NCT06124404已完成2 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 36 人开始时间: 2022年4月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 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
This is a Phase II, dose-escalation clinical trial conducted in mechanically ventilated patients receiving sedation no longer than 24 hours. The efficacy, safety, and pharmacokinetics of remimazolam besylate were evaluated using a randomized, single-blind design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Body mass index (BMI) ≥18 and ≤ 30 kg/m2
- •Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on a 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 for 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
研究组 & 干预措施
Small dose
Experimental
干预措施: Remimazolam besylate (Drug)
Medium dose
Experimental
干预措施: Remimazolam besylate (Drug)
Large dose
Experimental
干预措施: Remimazolam besylate (Drug)
结局指标
主要结局
The percentage of time in the target sedation range without rescue sedation
时间窗: Within 24 hours while receiving the study drug
The percentage of time in the target sedation range without rescue sedation
次要结局
- The number and severity of treatment emergent adverse events (TEAEs)(Within 48 hours after the stop of the study drug)
研究者
研究点 (1)
Loading locations...
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