Aneurysmal Subarachnoid Hemorrhage Clinical Trial
— BLOCK-CVSOfficial title:
Effect of Early Stellate Ganglion Block for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage: a Randomized Controlled Trial (BLOCK-CVS)
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tiantan Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tiantan Hospital |
China,
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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