NCT06216444尚未招募4 期
A Multi-center, Randomized, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Remimazolam Tosilate (Ruibeining®) for Injection for Sedation in Non-intubated Diagnostic and Therapeutic Procedures
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Rate of sedation success, Sedation success
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 non-intubated diagnostic and therapeutic procedures
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Age ≥18 years old, male or female
- •Intending to undergo routine gastroscopy or colonoscopy
- •ASA (American Society of Anesthesiologists) I to III
- •18 kg/m2≤BMI (Body Mass Index)≤30kg/m2
- •Signed informed consent
排除标准
- •Subjects need to be tracheal intubation
- •Subjects need to be complicated endoscopic diagnostic and therapeutic procedures
- •Subjects who have had severe cardiovascular diseases or severe arrhythmias within 6 months prior to signing the ICF
- •Heart rate <50 beats/min during the screening period
- •Poor blood pressure control during the screening period
- •Subjects with severe respiratory diseases
- •Subjects with respiratory management difficulties (Modified Mallampati grade IV)
- •Subjects with a history of mental illness (schizophrenia, mania, bipolar disorder, psychosis, etc.), long-term use of psychotropic drugs, and cognitive impairment
- •A history of drug abuse or addiction within 2 years prior to signing the ICF
- •Pregnant women or those in lactation period
- •Allergic to relevant drugs ingredient or component in the study
- •Currently participating in or planning to participate in other drug or device clinical trials during this study
- •Other conditions deemed unsuitable to be included
研究组 & 干预措施
Remimazolam Tosilate for Injection（5mg）
Experimental
干预措施: Remimazolam Tosilate for Injection (Drug)
Remimazolam Tosilate for Injection（10mg）
Experimental
干预措施: Remimazolam Tosilate for Injection (Drug)
结局指标
主要结局
Rate of sedation success, Sedation success
时间窗: day 1
Rate of sedation success, Sedation success is defined as: 1) Completion of the entire non-intubated diagnostic and therapeutic procedure; 2) No need for additional rescue sedation; 3) During the sedation induction phase, the MOAA/S score should be ≤3 within 2 minutes after the end of the initial dose administration or after ≤2 additional administrations; 4) No more than 2 additional administrations in every 5-minute.
次要结局
- Percentage of subjects needing additional administration.(day 1)
- Participant's satisfaction with Sedation Assessment: The scoring range is from 0 to 10, where 0 represents dissatisfaction and 10 represents complete satisfaction.(day 1)
- Number of additional administrations.(day 1)
- Sedation induction time(day 1)
- Rate of respiratory depression during sedation.(day 1)
- Investigator's Satisfaction with Sedation Assessment: The scoring range is from 0 to 10, where 0 represents dissatisfaction and 10 represents complete satisfaction.(day 1)
- Wake-up time.(day 1)
- Time to discharge.(day 1)
- One-time success rate of endoscope insertion during the diagnostic and therapeutic procedure.(day 1)
- Rate of over-sedation.(day 1)
- Rate of sedation-related hypotension and rate of sedation-related hypotension needing treatment.(day 1)
研究者
研究点 (1)
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