NCT05913336已完成1 期
Evaluating the Efficacy and Safety of Remimazolam Tosilate for Injection for Prolonged Mechanical Ventilation Sedation in the Intensive Care Unit (ICU) - A Non-randomized, Multicenter, Single-arm, Open-label, Proof-of-concept, Phase I/II Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 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 prolonged sedation(≥72h) during mechanical ventilation in the ICU.
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 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
- •Age ≥ 18 and ≤ 80 years, male or female
- •Body mass index (BMI) > 18 and < 30 kg/m2
排除标准
- •participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation；
- •Suffering from mental disorders (such as schizophrenia, depression, etc.) and cognitive dysfunction;
- •Organ failure during screening period；
- •Subjects who were receiving dialysis during the screening period or who were expected to require dialysis treatment during the study period;
- •History of epilepsy or status epilepticus;
- •Subjects with a history of drug abuse；
- •Myasthenia gravis or a history of myasthenia gravis;
- •severe arrhythmias or heart disease;
- •Subjects after neurosurgery operation；
- •participants who did not require continuous sedation during mechanical ventilation for endotracheal intubation;
- •Abnormal values of the laboratory examination
- •Subjects who required vasopressor medication to maintain normotensive blood pressure during the screening period (excluding subjects who used vasopressor medication only during surgery);
- •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
Experimental
IV of Remimazolam Tosilate
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 72 hours after administration of research drug
次要结局
- Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesia(within 72 hours after administration of research drug)
- Mechanical ventilation time.(at the time of extubation)
- Evaluation of nursing difficulty.(follow-up period (approx. 5-10 minutes))
- Wake-up time.(after stopping the research drug)
- Percentage of subjects receiving rescue sedation and the average dosage of rescue sedation(within 72 hours after administration of research drug)
- Percentage of time maintaining target sedation in the entire drug administering time.(within 72 hours after administration of research drug)
研究者
研究点 (1)
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