To compare time to awakening of patients with mild traumatic head injury undergoing non-neurosurgical surgery with and without opioid-based general anaesthesia : a randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To compare the time to awakening between groups receiving opioid vs non-opioid Total Intravenous Anaesthesia
研究概览
简要总结
Traumatic Brain Injury patients often undergo emergency non-neurosurgical surgeries. Traumatic brain Injury compromises the cerebral physiology. The preferred mode of anaesthesia for TBI patients undergoing surgeries is Total Intravenous Anaesthesia using an intravenous anaesthetic agent such as propofol and an opioid such as fentanyl. The opioids( such as fentanyl) used in TIVA is known to cause sedation and prolongation of awakening of patients thereby hampering the serial assessment of GCS. Non opioid TIVA is used in a broad spectrum of surgical cases and pathologies. However there is a dearth of literature on the effects of non-opioid TIVA on TBI patients undergoing non-neurosurgical surgeries.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Polytrauma patients with mild traumatic brain injury with baseline GCS of more than or equal to 13/15, M status of 6 and baseline BIS value of more than or equal to 85 posted for non-neurosurgical surgeries within 24 hours of their injury.
- •patients with positive CT findings.
- •duration of surgery less than 4 hours.
- •patients or their relatives giving informed consent.
排除标准
- •Polytrauma patients exceeding age limit b.
- •Baseline GCS less than 13 or baseline BIS value less than 85 c.
- •Any contraindication to lignocaine use.
- •preoperative hypothermia.
- •dyselectrolytemia f.
- •Patients not requiring general anaesthesia.
- •patients or their relatives not giving consent.
- •pregnant patients.
- •patients undergoing spine surgeries.
结局指标
主要结局
To compare the time to awakening between groups receiving opioid vs non-opioid Total Intravenous Anaesthesia
时间窗: From Time of skin closure to MOAS/S Score of more than 3
次要结局
- To compare FOUR score(at time of awakening)
- To compare GCS,VAS and percentage of patients having MOAA/S score of more than 3(30minutes after shifting to PACU)
- To compare Modified Aldrete Score in PACU(time of shifting of patient)
- incidence and severity of nausea and vomitting
- incidences of adverse effects (hypotension, bradycardia, arrythmia)
研究者
Shinjini Chakraborty
Post Graduate Institute of Medical Education and Research, Chandigarh