Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine
试验速览
- 阶段
- 4 期
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Incidence of delirium
研究概览
简要总结
The aim of this prospective randomized study is to compare the safety and efficacy of two strategies for sedation of critically ill patients submitted to mechanical ventilation: continuous intravenous infusion of dexmedetomidine versus intravenous bolus of midazolam. The two groups will be compared as to the incidence of of delirium, evaluated with the Confusion Assessment Method for ICU (CAM-ICU) and the percentage of time within the target sedation using the Richmond Agitation-Sedation Scale (RAAS).Eligible patients will be 18 years or older intubated and mechanically ventilated for less than 48 hours prior to start of study drug and anticipated ventilation duration of at least 48 hours. Calculated sample size is 146 patients (73 patients in each group)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult mechanically ventilated, critically ill patients
排除标准
- •pregnancy or lactation, severe liver disease, hearth rate less than 50, hypotension despite volemic repletion and vasoactive drug
研究组 & 干预措施
DEXMEDETOMIDINE, SEDATION
干预措施: Dexmedetomidine (Drug)
Midazolam, sedation,
干预措施: Midazolam (Drug)
结局指标
主要结局
Incidence of delirium
次要结局
- PERCENTAGE OF TIME WITHIN THE TARGET SEDATION