2022-501124-23-00
招募中
3 期
« Effect of sedative and anxiolytic sedation on children experience after general anesthesia » PEDIA_prem study.
概览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 10
- 主要终点
- The primary endpoint was the EVANpedia perioperative experience score and its sub-dimensions completed by the children (self-report) at 24 hours postoperatively or before hospital discharge for children managed as outpatients.
概览
简要总结
The aim of this prospective randomized clinical trial is to assess the impact of pharmacologic premedication on perioperative children experience.
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomization group
- 盲法
- Double (Subject, Investigator)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Children older than 7 years old and younger than 18 years old
- •Subject to undergo surgery under general anesthesia
- •Subject able to complete a self-questionnaire
- •Subject requiring intervention under general anesthesia
排除标准
- •Subject suffering from anxiety disorders
- •Subject who is not affiliated with or benefiting from a social security plan
- •Subject suffering from cognitive disorders
- •Subject suffering from chronic pain
- •Subject with ADD (Attention Deficit Disorder) with or without hyperactivity; with or without treatment
- •Subjects suffering from mental retardation
- •Subjects receiving psychotropic treatment
- •Subjects whose ability to complete a self-administered questionnaire may be impaired by the intervention
- •Subject with a contraindication to midazolam or to dexmedetomidine
- •Subjects requiring peri-operative alpha agonist
结局指标
主要结局
The primary endpoint was the EVANpedia perioperative experience score and its sub-dimensions completed by the children (self-report) at 24 hours postoperatively or before hospital discharge for children managed as outpatients.
The primary endpoint was the EVANpedia perioperative experience score and its sub-dimensions completed by the children (self-report) at 24 hours postoperatively or before hospital discharge for children managed as outpatients.
次要结局
- Perioperative anxiety
- Haemodynamic changes (Tachycadia, Bradycardia hypotension) during intervention, postoperative pain
- Sedation and time to extubation
- Rate of recovery
- Amnesia and cognitive impairment
- Changes of behavioral
- All perioperative complications between the 3 groups
- Quality of life
研究者
Sophie BRINGUIER
Scientific
University Hospital Of Montpellier
研究点 (10)
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