Efficacy and Safety of Remimazolam for Sedation in ICU Patients Undergoing Mechanical Ventilation: a Single Center, Randomized, Controlled, Non-inferiority Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 488
- 主要终点
- the duration of mechanical ventilation
研究概览
简要总结
Sedation is a component of the care of critically ill patients who are undergoing mechanical ventilation. Dexmedetomidine induces sedation while preserving a degree of arousability among patients in the intensive care unit (ICU), and its use has resulted in a shorter time to extubation, an increased number of days free from coma or delirium, a reduced incidence of agitated delirium, prevention of delirium, and lower mortality than other agents administered in certain populations. Hypotension and bradycardia are common side effects, which is lethal for the patients with persistent or severe hemodynamic instability.
The pharmacological properties of rimazolom suggest that it is an ideal sedative drug for critically ill patients, but there is no relevant clinical research to confirm it. Therefore, this study mainly discusses the efficacy and safety of remidazolam in ICU patients with mechanical ventilation, so as to provide theoretical basis for individualized sedation treatment of patients with mechanical ventilation.
详细描述
- Title: Efficacy and Safety of Remimazolam for Sedation in ICU Patients Undergoing Mechanical Ventilation
- Research center: Single Center
- The Design of the study: Randomized, Controlled, Non-inferiority Trial
- The population of the study: The main inclusion criteria are 18 years old or above, invasive mechanical ventilation is required, and the clinical need is mild to moderate Sedated (RASS score 0 to -3) patients
- Sample size: Enroll 488 patients (244patients in each group)
- Interventions: Participants in the test group received remimazolam for sedation, while participants in the control group received dexmedetomidine, The analgesia drug in two group is fentanyl.
- The aim of the research: To investigate the efficacy and safety of remimazolam for sedation in ICU patients undergoing mechanical ventilation
- Outcome# 1) Primary outcome# the ratio of the time to reach the target sedation (RASS score, 0 to -3)in the total duration of drug infusion, and the duration of mechanical ventilation. 2)Secondary outcome#; Length of stay in ICU and Length of stay in hospital; Incidence of complications (including re-hospitalization); Total expenses during hospitalization
- The estimated duration of the study#2-3years
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main inclusion criteria are 18 years old or above, invasive mechanical ventilation is required, and the clinical need is mild to moderate Sedated (RASS score 0 to -3) patients.
排除标准
- •Refuse to participate in this study
- •Patients with severe bradycardia (HR<50 bpm)
- •Patients who is pregnancy
- •Patients with brain injury or neurosurgery
- •Patients receiving sedation for treatment indications (such as epilepsy), not to tolerate a ventilator.
- •Patients receiving any study medication within 30 days
研究组 & 干预措施
Experimental group
Participants in the experimental group received remimazolam for sedation
干预措施: Remimazolam (Drug)
Control group
participants in the control group received dexmedetomidine for sedation
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
the duration of mechanical ventilation
时间窗: average of 1-2 year
Duration of mechanical ventilation in ICU
Time to reach targeted sedation goals
时间窗: an average of 1-2 year
the ratio of the time to reach the target sedation (RASS score, 0 to -3) in the total duration of drug infusion
次要结局
- Length of stay in hospital(2 years)
- Length of stay in ICU(about 2 years)
- Total expenses during hospitalization(24 months)
研究者
Jianbo Yu
Department of Anesthesiology and Critical Care Medicine
Tianjin Nankai Hospital