Stellate Ganglion Block and Cerebral Vasospasm

Not Applicable

Recruiting

• Conditions: Cerebral Vasospasm; Stellate Ganglion Block; Aneurysmal Subarachnoid Hemorrhage
• Interventions: Procedure: Stellate ganglion block

• Registration Number: NCT04691271
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

At present, cerebral vasospasm (cVS) is the main cause of delayed cerebral infarction (DCI), which leads to high disability and mortality rate after aneurysmal subarachnoid hemorrhage. As a consequence, the key of reducing DCI is to prevent cVS. But unfortunately, despite years of efforts, the prevention and treatment of cVS is still a major clinical dilemma and various ways of treatment are still being explored. Recent studies have shown that stellate ganglion block (SGB) can dilate cerebral vessels and alleviate the impact of existing cVS. However, there is no study to evaluate the effect of early application of SGB on the improvement and prevention of cVS after aSAH.

Detailed Description

Cerebral vasospasm refers to the extensive segmental or diffuse contraction of cerebral vasculature after aSAH, and cerebral blood flow is significantly reduced, which can lead to delayed cerebral ischemia (DCI) or delayed ischemic neurological dysfunction (DIND). Past studies have shown that if cerebral vasospasm occurs in patients with aSAH, the proportion of ischemic brain injury can be as high as 20%-30%.Obviously, prevention and treatment of CVS are the key to reducing the disability and mortality of aSAH.

Study Timeline

• Study First Submitted: 2020-12-13
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-31
• Study Start: 2021-07-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

• Age range: 18-65 years old;
• Within 48 hours after onset of aSAH,and planning surgical treatment(aneurysm clipping);
• Preoperative Hunt-Hess grade 2-3
• Sign informed consent.

Exclusion Criteria

• ASA > grade III;
• Patients with posterior circulation aneurysm, ophthalmic aneurysms or internal carotid aneurysms;
• patients with multiple aneurysms;
• Patients with severe coagulation dysfunction;
• Patients with trauma and local infection in the nerve block area;
• Local anatomic structure changes (neck structure changes caused by radiotherapy, chemotherapy and surgery);
• MCA stenosis or infarction was found by preoperative imaging;
• Patients with poor temporal window signal revealed by preoperative TCD (clear waveform image could not be obtained);
• Allergy to known local anesthetics;
• Pregnant and lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Stellate ganglion block	In addition to routine anesthesia management and surgical operations, a stellate ganglion block was performed before induction of anesthesia, and then receive standard care after operation. Related statistical indicators were collected prospectively.

Primary Outcome Measures

Name	Time	Method
The incidence of symptomatic vasospasm during hospitalization	an average of 2 weeks	Symptomatic vasospasm is defined as new focal or global neurological dysfunction or a decrease in the Glasgow coma score by more than 2 points, and with angiographic vasospasm on TCD or CTA.

Secondary Outcome Measures

Name	Time	Method
The incidence of hypoperfusion in CTP diagnosis on the days 3-5 after operation	on the days 3-5 after operation	The incidence of hypoperfusion in CTP diagnosis
The proportion of remedial treatment after CVS	At discharge，an average of 2 weeks	The rate
All-cause mortality rate up to 90 days.	on the 90 days	The rate
Postoperative delirium incidence during hospitalization	on the days 1-3 after operation	The rate
Total length of stay in the intensive care unit and hospital.	on the 90 days	Days
The incidence of TCD vasospasm during hospitalization	on the days 3-5 after operation	The mean blood flow velocity (MFV) of the middle cerebral artery ≥ 120 cm/s or Lindegaard index (ratio of MFV of the middle cerebral artery to the internal carotid artery) ≥ 3.
The incidence of new cerebral infarction observed on the days 90 after operation and discharge .	on the days 90 after operation and discharge	New cerebral infarction is defined only as the appearance of new low-density infarct shadow on CT image compared with preoperation.
The changes of he mean blood flow velocity (mBFV) after operation	on the days 3-5 after operation	the changes in the mean blood flow velocity (mBFV) of all large intracranial anterior circulation vessels
The modified Rankin scale at discharge, 30days, and 90 days	on the 30 and 90 days	The modified Rankin scale ≤2 is defined as good prognosis
Adverse events during hospitalization	At discharge，an average of 2 weeks	Myocardial infarction, cardiac arrest, pulmonary embolism, infection, SGB related complications, etc
The incidence of CTA vasospasm on the days 3-5 after operation	on the days 3-5 after operation	Compared with the preoperative baseline, the corresponding vessel diameter narrowed by more than 30% or new segmental stenosis occurred, not related to atherosclerosis or mechanical artery stenosis caused by arterial clamps or coils.
Postoperative cognitive dysfunction	At discharge，an average of 2 weeks	The rate

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China