NCT03921775已完成3 期
A Multicenter, Randomized, Single-blind, Parallel and Control Phase III Trial Evaluating the Efficacy and Safety of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective Surgery.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Percentage(%) of paticipants who experienced successful anesthesia during operation in each group
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of remimazolam tosilate compared to propofol for general anesthesia during elective surgery.
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
- Single (Participant)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment group A
Experimental
IV pumping of remimazolam tosilate at 6mg/kg/h for anesthesia induction and 1mg/kg/h for anesthesia maintenance
干预措施: Remimazolam Tosilate (Drug)
Treatment B
Active Comparator
IV pumping of propofol at 120~150mg/kg/h for anesthesia induction and 3~12mg/kg/h for anesthesia maintenance
干预措施: Propofol (Drug)
结局指标
主要结局
Percentage(%) of paticipants who experienced successful anesthesia during operation in each group
时间窗: Average of 2 hours
次要结局
- Time from stop of investigational medicinal product to MOAA/S Score=5(Average of 2 hours)
- Time from start of investigational medicinal product administration to loss of consciousness(Average of 2 hours)
- Time from stop of investigational medicinal product to Aldrete Score>9(Average of 2 hours)
研究者
研究点 (1)
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