A Study Comparing Remimazolam Tosilate and Propofol for Intravenous General Anaesthesia in Operations
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- successful anaesthesia rate as measured by the proportion of subjects who experienced succesful anesthesia during operations
研究概览
简要总结
The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as an intravenous general anaesthetic drug in operations and to determine its efficacy and safety profile comparing to propofol.
详细描述
This is an multi-center，double-blinded，parallel and control study using Remimazolam or propofol for anesthesia in operations.Subjects are randomized to different treatment groups (including 3 for Remimazolam Tosilate and 1 for propofol) and anaesthetics are pumped contimuously into bodies.Analgesics and muscle relaxants are permitted during operations.Efficacy，safety and pharmacokinetic/pharmacodynamic profiles of Remimazolam Tosilate are to be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects aged 18-60 years；
- •intending to have non-emergency operations；
- •ASA( American Society of Anesthesiologists) I or II；
- •18 kg/m²<BMI(Body Mass Index)<30 kg/m².
排除标准
- •people with contraindications to general anaesthesia;
- •one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
- •history of recent use of narcotics,analgesics,anaesthetics and benzodiazepine hypnotics;
- •history of severe cardiovascular disease;
- •uncontrolled blood glucose level;
- •cerebral disease or mental disorder;
- •allergic to drugs used in the study;
- •pregnant women or those in lactation period.
研究组 & 干预措施
Remimazolam Tosilate 1
IV pumping of Remimazolam Tosilate at 6mg/kg/h for anesthesia induction
干预措施: Remimazolam Tosilate (Drug)
Remimazolam Tosilate 2
intravenous pumping of Remimazolam Tosilate at 12mg/kg/h for anesthesia induction
干预措施: Remimazolam Tosilate (Drug)
Remimazolam Tosilate 3
intravenous pumping of Remimazolam Tosilate at 18mg/kg/h for anesthesia induction
干预措施: Remimazolam Tosilate (Drug)
Propofol
single IV bolus of Propofol at 2.0-2.5mg/kg for anesthesia induction
干预措施: Propofol (Drug)
结局指标
主要结局
successful anaesthesia rate as measured by the proportion of subjects who experienced succesful anesthesia during operations
时间窗: an average of 3 hours (immediately after opaerations)
次要结局
- bispectral index(BIS) during anaesthesia as measured by bispectral index machine(every 5 minutes)
- recovery time as measured by time(an average of 3 hours (after cessation of anesthetics pumping))
- induction time as measured by time(1-10 minutes (from the begining of anesthetics))