The Effect of Remifentanil Infusion During Emergence on the Incidence of Emergence Delirium After Sevoflurane Anesthesia in Pediatric Strabismus Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- the scale of emergence agitation
研究概览
简要总结
The aim of the present study is to assess the effect of postoperative remifentanil infusion on the incidence of emergence agitation in preschool-aged children undergoing strabismus surgery with sevoflurane anaesthesia.
详细描述
Patients are randomly assigned to one of two groups. Anesthesia is maintained with sevoflurane and remifentanil infusion. All patients received a predetermined concentrations of remifentanil according to their group assignments (control group, remifentanil 0 ug/kg/min; remifentanil group, remifentanil 0.05 ug/kg/min) from 10 minutes before the end of surgery to discharge from postanesthetic care unit. emergence agitation is assessed during the emergence phase.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status I and II
- •preschool-aged children undergoing strabismus surgery
排除标准
- •psychological disorders
- •emotional disorders
- •abnormal cognitive development
- •developmental delay
- •allergy to the drugs in our protocol
研究组 & 干预措施
remifentanil group
Remifentanil 0.05 ug/kg/min is infused to the patients.
干预措施: Remifentanil (Drug)
control
Normal saline 0.2 ml/kg/hour is infused to the patients
干预措施: Placebo (Drug)
结局指标
主要结局
the scale of emergence agitation
时间窗: up to 30 minutes after arrival in postanesthetic care unit, and 30 minutes after discharge from postanesthetic care unit.
A blinded observer record emergence agitation at just after laryngeal mask removal, 5 minutes after arrival in postanesthetic care unit, 10 minutes after arrival in postanesthetic care unit, 15 minutes after arrival in postanesthetic care unit, 30 minutes after arrival in postanesthetic care unit, and 30 minutes after discharge from postanesthetic care unit.
次要结局
- the effect of remifentanil on the emergence(up to 30 minutes after the discharge form postanesthetic care unit)
研究者
Sangjin Park
assistant professor
Yeungnam University College of Medicine