Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients: a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The percentage of time in the target sedation range 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 compared to propofol for sedation in mechanically ventilated ICU patients.
详细描述
This is a single-center, prospective, randomized, controlled pilot study using remimazolam and propofol for sedation in mechanically ventilated ICU patients. Subjects are randomized to remimazolam group and propofol group in a 1:1 ratio. Remifentanil is administered as the analgesic. Efficacy and safety profiles of remimazolam besylate are to be evaluated.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 75 years;
- •Intubated and mechanically ventilated ≤96 hours before enrollment；
- •Expected to require continuous invasive ventilation and sedation ≥24 hours;
- •Requirement for light to moderate sedation (a RASS score of -3 to 0).
排除标准
- •Body mass index (BMI) <18 or >30 kg/m2;
- •Acute severe neurological disorder and any other condition interfering with RASS assessment;
- •Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors;
- •Heart rate less than 50 beats/min;
- •Second- or third-degree heart block in the absence of a pacemaker;
- •Unstable angina;
- •Acute myocardial infarction;
- •Left ventricular ejection fraction less than 30%;
- •Contraindicate or allergic to study drugs;
- •Moribund state;
- •Acute hepatitis or serious hepatic dysfunction (Child-Pugh class C);
- •Chronic kidney disease with glomerular filtration rate (GFR) < 60 ml/min/1.73m2;
- •Alcohol abuse;
- •Myasthenia gravis;
- •Pregnancy or lactation.
研究组 & 干预措施
Propofol
Patients in the propofol group received propofol at an initial infusion rate of 2.0 mg/kg/h and adjusted to maintain a RASS score of -3 to 0.
干预措施: Sedation drugs (Drug)
Remimazolam
Patients in the remimazolam group received remimazolam besylate at an initial infusion rate of 0.15 mg/kg/h and adjusted to maintain a RASS score of -3 to 0.
干预措施: Sedation drugs (Drug)
结局指标
主要结局
The percentage of time in the target sedation range without rescue sedation
时间窗: From the beginning of using study sedatives until being extubated, being discharged from our ICU, the study drug was stopped for 24 hours by physicians, or 7 days after enrollment, whichever came first
The percentage of time in the target sedation range without rescue sedation
次要结局
- Length of ICU stay(From start of study to 28 days)
- 28-day mortality(From start of study to 28 days)
- 7-day ventitlator free time(From start of study to 7 days)
研究者
Xiaobo Yang, MD
MD
Wuhan Union Hospital, China