The Effect of Intravenous Fentanyl Prior the End of Surgery on Emergence Agitation in Paediatric Patients After General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- the incidence of emergence agitation
研究概览
简要总结
The propose of this study is to determine the effect of intravenous fentanyl prior the end of surgery on the incidence and severity of EA in pediatric patient.
详细描述
Emergence agitation (EA) is a common self limiting problem after emerging from general anesthesia (GA) especially in pediatric patients. The incidence of EA in Thai population, the incidences of EA 43.2% in pediatric patients aged between 2-9 years. There have been many studies tried to reduce the incidence of EA in various ways such as Preoperative anxiety reduction method and medication. Premedication, Sedative drugs and narcotic drugs were used to reduce the incidence of EA.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 2-9 years
- •IPD patient
- •Receiving Chloral hydrate 50mg/kg (BW<20 kgs)or midazolam 0.1 mg /kg (BW>20 kgs)Per oral for premedication
- •Scheduled for one kind of these surgeries; Otolaryngology, Ophthalmology, Urology, Orthopedic,General surgery, Plastic surgery and Cardiac catheterization.
排除标准
- •ASA physical status IV-V
- •History of drug allergy:thiopental, fentanyl cisatracurium, chloral hydrate and diazepam
研究组 & 干预措施
fentanyl group
First arm: intervention group. Patient in this group received fentanyl 1 mcg/kg (concentration 10mcg/ml) intravenous route 15 minutes before the end of surgery.
干预措施: fentanyl (Drug)
controlled group
patient in this group received NSS 0.1 ml/kg 15 minutes before the end of surgery
干预措施: NSS (Drug)
结局指标
主要结局
the incidence of emergence agitation
时间窗: pt was observed since emerging from anesthesia up to 60 minutes
次要结局
- severity of emergence agitation(pt was observed since emerging from anesthesia up to 60 minutes)
- adverse effect from intravenous fentanyl prior the end of surgery(pt was observed since emerging from anesthesia upto 60 minutes)
- post operative pain(pt was observed since emerging from anesthesia up to 60 minutes)
研究者
Ngamjit Pattaravit
Doctor
Prince of Songkla University