Stellate Ganglion Block and Cerebral Vasospasm

NCT04691271 | Unknown

• 1 other identifier: Z191100006619068
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Aneurysmal Subarachnoid Hemorrhage; Stellate Ganglion Block; Cerebral Vasospasm

Keywords

Cerebral vasospasm; Stellate ganglion block

Outcome Measures

Primary Outcomes (1)

• The incidence of symptomatic vasospasm during hospitalization

  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.

  an average of 2 weeks

Secondary Outcomes (12)

• The incidence of TCD vasospasm during hospitalization

  on the days 3-5 after operation

• The incidence of CTA vasospasm on the days 3-5 after operation

  on the days 3-5 after operation

• The incidence of hypoperfusion in CTP diagnosis on the days 3-5 after operation

  on the days 3-5 after operation

• The incidence of new cerebral infarction observed on the days 90 after operation and discharge .

  on the days 90 after operation and discharge

• The changes of he mean blood flow velocity (mBFV) after operation

  on the days 3-5 after operation

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Procedure: Stellate ganglion block

Blank control group

NO INTERVENTION

In this study, a blank control was used. Routine anesthesia management and surgical operation were used without any special interventions(only an camouflaging action), and then receive standard care after operation. Only relevant statistical indicators were collected prospectively.

Interventions

Stellate ganglion block PROCEDURE

After the patient entered the operating room, early SGB will be performed by a designated experienced anesthesiologist using the B-ultrasound visualization technique. The intervention site is the ipsilateral side of the planned craniotomy site. After routine disinfection, 0.5% ropivacaine 8-10 mL will be injected into the surface of the longus colli muscle on the medial side of the prevertebral fascia at the level of the C6 anterior tubercle, and then the puncture point will be covered with sterile dressings. The success criteria of e-SGB are Horner's syndrome, which is characterized by a miosis, ptosis, enophthalmos, conjunctival hyperemia and facial reddishness without sweating. For the "camouflaging" arm, the anesthesiologist only covered the corresponding part of the patient with sterile dressings to confuse the follow-up, without any puncture. All patients will be admitted to the ICU after the operation and then receive the standard of care.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related Publications (2)

• Wu Y, Lin F, Bai Y, Liang F, Wang X, Wang B, Jian M, Wang Y, Liu H, Wang A, Chen X, Han R. Early stellate ganglion block for improvement of postoperative cerebral blood flow velocity after aneurysmal subarachnoid hemorrhage: results of a pilot randomized controlled trial. J Neurosurg. 2023 Apr 28;139(5):1339-1347. doi: 10.3171/2023.3.JNS222567. Print 2023 Nov 1.

  PMID: 37119094 DERIVED

• Jing L, Wu Y, Liang F, Jian M, Bai Y, Wang Y, Liu H, Wang A, Chen X, Han R. Effect of early stellate ganglion block in cerebral vasospasm after aneurysmal subarachnoid hemorrhage (BLOCK-CVS): study protocol for a randomized controlled trial. Trials. 2022 Nov 4;23(1):922. doi: 10.1186/s13063-022-06867-9.

  PMID: 36333751 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Vasospasm, Intracranial

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ruquan Han, M.D., Ph.D

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruquan Han, M.D., Ph.D

CONTACT

8610-59976660; ruquan.han@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 31, 2020
• Study Start: July 1, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-01

Locations

CN (1)