Remimazolam Besylate Versus Propofolfor Sedation of Postcardioperative Patients in Intensive Care Unit: a Prospective,Single-center,Randomized Non-inferior Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- percentage of time in the target sedation range
研究概览
简要总结
Intensive care medicine is vital in managing patients after cardiac surgery with endotracheal intubation，in order to provide extensive monitoring to assure clinical stabilization. During this time of recovery, sedation is frequently employed. However, prolonged sedation risks negative sequelae.At present,propofol, benzodiazepines, and dexmedetomidine are typical drugs used for sedation of patients in intensive care unit.Each has its own advantages and disadvantages.The investigators try to find near-ideal agents for sedation,characterized by good sedative effect,minimal adverse effects and rapid awakening facilitating earlier extubation.Remimazolam appeared to be an effective and safe sedative for short term sedation. Study participants were predicated on age (> 18 years), admission following cardiac surgery, still mechanical ventilation within 48 hours,and prior informed consent.Participants were randomized to receive remimazolam besylate or propofol in a 1:1 ratio for sedation with a target sedation depth before extubation.Finally，the investigators will compare the sedation effect and safety between the 2 groups ，to prove if remimazolam is appropriate for sedation in patients after cardiac surgery in intensive care unit.
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
- Single (Participant)
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 ;
- •admitted to the intensive care unit after cardiac surgery with techanical ventilation；
- •expected to extubation within 48hours ；
- •participant has given informed consent
排除标准
- •pregnant or lactating women
- •known or suspected hypersensitivity to the study drug
- •history of impaired consciousness or psychiatric illness
- •severe bradycardia with a heart rate of < 50 beats per minute
- •systolic blood pressure < 90 mmHg with fluid resuscitation and vasopressor maintenance
- •atrioventricular block（II or III degree）, Left ventricular ejection fraction(LVEF) <30%
- •participated in other clinical studies within 3 months
研究组 & 干预措施
Remimazolam group
干预措施: Remimazolam (Drug)
propofol group
干预措施: Propofol (Drug)
结局指标
主要结局
percentage of time in the target sedation range
时间窗: up to 2 days
The primary outcome was the percentage of time in the target sedation range without rescue sedation.
次要结局
- extubation time(up to 2 days)
- extubation success rate(up to 4 days)
- changes in blood pressure(up to 2 days)
- changes in heart rate(up to 2 days)
- ventilator-free days(From enrollment to 7 days)
- the score of confusion assessment method for the intensive care unit ( CAM-ICU)(From enrollment to the end of treatment at 28 days)
- stay length(From enrollment to the end of treatment at 28 days)
- 28-day mortality(From enrollment to the end of treatment at 28 days)