The Availability and Safety Study of Remimazolam Besylate for Injection on Sedation of ERAS Patients Under Mechanical Ventilation in ICU: Protocol for a Randomized, Open-label, Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 84
- 主要终点
- Satisfaction rate of sedation
研究概览
简要总结
This trial intends to evaluate Remimazolam Besylate's availability and safety compared 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
- None
盲法说明
This is a open label clinical trial.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental group: Remimazolam Besylate
Patients should be given study drugs as soon as possible after entering the ICU. Syringe pump is used to administer medication. Loading dose of Remimazolam is 0.2 mg/kg, which is administered for less than 1 min initially. Maintaining dose is 0.2-1 mg/kg/h. Sedative target is RASS between 0 and -2 points. Excepts for fentanyl and Remimazolam, no analgesic or sedative could be used during the experimental time period.
干预措施: Remimazolam Besylate (Drug)
Positive control group: Propofol
Patients should be given study drugs as soon as possible after entering the ICU. Syringe pump is used to administer medication. Loading dose of propofol is 0.2 mg/kg, which is administered for less than 1 min initially. Maintaining dose is 0.3-4.0 mg/kg/h. Sedative target is RASS between 0 and -2 points. Excepts for fentanyl and propofol, no analgesic or sedative could be used during the experimental time period.
Rescue therapy for experimental group During the treatment of the experimental group, if the RASS cannot be maintained at 0 to -2 points at the maximum Remimazolam maintenance dose of 1 mg/kg/h, a loading dose of propofol (0.2 mg/kg) can be given intravenously. If RASS fails to satisfied after three loading doses of propofol, Remimazolam is discarded and 0.3-4.0 mg/kg/h of propofol are used as rescue therapy for experimental group.
干预措施: Propofol (Drug)
结局指标
主要结局
Satisfaction rate of sedation
时间窗: 24 hours since injection of sedatives
(number of subjects that meets satisfied RASS score under prescribed dose of sedative agents during study / total number of subjects) ×100%
Rate of major clinical events
时间窗: 48 hours since injection of sedatives
(number of subjects that suffer from major clinical events during study / total number of subjects) ×100%. Major clinical events are defined as cardiac arrest, malignant arrhythmia, new onset of shock, new onset of sepsis and respirate failure unrelated to primary illness.
次要结局
- incidence of delirium(48 hours since injection of sedatives)
- Time to weaning and extubation(48 hours since injection of sedatives)
- Difficulty of nursing(48 hours since injection of sedatives)
- 28-days survival(28 days since injection of sedatives)
- incidence of rescue therapy in experimental group(24 hours since injection of sedatives)