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临床试验/CTRI/2024/11/077510
CTRI/2024/11/077510尚未招募不适用

Effect of Sevoflurane on vasospastic cerebral vasculature following aneurysmal sah, in patients receiving intra- arterial nimodipine, assessed by digital subtraction angiography :a prospective randomized controlled trial(SIAN-VCV trial)

Director PGIMER1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年12月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
Effect on diameter of major cerebral vessels ICA,MCA,ACA

研究概览

简要总结

subarachnoid hemorrhage following rupture of cerebral aneurysm is a life-threatening condition. Who survive many of them suffer from severe neurological and neurocognitive deficits. One of the most dangerous consequences of aneurysmal subarachnoid hemorrhage is cerebral vasospasm described as reversible constriction of cerebral blood vessels, mostly affecting major vessels of circle of  Willis . The effectiveness of oral and intra-arterial nimodipine in preventing and treating cerebral vasospasm and decreasing cerebral infraction is well established. Sevoflurane is a cerebral vasodilator. Digital subtraction angiography is a method by which direct vessel can be measured using electronic caliper. Previous study showed that effects of propofol and sevoflurane on cerebral vasculature in patients with aneurysmal subarachnoid hemorrhage using digital subtraction angiography and observed that sevoflurane has vasodilating properties compared to propofol in patients with aneurysmal subarachnoid hemorrhage

Hypothesis is that sevoflurane has synergistic effect of vasodilation with that of intra-arterial nimodipine in patients with cerebral vasospasm following aneurysmal subarachnoid hemorrhage. The mean change in vascular diameter  from baseline during  nimodipine therapy will be greater under sevoflurane anesthesia than under propofol based anesthesia in patients presenting for intra-arterial nimodipine therapy for vasospasm following aneurysmal subarachnoid hemorrhage.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Adults patients (age 18 yrs) with cerebral vasospasm following aneurysmal subarachnoid hemorrhage posted for intra-arterial nimodipine who are either unconscious,semiconscious,irritable or intubated and need for general anaesthesia for the procedure.

排除标准

  • Patient or legal heir’s refusal for consent
  • Patient with H/O allergy to test drugs
  • Patient who received intraarterial Nimodipine previously.
  • Patients having deranged renal parameters
  • Patients with vasculitis.
  • Patient having hydrocephalus.
  • Patients having abnormal coagulation parameters.

结局指标

主要结局

Effect on diameter of major cerebral vessels ICA,MCA,ACA

时间窗: Baseline before giving general anesthesia and after nimodipine administration

次要结局

  • 1. To assess changes in Cerebral Arterio-Venous Transit Time which is a surrogate marker of the cerebral blood flow by DSA.(2. Cerebral blood flow velocity (SFV/DFV/MFV), Pulsatility Index (PI) and Lindegaard ratio measured by TCD, before the procedure, 1 hour and 24 hours after procedure. These parameters will be measured once daily again for 1-5 days after IA Nimodipine.)

研究者

发起方
Director PGIMER
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sk Ahadul Islam

Post Graduate Institute of medical education and research

研究点 (1)

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