NCT05254366已完成不适用
A Domestic, Prospective, Non-interventional Study of Remazolam Methyl Benzene Sulfonic Acid for Injection in Real-world Clinical Practice
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,022
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 2000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all safety information was obtained
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Use rebenin ® for painless gastroscopic sedation and painless colonoscopic sedation
- •Patients need to sign informed consent
排除标准
- •Patients who are participating in or planning to participate in any interventional clinical trial
- •The investigator considers that there are any other reasons for the patient's ineligibility for the study
研究组 & 干预措施
Cohort 1
Painless gastroscopic sedation cohort
干预措施: Remimazolam Tosilate for Injection (Drug)
Cohort 2
Painless colonoscopy sedation cohort
干预措施: Remimazolam Tosilate for Injection (Drug)
结局指标
主要结局
Adverse events
时间窗: Within 3 days of receiving gastroscopy and colonoscopy
Use adverse event record form,Refer to version 5.0 of the NCI-CTCAE
次要结局
- Serious adverse events(Within 3 days of receiving gastroscopy and colonoscopy)
- Adverse drug reactions(Within 3 days of receiving gastroscopy and colonoscopy)
- Injection pain questionnaire(Within 3 days of receiving gastroscopy and colonoscopy)
研究者
研究点 (1)
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