NCT05152303已完成2 期
Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in the Intensive Care Unit (ICU) - a Multicenter, Randomized, Single Blind, Dose Finding Phase II Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 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 explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily 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 or their guardians are able to provide a written informed consent
- •Subjects have been treated with endotracheal intubation and mechanical ventilation, and is expected to receive sedation after randomization. The target level and duration of sedation meet the criteria
- •Meet the age criteria, male or female
- •Meet the BMI criteria
排除标准
- •Deep sedation is required, or continuous sedation is not needed during the study process
- •Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness
- •Subjects with a history of drug abuse
- •Subjects after neurosurgery operation
- •Organ failure before randomization
- •Abnormal values of the laboratory examination
- •Abnormal blood pressure and heart rate during screening
- •Allergic to relevant drugs ingredient or component
- •Pregnant or nursing women
- •Subjects who has participated in clinical trials of other interventions recently
研究组 & 干预措施
A：Remimazolam Tosilate
Experimental
干预措施: Remimazolam Tosilate (Drug)
B：Remimazolam Tosilate
Experimental
干预措施: Remimazolam Tosilate (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 subjects receiving rescue sedation and the average dosage of rescue sedation(within 24 hours after administration of research drug)
- Percentage of time maintaining target sedation in the entire drug administering time.(within 24 hours after administration of research drug)
- The number of times to change the infusion rate(within 24 hours after administration of research drug)
- Evaluation of nursing difficulty.(follow-up period (approx. 5-10 minutes))
- Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesiaassessment time point after drug administering.(within 24 hours after administration of research drug)
- Mechanical ventilation time.(at the time of extubation)
- Wake-up time.(within 8 hours after stopping the research drug)
研究者
研究点 (1)
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