A prospective randomized blinded controlled trial on the efficacy of Propofol-Fentanyl versus Ketamine-Dexmedetomidine sedation in patients with severe traumatic brain injury admitted in trauma intensive care
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Time spent in goal RASS, i.e., RASS score of -3 to -4
研究概览
简要总结
Traumatic brain injury (TBI) is a significant global health concern, causing mortality and hospitalizations. It involves both primary and secondary insults to the brain, with secondary injuries being preventable and critical to address. Sedation is crucial in managing TBI, aiming not only for symptom relief but also to optimize patient comfort and neurological outcomes. Propofol and opioids are commonly used for sedation, but they come with risks such as respiratory depression and opioid dependence. Dexmedetomidine and ketamine offer alternatives with fewer unwanted effects. This study aims to compare a traditional sedation regimen with propofol and fentanyl to an opioid-free regimen using ketamine and dexmedetomidine in severe TBI cases to reduce opioid-related risks while ensuring effective sedation and pain management.
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
- •Severe TBI with GCS less than or equal to 8 Undergoing conservative management ASA I to III.
排除标准
- •Surgical management for TBI Mild or Moderate Head Injury with GCS more than or equal to 9 Polytrauma Contraindication to use of the drugs included in the trial Lack of patient consent.
结局指标
主要结局
Time spent in goal RASS, i.e., RASS score of -3 to -4
时间窗: every 15 minutes till goal RASS is achieved and every hour thereafter till 48 hours
次要结局
- Outcome at 3 months using GOSE(At 3 months)
- Time to achieve Goal RASS(every 15 minutes till goal RASS is achieved)
- Incidence of hemodynamic alterations (hypertension, hypotension and bradycardia)(Same time as RASS.)
- Incidence of side effects of drugs used in the study like Propofol Infusion Syndrome (PRIS), constipation and acute withdrawal.(Same Time as RASS)
- Decrease in serum cortisol level at 48 hours as a measure of stress(On admission and at 48 hours)
- FOUR score at ICU discharge(At admission and Discharge)
- Incidence of Ventilator Associated Pneumonia (VAP)(Same time as RASS)
研究者
Dr Yojana Karki
Postgraduate Institute of Medical Education and Research (PGIMER)