CTRI/2024/11/076102尚未招募3 期
The Effect Of Total Intravenous Anesthesia And Inhalational Anesthesia On Neuronal And Systemic Inflammation Secondary to Early Brain Injury In Patients with Aneurysmal Subarachnoid Haemorrhage: A Prospective Randomised Controlled Trial (TIESAH)
Academic division,Sree Chitra Tirunal Institute for Medical Sciences and Technology1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluate the levels of neuroinflammatory markers and systemic inflammatory markers pre and post anaesthesia exposure in patients undergoing interventions for acute aneurysmal subarachnoid haemorrhage.
研究概览
简要总结
We plan to conduct a prospective randomized controlled trial to evaluate the effects of anesthetic agents on neuronal and systemic inflammation secondary to early brain injury in patients with acute aneurysmal subarachnoid haemorrhage undergoing interventions under Propofol based total intravenous anaesthesia versus Sevoflurane based inhalational anaesthesia.
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
- •1.American Society of Anesthesiologist (ASA) physical status class I- IV (class III & IV due to SAH) 2.Both gender 3Age 18-65 years, undergoing interventions for acute aSAH in the neurosurgery operation theatre or IR lab.
- •4.Patient’s or legally responsible relative’s consent.
排除标准
- •1.ASA class III, IV (due to other systemic comorbidities), V 2.Severe or uncompensated cardiovascular, renal, hepatic or endocrine disease 3.Pregnancy, postpartum, lactating females 4.Drug allergy to Propofol or Fentanyl 5.Refusal to consent by patient or legally responsible relative.
- •6.Patients who are intubated and on mechanical ventilation 7.Emergency surgery.
结局指标
主要结局
Evaluate the levels of neuroinflammatory markers and systemic inflammatory markers pre and post anaesthesia exposure in patients undergoing interventions for acute aneurysmal subarachnoid haemorrhage.
时间窗: 21 months for recruitment | 3 months for data analysis and compilation.
次要结局
- Evaluate the correlation of neuronal and systemic inflammatory markers with neurological and cognitive outcome in patients undergoing interventions for acute aneurysmal subarachnoid haemorrhage(21 months for recruitment)
研究者
Dr Ajay Prasad Hrishi
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum
研究点 (1)
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