A prospective randomized study to determine the effect of perioperative stellate ganglion block on cerebral vasospasm in aneurysmal subarachnoid haemorrhage patients.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- PRIMARY OUTCOME - To compare the incidence of TCD defined cerebral vasospasm MCA or ACA velocity more than 120cm per second in patients receiving perioperative Stellate Ganglion Block versus standard treatment group which is the control group here.
研究概览
简要总结
Patients will be enrolled based on the following inclusion and exclusion criteria. Patients with aSAH diagnosed by imaging (CTA or DSA) and scheduled for surgical intervention within the time period of 72h after ictus will be assessed for recruitment.All TCD measurements would be performed by another observer who would be blinded to the intervention received in the patients. TCD will be monitored by VIASONIX Dolphin/4D model by Viasonix Ltd, Israel. TCD monitoring will be performed before surgery (T0) baseline and on the subsequent post operative days, 1st (T1), 2nd (T2), 3rd (T3), 5th (T4) and 7th (T5) after the operation or earlier if discharged from ICU before 7 days. The incidence of complications, including myocardial infarction, postoperative rebleeding, moderate and severe brain oedema, pulmonary embolism, deep venous thrombosis, SGB-related complications, unexpected adverse events and intra operative complications will also be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •18 years to 65 years, Anterior circulation aneurysms, Planned aneurysm clipping, Pre operative Hunt and Hess grade I II and III.
排除标准
- •ASA physical status more than III Posterior circulation aneurysm Multiple aneurysms Allergy to known local anaesthetics Pregnant women.
结局指标
主要结局
PRIMARY OUTCOME - To compare the incidence of TCD defined cerebral vasospasm MCA or ACA velocity more than 120cm per second in patients receiving perioperative Stellate Ganglion Block versus standard treatment group which is the control group here.
时间窗: TCD will be used to measure cerebral blood flow velocity in MCA or ACA preoperatively day 0 and after surgery on day 1,2,3,5 and 7th day.
次要结局
- Incidence of symptomatic cerebral vasospasm within 14 days after aSAH(Any additional intervention done for cerebral vasospasm)
研究者
Dr Rajat Chauhan
All India Institute of medical Sciences, New Delhi