Effect of Early Stellate Ganglion Block for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage: a Randomized Controlled Trial (BLOCK-CVS)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- The incidence of symptomatic vasospasm during hospitalization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention group
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.
干预措施: Stellate ganglion block (Procedure)
Blank control group
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.
结局指标
主要结局
The incidence of symptomatic vasospasm during hospitalization
时间窗: 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.
次要结局
- The incidence of hypoperfusion in CTP diagnosis on the days 3-5 after operation(on the days 3-5 after operation)
- All-cause mortality rate up to 90 days.(on the 90 days)
- Postoperative delirium incidence during hospitalization(on the days 1-3 after operation)
- Total length of stay in the intensive care unit and hospital.(on the 90 days)
- The proportion of remedial treatment after CVS(At discharge，an average of 2 weeks)
- The incidence of TCD vasospasm during hospitalization(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)
- The modified Rankin scale at discharge, 30days, and 90 days(on the 30 and 90 days)
- Adverse events during hospitalization(At discharge，an average of 2 weeks)
- The incidence of CTA vasospasm on the days 3-5 after operation(on the days 3-5 after operation)
- Postoperative cognitive dysfunction(At discharge，an average of 2 weeks)
研究者
Ruquan Han
Professor
Beijing Tiantan Hospital