The Psychological Effects of Different Sedation Protocol on Mechanically Ventilated Critically Ill adults-a Prospective, Randomized and Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 主要终点
- The incident rate of delirium
研究概览
简要总结
The study was designed to explore the effects of different sedation protocol on incidence rates of delirium and PTSD in severe patients with mechanically ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Critically ill adults whose expected time of mechanical ventilation is longer than 24 hours
- •Aged between 18 years old to 85 years old.
排除标准
- •Subjects with brain injury;
- •History of cardiopulmonary resuscitation;
- •Mental disability;
- •Taken neuromuscular blocking drugs;
- •Inability to exchange;
- •Contraindicated to midazolam or morphine;
- •Inconvenience to daily interruption
研究组 & 干预措施
Deep sedation
Injection of 0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,then continuous intravenous infusion 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl to maintain sedation until attaining the target level of sedation,RASS score between -5 and -3
干预措施: Deep sedation(midazolam and fentanyl ) (Drug)
Deep and daily interruption of sedation
Injection of 0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,then continuous intravenous infusion 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl to maintain sedation until attaining the target level of sedation,RASS score between -5 and -3.and from the second day after subject was admitted in ICU, daily interruption of sedation will be taken .
干预措施: Deep and daily interruption of sedation(midazolam and fentanyl ) (Drug)
Light sedation
Injection of 0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,then continuous intravenous infusion 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl to maintain sedation until attaining the target level of sedation,RASS score between -2 and +1.
干预措施: Light sedation(midazolam and fentanyl ) (Drug)
结局指标
主要结局
The incident rate of delirium
时间窗: From weaning to discharged from ICU,about 7 days.
The incident rates of PTSD
时间窗: 30th day and 180th day after discharged from ICU
The duration of delirium
时间窗: From weaning to discharged from ICU,about 7 days.
次要结局
- Incidence rate of unexpected extubation(From intubation to weaning,about 7 days)
- Dosage of analgesics and sedatives(From intination of analgesics and sedatives to stopping drug appication,about 7 days)
- The duration of mechanical ventilation(From intubation to weaning,about 7days)
- Duration of ICU(From admitted to ICU to discharged from ICU,about 7 days)
- The whole hospitalization time(From admitted to hospital to discharged from hospital,about 7 days)
- Patients' death rates within ICU stay(From admitted to ICU to discharged from ICU,about 7 days)
- Patients' death rates within hospitalized stay(From admitted to hospital to discharged from hospital,about 7 days)
- The cost in ICU(From admitted to ICU to discharged from ICU,about 7 days)
- The total cost in hospital(From admitted to hospital to discharged from hospital,about 7 days)