Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Critically Ill Patients With Deep Sedation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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 besylate compared to propofol for sedation in critically ill patients with deep sedation.
详细描述
This is a single-center, prospective, randomized, controlled study using remimazolam besylate and propofol for sedation in critically ill patients with deep sedation. 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 80 years;
- •Expected to require deep sedation ≥8 hours;
- •Requirement for deep sedation (a Narcotrend index between 13 and 64).
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;
- •Expected to have a general anesthesia within 8 hours;
- •Pregnancy or lactation.
研究组 & 干预措施
Remimazolam Besylate
Patients in the remimazolam group received remimazolam besylate at an initial infusion rate of 0.3 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64.
干预措施: Remimazolam Besylate (Drug)
Propofol
Patients in the propofol group received propofol at an initial infusion rate of 3.0 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64.
干预措施: Propofol (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 discharged from our ICU, the sedation target was changed, 48 hours after enrollment, or dead, whichever came first
The percentage of time in the target sedation range without rescue sedation
次要结局
- 7-day ventitlator free time(From start of study to 7 days)
- Extubation at day 7(From start of study to 7 days)
- Length of ICU stay(From start of study to 28 days)
- 28-day mortality(From start of study to 28 days)
- Adverse events(From the beginning of using study sedatives until being discharged from our ICU, the sedation target was changed, 48 hours after enrollment, or dead, whichever came first)
研究者
Xiaobo Yang, MD
MD
Wuhan Union Hospital, China