NCT06419543已完成不适用
Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy: Incidence, Characters and Its Impact on Prognostic Outcomes-- a Randomized, Controlled Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 333
- 试验地点
- 1
- 主要终点
- incidence of paradoxical reaction
研究概览
简要总结
Exploring the effect of remimazolam dose on paradoxical reactions in pediatric painless gastrointestinal endoscopy.
详细描述
Exploring the effect of remimazolam dose on paradoxical reactions and sedation in pediatric painless gastrointestinal endoscopy, observing the performance and duration of paradoxical reactions, and analyze the factors.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1-12 years old
- •ASA I-II level
- •Sign an informed consent form
排除标准
- •Developmental delay or neurological and psychiatric disorders
- •Severe malnutrition or severe obesity
- •High risk of stomach fullness and reflux aspiration
- •Allergic to benzodiazepines and opioids
- •Those who have taken sedative, analgesic, or antidepressant drugs within 24hours
- •Severe sleep apnea
- •Abnormal liver and kidney function
- •Recently participated in other clinical studies
研究组 & 干预措施
Group R1
Experimental
The first induction dose of remimazolam is 0.1mg/kg.
干预措施: Remimazolam (Drug)
Group R2
Experimental
The first induction dose of remimazolam is 0.2mg/kg.
干预措施: Remimazolam (Drug)
Group R3
Experimental
The first induction dose of remimazolam is 0.3mg/kg.
干预措施: Remimazolam (Drug)
结局指标
主要结局
incidence of paradoxical reaction
时间窗: 2 minutes after first infusion of remimazolam
observe the incidence of paradoxical reaction within 2 minutes
次要结局
- time records(1 day)
- performance and duration of paradoxical reaction(2 minutes after first infusion of remimazolam)
- dosage of sedative drugs(First infusion until end of remimazolam administration)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](1 day)
研究者
研究点 (1)
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