Comparison of ketofol vs sevoflurane on brain relaxation in patients with severe traumatic brain injury a prospective randomised controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Comparison of ketofol vs sevoflurane on brain relaxation score (BRS) at the time of opening of dura during emergency decompressive neurosurgery in severe traumatic brain injury patient
研究概览
简要总结
Our study proposes a prospective, RCT to compare the effect of ketofol versus sevoflurane based anaesthesia on brainn relaxation during emergency decompressive surgery in severe traumatic brain injury patients. The study will also assess intra-operative hemodynamics to determine which anaesthetic agent is better for severe TBI patients. Additionally, the trial will evaluate the neurological outcome of the patients at discharge and at 30 and 90-days post-injury, aiming to identify any difference in functional recovery. This research will provide valuable insights into the optimal anaesthetic choice for improving both immediate surgical outcomes and long term recovery in severe TBI patients.
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
- 16.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with severe head injury GCS less than 9, scheduled for emergency evacuation of acute traumatic hematoma such as subdural hematoma, brain contusion, subarachnoid haemorrhage, diffuse axonal injury or a combination of these injuries.
排除标准
- •Patients with extradural hematoma (EDH), TBI patients managed conservatively, associated cervical spine injury, major thoraco-abdominal trauma or patients with history of uncontrolled hypertension, cardiac, renal, hepatic dysfunction, psychiatric disorder, neurodegenerative disorder, pregnancy, history of allergic reaction to study drug and those refusing consent will be excluded from the study.
结局指标
主要结局
Comparison of ketofol vs sevoflurane on brain relaxation score (BRS) at the time of opening of dura during emergency decompressive neurosurgery in severe traumatic brain injury patient
时间窗: Brain relaxation between ketofol and sevoflurane maintenance group of anaesthesia in patents with severe traumatic brain injury undergoing emergency decompressive neurosurgery will be noted at the time of opening the dura using a 4 point brain relaxation score.
次要结局
- To compare the effect of ketofol vs sevoflurane on(1. Intra-operative hemodynamics)
研究者
Sankho Chouudhury
All India Institute Of Medical Sciences, New Delhi