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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04691271
Other study ID # Z191100006619068
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date December 30, 2024

Study information

Verified date January 2024
Source Beijing Tiantan Hospital
Contact Ruquan Han, M.D., Ph.D
Phone 8610-59976660
Email ruquan.han@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 202
Est. completion date December 30, 2024
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
Stellate ganglion block
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.

Locations

Country Name City State
China Beijing Tiantan Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The incidence of TCD vasospasm during hospitalization 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. on the days 3-5 after operation
Secondary The incidence of CTA vasospasm 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. on the days 3-5 after operation
Secondary The incidence of hypoperfusion in CTP diagnosis on the days 3-5 after operation The incidence of hypoperfusion in CTP diagnosis on the days 3-5 after operation
Secondary The incidence of new cerebral infarction observed 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. on the days 90 after operation and discharge
Secondary The changes of he mean blood flow velocity (mBFV) after operation the changes in the mean blood flow velocity (mBFV) of all large intracranial anterior circulation vessels on the days 3-5 after operation
Secondary Total length of stay in the intensive care unit and hospital. Days on the 90 days
Secondary The modified Rankin scale at discharge, 30days, and 90 days The modified Rankin scale =2 is defined as good prognosis on the 30 and 90 days
Secondary All-cause mortality rate up to 90 days. The rate on the 90 days
Secondary Postoperative delirium incidence during hospitalization The rate on the days 1-3 after operation
Secondary Postoperative cognitive dysfunction The rate At discharge,an average of 2 weeks
Secondary The proportion of remedial treatment after CVS The rate At discharge,an average of 2 weeks
Secondary Adverse events during hospitalization Myocardial infarction, cardiac arrest, pulmonary embolism, infection, SGB related complications, etc At discharge,an average of 2 weeks
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