Comparison of Propofol 1mg/kg and Propofol 0.5mg/kg for Prevention of Emergence Agitation in Children Undergoing Strabismus Surgery During Sevoflurane Anesthesia
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The incidence of the emergence agitation
研究概览
简要总结
The occurrence of emergence agitation (EA) in pediatric patients who have received sevoflurane anesthesia is a common postoperative problem. Among various strategies for reducing the incidence and severity of EA, the use of pharmacological agents at the end of anesthesia is thought to be the most convenient and easily applicable method in clinical situation. The one of typical agents that can be administered in this way is propofol. Previous studies demonstrated that the use of propofol 1mg/kg at the end of anesthesia could reduce the incidence of EA with low incidence of postoperative nausea and vomiting. However, it was also demonstrated that the use of propofol 1mg/kg at the end of anesthesia could delay the emergence time. The purpose of this study is to compare the preventive effect on EA and the emergence time between propofol 1mg/kg and propofol 0.5mg/kg administered at the end of sevoflurane anesthesia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children (3-12 years old) scheduled for elective strabismus surgery undergoing general anesthesia.
排除标准
- •Patients with developmental disability, mental retardation, neurologic disorder, ongoing neurologic medication such as anticonvulsant, previously undergoing general anesthesia, a recent history of upper respiratory infection, parents difficult to read or understand the informed consent.
研究组 & 干预措施
1) propofol 1.0mg/kg group
According to randomly allocated group, propofol 1.0mg/kg, propofol 0.5mg/kg or normal saline will be intravenously administered at the end of surgery
干预措施: Injection of propofol 1.0mg/kg (Drug)
2) propofol 0.5mg/kg group
According to randomly allocated group, propofol 1.0mg/kg, propofol 0.5mg/kg or normal saline will be intravenously administered at the end of surgery
干预措施: propofol 0.5mg/kg (Drug)
3) normal saline group
According to randomly allocated group, propofol 1.0mg/kg, propofol 0.5mg/kg or normal saline will be intravenously administered at the end of surgery
干预措施: normal saline (Drug)
结局指标
主要结局
The incidence of the emergence agitation
时间窗: from extubation up to 1 hour
次要结局
- the emergence time(within the first 1hour after end of strabismus surgery)