Pharmacokinetic Study of Continuous Infusion of Remazolam in Mechanically Ventilated Patients in ICU : Establishment of Population Pharmacokinetic Model and Exploration of Clinical Influencing Factors
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Plasma concentration of Remimazolam
研究概览
简要总结
To study the pharmacokinetics of continuous infusion of remazolam in ICU mechanically ventilated critically ill patients, and the characteristics of PK in patients with liver failure; to explore whether liver failure affects the metabolism of remazolam by established population pharmacokinetics.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to ICU for tracheal intubation and mechanical; Patients aged >18 years; Patients with expected mechanical ventialation time >24 hours.
排除标准
- •Patients on long-term anti-anxiety medication or sleeping pills; Patients with known or suspected hypersensitivity to remimazolam; Patients with severe central nervous system diseases; Patients who do not wish to sign the informed consent form.
研究组 & 干预措施
Remimazolam 0.3mg/kg/h
Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.3 mg/kg/h.
干预措施: Remimazolam 0.3mg/kg/h (Drug)
Remimazolam 0.1mg/kg/h
Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.1 mg/kg/h.
干预措施: Remimazolam 0.1mg/kg/h (Drug)
Remimazolam 0.5mg/kg/h
Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.5 mg/kg/h.
干预措施: Remimazolam 0.5mg/kg/h (Drug)
结局指标
主要结局
Plasma concentration of Remimazolam
时间窗: 24 hours
Plasma concentration of Remimazolam
次要结局
- Adverse reactions(28 days)