NCT05782894已完成3 期
A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Injection for Sedation in ICU Patients
Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2023年2月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Successful sedation
研究概览
简要总结
A randomized non-inferior trial comparing remimazolam besylate with propofol for short-term sedation during invasive mechanical ventilation in intensive care units
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
- •Body mass index (BMI) ≥18 and ≤ 30 kg/m2
- •Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on ventilator for at least 6 hours
- •Requirement for light to moderate sedation (a Richmond agitation-sedation scale score of -2 to 1)
排除标准
- •Refusal to be included
- •Allergy or unsuitability to any composition of study drugs or remifentanil
- •Living expectancy less than 48 hours
- •Myasthenia gravis
- •Status asthmaticus
- •Abdominal compartment syndrome
- •Serious hepatic dysfunction (CTP 10-15);
- •Chronic kidney disease with glomerular filtration rate (GFR) < 29 ml/min/1.73m2
- •Mean blood pressure less than 65 mm Hg or the need of a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain Mean blood pressure ≥ 65 mm Hg
- •Possible requirement for surgery or bedside tracheostomy in 24 hours
- •Possible requirement for renal replacement therapy in 24 hours
- •Acute severe neurological disorder and any other condition interfering with sedation assessment
- •Abuse of controlled substances or alcohol
- •Pregnancy or lactation
- •Inclusion in another interventional trial in the past 30 days
- •Other conditions deemed unsuitable to be included
研究组 & 干预措施
Remimazolam besylate
Experimental
Remimazolam besylate
干预措施: Remimazolam besylate (Drug)
Remimazolam besylate
Experimental
Remimazolam besylate
干预措施: Remifentanil (Drug)
Propofol
Active Comparator
Propofol
干预措施: Propofol (Drug)
Propofol
Active Comparator
Propofol
干预措施: Remifentanil (Drug)
结局指标
主要结局
Successful sedation
时间窗: 24 hours
70% of time in the target sedation range in participants without rescue sedation
次要结局
- The percentage of time in the target sedation range without rescue sedation(24 hours)
- Number of patients needing rescue sedation(24 hours)
- The amount of remifentanil in ug/kg/h(24 hours)
- Number of patients needing repeated boluses of the study drug(24 hours)
研究者
研究点 (1)
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