Emergence Delirium in Pediatric Age Group: Comparison Between Sevoflurane and Intravenous Anesthesia in Hypospadias Repair: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Emergence delirium
研究概览
简要总结
Emergence agitation (EA), a phenomenon observed at the time of recovery from general anesthesia (GA).The cause of ED appears to be multifactorial in origin. Use of volatile anesthetics, prolonged duration and type of surgery, pain, and rapid emergence are some factors known to increase its incidence
详细描述
The pathogenesis of postoperative EA is still undefined, but sevoflurane has intrinsic effects that may share in emergence agitation like its different electroencephalogram pattern from halothane, and its degradation to inorganic fluoride ions and compound A which may have a role in the occurrence of EA Sevoflurane now is the inhalational anaesthetic agent of choice for pediatrics, as it is non-pungent, with minimal airway irritation characters, and its cardiac adverse effects are minimal like cardiac depression and dysrhythmias.
Total intravenous anesthesia (TIVA) using propofol and fentanyl appears to have a smooth recovery profile
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 1 to 8 years
- •American society of anesthesiologists (ASA) physical status I and II, scheduled for hypospadias repair
排除标准
- •children with a history of active airway disease,
- •sleep apnoea, developmental delay,
- •psychological,
- •neurological disorder,
- •cardiovascular abnormality or requirement of post-operative ventilation,
- •hepatic impairment, and renal insufficiency, with active upper respiratory tract infection
研究组 & 干预措施
sevoflurane group
Anesthesia was maintained with sevoflurane (1-1.2 MAC) with oxygen /air 1:1
干预措施: sevoflurane (Drug)
Propofol group
Anesthesia was maintained continuous infusion of 100-400 mcg/kg /min of propofol and fentanyl 0.1 ug / kg/ min with oxygen /air 1:1
干预措施: propofol (Drug)
结局指标
主要结局
Emergence delirium
时间窗: 24 hours
The pediatric anesthesia emergence delirium (PAED) scale. Each must be evaluated as not at all, just a little, quite a bit, very much, or extremely, where the first three items to be scored reversely (4 = not at all, 0 = extremely) while the last two items to be scored regularly.
次要结局
- FLACC(Postoperatively at 24 hours)
研究者
Ramy Mousa
Professor of Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt
Benha University