NCT05836545已完成3 期
A Randomized, Single-Blind, Investigator Initiative Trial Study of Remimazolam Versus Midazolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy
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
- 132
- 试验地点
- 1
- 主要终点
- Total procedure time
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of remimazolam with midazolam in patients undergoing gastrointestinal endoscopy. The main questions it aims to answer are:
- Superiority of total procedure time in remimazolam compared to midazolam
- The success of sedation time
This is the single blind study.; Patients will not know what they are given as the sedation drug If there is a comparison group: Researchers will compare patients with midazolam group to see if remimazolam group is superior to midazolam group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Patients who agreed for this clinical trials
- •Patients who want diagnostic endoscopy under sedation
- •The total procedure time which is predicted within 15 minutes
- •BMI more than 18.5kg/m2, less than 30kg/m2
排除标准
- •Patients who have stomach illness
- •Patients with respiratory disease
- •Mallampati Score>=3
- •Systolic BP >160mmHg or <90mmHg
- •Refractory Hypertension
- •Uncontrolled glaucoma
- •Severe liver failure or chronic kidney disease
- •Patients with drug abuse or alcohol abuse within 1 year
- •Patients who are sensitive for certain medication (such as benzodiazepine, remimazolam)
- •Obstructive sleep dyspnea patients
- •Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •Pregnant, breast feeding patient
研究组 & 干预措施
Midazolam
Active Comparator
The patient with midazolam
干预措施: Midazolam (Drug)
Remimazolam
Experimental
The patient with remimazolam
干预措施: Remimazolam (Drug)
结局指标
主要结局
Total procedure time
时间窗: begin when the drug is give to when the endoscopy is withdrawn
次要结局
- The success rate of sedation(Completion of the whole endoscopy procedures, No requirement for an alternative and/or rescue sedative, Administered up to a maximum of five supplemental doses within 15 mnutes after the initial dose)
研究者
研究点 (1)
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