A Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy.
研究概览
简要总结
The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as a procedural sedative during a diagnostic upper GI endoscopy and to assess its efficacy and safety profile comparing to propofol.
详细描述
This is an multi-center,single-blinded,parallel-group,dose-finding study using Remimazolam or propofol for sedation in patients undergoing diagnostic upper GI endoscopy.Subjects are randomized to different treatment groups (including 4 for Remimazolam Tosilate and 1 for propofol).Lidocaine and 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
- •American Society of Anesthesiologists Physical Status Score (ASA PS) I or II；
- •18 kg/m²<BMI(Body Mass Index)<30 kg/m².
排除标准
- •Patients with a suspected upper GI bleed an conditions predisposing to hemorrhage at the discretion of the investigator;
- •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;
- •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 of Remimazolam Tosilate at 5mg for initial dose
干预措施: Remimazolam Tosilate (Drug)
Remimazolam Tosilate 2
IV of Remimazolam Tosilate at 7mg for initial dose
干预措施: Remimazolam Tosilate (Drug)
Remimazolam Tosilate 3
IV of Remimazolam Tosilate at 8mg for initial dose
干预措施: Remimazolam Tosilate (Drug)
Remimazolam Tosilate 4
IV of Remimazolam Tosilate at 5mg for initial dose.At the end of the endoscopy, flumazenil was injected.
干预措施: Remimazolam Tosilate (Drug)
Propofol
IV of Propofol at 1.5mg/kg for initial dose
干预措施: Propofol (Drug)
结局指标
主要结局
successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy.
时间窗: From start of study drug injection to patient discharge (approx. 3 hours)
次要结局
- rate of hypotension as measured by the proportion of subjects who experienced hypotension during a diagnostic upper GI endoscopy(From start of study drug injection to patient discharge (approx. 3 hours))
- rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression during a diagnostic upper GI endoscopy(From start of study drug injection to patient discharge (approx. 3 hours))
- rate of hypoxaemia as measured by the proportion of subjects who experienced hypoxaemia during a diagnostic upper GI endoscopy(From start of study drug injection to patient discharge (approx. 3 hours))
- pain on injection was assessed by the patient immediately after administration of the study drug(1-10 minutes (from the beginning of sedation )])
- recovery time as measured by time(After the last of study drug injection to patient discharge (approx. 3 hours))