NCT06169995已完成4 期
A Multi-center, Open-label，Single-arm Clinical Trial to Evaluate the Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in Upper Gastrointestinal Endoscopy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Percentage(%) of paticipants who experienced successful sedation in Upper Gastrointestinal Endoscopy
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in Upper Gastrointestinal Endoscopy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients or their guardians are able to provide a written informed consent
- •participants undergo upper gastrointestinal endoscopy
- •≥18 years old, male or female
- •18 kg/m2≤bmi≤30kg/m2
排除标准
- •Subjects to be intubated (including laryngeal mask placement);
- •Complex endoscopic diagnosis and treatment operations are required;
- •Severe cardiovascular disease within 6 months prior to signing the ICF;
- •Heart rate < 50 beats/min during screening period;
- •Subjects with poor blood pressure control during screening;
- •Severe arrhythmias or heart disease; the circulatory system is unstable;
- •Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness
- •Subjects with a history of drug abuse;
- •Abnormal values of the laboratory examination;
- •Allergic to relevant drugs ingredient or component;
- •Pregnant or nursing women;
- •Subjects who has participated in clinical trials of other interventions recently;
- •Other conditions deemed unsuitable to be included.
研究组 & 干预措施
Remimazolam Tosilate for Injection
Experimental
干预措施: Remimazolam Tosilate (Drug)
结局指标
主要结局
Percentage(%) of paticipants who experienced successful sedation in Upper Gastrointestinal Endoscopy
时间窗: on Day1
次要结局
- Incidence of sedation hypotension.(on Day1)
- The number of supplemental doses of the research drug(on Day1)
- Wake-up time.(on Day1)
- Percentage of subjects receiving supplemental dose for sedation(on Day1)
- Incidence of respiratory depression(on Day1)
研究者
研究点 (2)
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