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临床试验/CTRI/2024/09/073599
CTRI/2024/09/073599尚未招募不适用

Effect of Remote Ischemic Post-Conditioning Vs Sham on Jugular Venous Oximetry and three-month neurological outcomes in patients Undergoing Intracranial Aneurysmal Clipping: A Randomized controlled trial.

All India Institute of Medical Sciences, Bhubaneswar1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年9月20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
50
试验地点
1
主要终点
To assess the effect of RIPC on Cerebral Oxygenation as measured on jugular venous catheter (SjvO2) at 24hours after aneurysm clipping

研究概览

简要总结

This randomized controlled trial is aimed to study the effects of remote ischemic post-conditioning (RIC) versus a sham procedure on jugular venous oximetry and three-month neurological outcomes in patients undergoing intracranial aneurysmal clipping. Aneurysmal subarachnoid hemorrhage (aSAH), caused by ruptured intracranial aneurysms, is a significant global health issue with high morbidity and mortality rates. Cerebral vasospasm and delayed cerebral ischemia (DCI) are common complications of aSAH, contributing to poor outcomes.

Remote ischemic conditioning (RIC), which involves inducing brief periods of ischemia, has shown promise in reducing ischemia-reperfusion injury in various organs, including the brain. Previous studies have explored RIC in different contexts, such as pre-procedural RIC, early postconditioning, and chronic postconditioning, with some showing beneficial effects in cerebrovascular diseases and post-aneurysm repair surgery.

While RIC has been investigated for its potential to mitigate cerebral vasospasm and improve outcomes after aSAH, there is a lack of research on its impact on jugular venous oximetry during aneurysmal clipping procedures. This study aims to address this gap by evaluating whether RIC can improve cerebral oxygenation and neurological outcomes in this patient population, hypothesizing that RIC may protect against cerebral vasospasm and ischemic injury, leading to better cerebral oxygenation and improved neurological recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • Consent by the patient or closest of kin ASA grade I-IV individuals Aged 18-65years, scheduled for surgical clipping of the ruptured aneurysm during the study period Patients presenting up to 7 days of ictus.
  • Modified Hunt and Hess Grade 1 to 3.

排除标准

  • Patients not willing to give consent Hunt and Hess Grade more than 3 Patients requiring inotropic support preoperatively DVT and history of peripheral vascular disease.

结局指标

主要结局

To assess the effect of RIPC on Cerebral Oxygenation as measured on jugular venous catheter (SjvO2) at 24hours after aneurysm clipping

时间窗: 24hours after aneurysm clipping

次要结局

  • Incidence of cerebral deoxygenation in the two group within 7 days after surgery.(7 days)
  • Days spent in Vasospasm diagnosed by TCD between groups(7 days post op or until discharge from ICU)
  • Quantitative Troponin I level at 48hrs in between groups.(48hrs after aneurysm clipping)
  • CT-Angiography and Perfusion CT on POD 7 to assess mean transit time (MTT), cerebral blood flow (CBF) and cerebral blood volume (CBV).(post op day 7)
  • GOSE and Modified Rankin Scales(at discharge and 3months)

研究者

发起方
All India Institute of Medical Sciences, Bhubaneswar
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Nitasha Mishra

All India Institute of Medical Sciences, Bhubaneswar

研究点 (1)

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