- NCT02275247
- Acronym / sponsor ID
- NXKJGG2014
- Conditions
- Intracranial Aneurysm
- Keywords
- Stellate ganglion block, Aneurysm surgery, Cognitive recovery, Cerebral vasospasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2016 (estimated)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention 'Stellate Ganglion Block' | Experimental | Drug: Stellate Ganglion BlockExperimental 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. |
| without 'Stellate Ganglion Block' | No intervention | –In the control group, every thing will be conducted as a matter of routine without intervention. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- aneurysm subarachnoid hemorrhage patients scheduled for cranial aneurysm surgery，
- ASA grade：Ⅱ-Ⅲ，
- Hunt～Hess grade :Ⅰ-Ⅲ,
- have a informed consent.
Key exclusion criteria (6 listed)
- 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，
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stellate Ganglion BlockAlso: Local anesthesia with low concentration ropivacainestellate ganglion block will be administered using either 6-8mL saline (Group 1) or 0.25% ropivacaine 6-8mL (Group 2) | Drug | Intervention 'Stellate Ganglion Block' |
Primary outcome
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.
3 secondary outcomes
Perioperative cerebral oxygen metabolism
Time frame: Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively
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
Postoperative cognitive function
Time frame: Change from baseline at 2hour,6hour,1day,3day,and 7day after aneurysm surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xu Wang principal investigator
Gereral Hospital of Ningxia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stellate Ganglion Block in people with Intracranial Aneurysm, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of cerebral vasospasm (time frame: Change from baseline at 2hour,6hour,1day,3day,and 7day after aneurysm surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2016.