NCT06222294已完成3 期
A Multi-center, Randomized, Single-blind, Parallel Controlled With Active Drug, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in the Intensive Care Unit (ICU)
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
- 214
- 试验地点
- 1
- 主要终点
- Rate of sedation success, sedation success is defined as the percentage of time maintaining target sedation in the entire drug administering time ≥ 70% without rescue sedation.
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 the ICU.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients and/or their guardians are able to provide a written informed consent, understand and agree to comply with the study requirements and protocol.
- •Subjects have been treated with endotracheal intubation and mechanical ventilation, and are expected to receive sedation after randomization at least 6 hours. The target sedation level during the period is -2 ≤ RASS ≤ +
- •18 years to 80 years old, male or female.
- •18 kg/m2 ≤ BMI ≤ 30 kg/m2.
排除标准
- •Deep sedation is required, or continuous sedation is not needed during the study process.
- •Participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation.
- •History of epilepsy or status epilepticus.
- •Myasthenia gravis or a history of myasthenia gravis.
- •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.
- •Organ failure before randomization.
- •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)
Propofol Medium and Long Chain Fat Emulsion Injection
Active Comparator
干预措施: Propofol Medium and Long Chain Fat Emulsion Injection (Drug)
结局指标
主要结局
Rate of sedation success, sedation success is defined as the percentage of time maintaining target sedation in the entire drug administering time ≥ 70% without rescue sedation.
时间窗: within 24 hours after administration of research drug
次要结局
- Percentage of time maintaining target sedation in the entire drug administering time.(within 24 hours after administration of research drug)
- Percentage of subjects receiving rescue sedation(within 24 hours after administration of research drug)
- Wake-up time.(within 6 hours after stopping the research drug)
- The number of additional doses of the research drug(within 24 hours after administration of research drug])
- The total dosage of Fentanyl(within 24 hours after administration of research drug)
- Stopping the research drug to extubation time.(within 6 hours after stopping the research drug)
- Nursing scale score(follow-up period (approx. 5-10 minutes))
研究者
研究点 (1)
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