A Phase Ⅲ, Multicentre, Randomized, Single-blinded Study to Evaluate the Safety and Efficacy of the Sedation for Remimazolam or Propofol in Patients Undergoing Diagnostic Upper GI Endoscopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- rate of successful sedation
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the sedation for Remimazolam or Propofol in patients undergoing diagnostic upper GI endoscopy.
详细描述
This is a multi-center, ,parallel-group, single blind study using Remimazolam or propofol for sedation in patients undergoing diagnostic upper GI endoscopy.Subjects are randomized to different treatment groups (including 1 for Remimazolam Tosilate and 1 for propofol). Fentanyl are permitted during a diagnostic upper GI endoscopy.Efficacy and safety 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
- 主要目的
- Other
- 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
- •subjects aged 18-60 years；
- •intending to undergo diagnostic upper GI endoscopy;
- •ASA( American Society of Anesthesiologists) I or II；
- •18 kg/m²<BMI(Body Mass Index)<30 kg/m²;
- •the operation time of gastroscopy is not more than 30 min；
- •Signed informed consent.
排除标准
- •Patients need to be Complicated gastroscopy;
- •Patients need to be Tracheal intubation;
- •Patients with respiratory management difficulties (Modified Mallampati grade IV）;
- •one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
- •A history of drug abuse and / or alcohol abuse 2 years prior to the screening period；
- •allergic to drugs used in the study;
- •pregnant women or those in lactation period
- •The subject has participated in other clinical trial within the 3 months prior to randomization.
研究组 & 干预措施
Remimazolam Tosilate
Remimazolam Tosilate at 5mg for initial dose
干预措施: Remimazolam Tosilate (Drug)
Propofol
Propofol at 1.5mg/kg for initial dose
干预措施: Propofol (Drug)
结局指标
主要结局
rate of successful sedation
时间窗: approximately 3 hours
successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy.
次要结局
- rate of hypotension(approximately 3 hours)
- Sedation induction time(approximately 3 hours)
- Sedation recovery time(approximately 3 hours)
- rate of respiratory depression(approximately 3 hours)