Dexmedetomidine Versus Propofol for Prolonged Sedation in Poly Traumatized Mechanically Ventilated Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- percentage of time with in the target sedation range of Richmond Agitation Sedation Scale-3-0
研究概览
简要总结
Dexmedetomidine, a central and peripheral α2-receptor agonist distinct from GABA receptor for benzodiazepines and propofol, has been approved by the US Food and Drug Administration only for use up to 24 h in mechanically ventilated patients. The investigators aim to compare dexmedetomidine with propofol for sedation >24h in poly traumatized mechanically ventilated patients.
详细描述
The importance of optimizing the levels of sedation in critical care has been increasingly recognized. Many intensive care experts are focusing on maintaining a targeted ''ideal'' sedation level according to the individual patient's condition to avoid adverse events such as prolonged mechanical ventilation, respiratory depression, pneumonia, delirium, psychological problems, and increased treatment costs resulting from over sedation. Dexmedetomidine is a selective alpha-2-adrenoceptor agonist. It exerts both sedative and analgesic effects via mechanisms different from other sedatives such as midazolam and propofol, and provides sedation characterized by prompt response to stimuli with no respiratory depression. The investigators aim to compare dexmedetomidine with propofol for sedation >24h in poly traumatized mechanically ventilated patients. The investigators will perform a prospective, single center trial to investigate the safety and efficacy of dexmedetomidine for long-term sedation in poly traumatized mechanically ventilated ICU patients, in comparison with propofol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Endotracheal Intubation
- •Mechanical ventilation
- •Poly traumatized
- •ICU patients and estimated duration of sedation>24 h.
排除标准
- •Patients with serious trauma in the central nervous system,
- •with bleeding probably requiring surgical hemostasis,
- •drug overdose within the last 30 days before study entry,
- •pregnancy/lactation,
- •contraindication to alpha-2-adrenoceptor agonists or antagonists,
- •cardiovascular disease,
- •conduction disturbances or difficulty in data collection or completing the study protocol
研究组 & 干预措施
Dexmedetomidine
Dexmedetomidine intravenous sedation at 0.2-0.7 µg/kg/h for >24h.
干预措施: Dexmedetomidine (Drug)
Propofol
Propofol sedation at 10-70µg/kg/h for >24h.
干预措施: Propofol (Drug)
结局指标
主要结局
percentage of time with in the target sedation range of Richmond Agitation Sedation Scale-3-0
时间窗: 3 days
sedation goal is to maintain Richmond Agitation Sedation Scale from -3 up to 0
次要结局
- Serum creatinine.(3-days)
- Systolic blood pressure(3- days.)
- serum BUN(3-days)
- heart rate(3- days.)
- diastolic blood pressure(3- days.)
研究者
Hala Saad Abdel-Ghaffar
MD
Assiut University