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临床试验/CTRI/2023/07/054635
CTRI/2023/07/054635进行中(未招募)3 期

Effect of intravenous anaesthetics versus inhalational anaesthetics on delayed cerebral ischemia following aneurysmal sah: a randomised clinical trial (IVIA-DAS)

Postgraduate Institute of Medical Education and Research1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年7月13日最近更新:

试验速览

阶段
3 期
状态
进行中(未招募)
入组人数
200
试验地点
1
主要终点
To compare the incidence of delayed cerebral ischemia in patients undergoing

研究概览

简要总结

This trial is designed to see the effect of anaesthesia drugs on the incidence of delayed cerebral ischemia in patients of aneurysmal subarachnoid haemorrhage undergoing surgical clipping of the neck of aneurysm.  after randomly dividing into two groups, patients of one group will receive propofol( intravenous)  as an anaesthetic agent, while the other will receive sevoflurane ( inhalational) as the anaesthetic agent. Postoperatively these patients are followed up to compare the incidence of Delayed cerebral ischemia between the two groups. Secondarily we reach CSF levels of the eNOS enzyme, collected at the time of surgery. we also check neurological outcomes using MRS scoring at discharge and both MRS and GOSE scale at 1 month and w3 months.w

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant 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

  • Ruptured aneurysm posted for Surgical Clipping WFNS grade 1,2,3 Anterior circulation aneurysm.

排除标准

  • Postictal day 4 or more Postoperative neurological deterioration due to surgical or systemic causes Hydrocephalus.

结局指标

主要结局

To compare the incidence of delayed cerebral ischemia in patients undergoing

时间窗: starting after the surgery till the discharge from hospital

to propofol.

时间窗: starting after the surgery till the discharge from hospital

clipping of aneurysm surgery under general anesthesia with sevoflurane when compared

时间窗: starting after the surgery till the discharge from hospital

次要结局

  • Estimation of CSF eNOS levels(intraoperative ( during aneurysm Clipping surgery))
  • Neurological outcome at discharge ( MRS score)(at discharge)
  • Neurological outcome at 3 months post surgery(GOSE, MRS score)(1 months after surgery, 3 months after surgery)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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