NCT04400201已完成3 期
A Phase III Clinical Study Evaluating the Efficacy and Safety of Remimazolam Tosilate Compared to Propofol in Patients Undergoing Bronchoscopy
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 participants who experienced successful sedation in undergoing bronchoscopy in each group
研究概览
简要总结
A multicenter, randomized, single-blind, active controlled, parallel group study comparing remimazolam tosilate to propofol in patients undergoing bronchoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18~80 years, female or male
- •Patients scheduled for an bronchoscopy procedure
- •18 kg/m2<BMI<30kg/m2
- •Patients understand clearly and participate in the study voluntarily, and sign the informed consent
排除标准
- •Patients scheduled for emergency surgery
- •Patients with a history of drug abuse and / or alcohol abuse 2 years prior to the screening period
- •One or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
- •Pregnant women or those in lactation period
- •Allergic to drugs used in the study
- •Patients have participated in other clinical trial within the 3 months prior to randomization
- •Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the subject for any other reason
研究组 & 干预措施
Remimazolam Tosilate
Experimental
干预措施: Remimazolam Tosilate (Drug)
Propofol
Active Comparator
干预措施: Propofol (Drug)
结局指标
主要结局
Percentage (%) of participants who experienced successful sedation in undergoing bronchoscopy in each group
时间窗: From the onset of administration of the study drug to removal of bronchoscope on Day 1 of treatment
次要结局
- Time from start of investigational medicinal product administration to loss of consciousness(From the onset of administration of the study drug to unconsciousness on Day 1 of treatment)
- Time from stop of investigational medicinal product to MOAA/S Score=5(From the last dose of study drug until the patient has recovered to fully alert on Day 1 of treatment)
- Time from stop of investigational medicinal product to Aldrete Score≥9(From the end of administration of the study drug until the patient reaches the modified Aldrete's system score of ≥9 points on Day 1 of treatment)
研究者
研究点 (1)
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