- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07652749
Stellate Ganglion Block and Prognosis of Neurological Function After Subarachnoid Hemorrhage
Effect of Stellate Ganglion Block on the Prognosis of Neurological Function After Subarachnoid Hemorrhage
The incidence of cerebral vasospasm after aneurysm subarachnoid hemorrhage (aSAH) is as high as 70%; cerebral vasospasm(CVS) is closely related to delayed cerebral ischemia (DCI), which is one of the important reasons for poor outcomes in patients with aSAH.
In recent years, it has been reported that stellate ganglion block(SGB) can effectively alleviate cerebral vasospasm(CVS), reduce cerebral blood flow velocity and increase cerebral perfusion in patients with aneurysm subarachnoid hemorrhage(aSAH)。However, whether the alleviation of CVS after SGB is beneficial to the long-term neurological prognosis has not been confirmed Therefore, a prospective randomized controlled study is needed to further explore the role of SGB block in improving the outcomes of patients with aSAH.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ruquan Han, M.D., Ph.D
- Phone Number: 8610-59976660
- Email: ruquan.han@gmail.com
Study Locations
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100070
- Beijing Tiantan Hospital, Capital Medical University
-
Contact:
- Ruquan Han, M.D., Ph.D
- Phone Number: 8610-59976660
- Email: ruquan.han@gmail.com
-
Principal Investigator:
- Ruquan Han, M.D., Ph.D
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age range: 18-65 years old;
- Within 72 hours after onset of aSAH,and planning surgical treatment(aneurysm embolizing or clipping);
- Preoperative Hunt-Hess grade 2-3
- Sign informed consent.
Exclusion Criteria:
- ASA > grade IV;
- Patients with posterior circulation aneurysm;
- Patients with severe systemic hemorrhagic diseases;
- Patients with trauma and local infection in the nerve block area;
- Local anatomic structure changes (neck structure changes caused by radiotherapy, chemotherapy and surgery);
- Allergy to known local anesthetics;
- Pregnant and lactating women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
In addition to routine anesthesia management and surgical operations, an ultrasound-guided stellate ganglion block was performed once prior to the initiation of surgery, and then receive standard care after operation.
Related statistical indicators were collected prospectively.
|
Prior to the initiation of surgery, a single ultrasound-guided stellate ganglion block was performed on the ipsilateral side of the lesion.The dose and concentration of local anesthesia: 0.5% ropivacaine 5-10ml.
Criteria for successful block: the patient developed Horner's syndrome, characterized by miosis, ptosis, eyeball caved in, nasal congestion, conjunctival congestion, reddish face and no sweat on the face
Other Names:
|
|
No Intervention: Blank control group
In this study, a blank control was used.
Routine anesthesia management and surgical operation were used without any special interventions, and then receive standard care after operation.
Only relevant statistical indicators were collected prospectively.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The modified Rankin Scale (mRS) scores at 90 days
Time Frame: 90 days postoperatively
|
The modified Rankin Scale (mRS) is used to evaluate the primary outcome.
The scale of mRS is 0 to 6.
The best neurological outcome is the mRS with 0, indicating no any symptom left.
mRS of 6 is the worst, indicating death.
mRS will be evaluated by outcomes assessor who is blinded to the grouping.
|
90 days postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The incidence of delayed cerebral ischemia (DCI) during hospitalization
Time Frame: At discharge, an average of 2 weeks
|
At discharge, an average of 2 weeks
|
|
|
All cause mortality during 90 days after onset
Time Frame: 90 days postoperatively
|
90 days postoperatively
|
|
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Length of stay in the intensive care unit and hosipital
Time Frame: At discharge, an average of two weeks
|
At discharge, an average of two weeks
|
|
|
Adverse events during hospitalization
Time Frame: At discharge, an average of 2 weeks
|
Myocardial infarction, cardiac arrest, pulmonary embolism, infection, SGB related complications, etc
|
At discharge, an average of 2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ruquan Han, M.D., Ph.D, Beijing Tiantan Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Z191100006619069
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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