Comparison Between Propofol and Fentanyl for Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- The incidence of 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. The prevalence of EA varies between 10% to 80% depending on the scoring system for evaluation and the anesthetic technique used.
Many authors reported various strategies such as use of sedative premedication, change of maintenance technique of anesthesia, or pharmacological agents administered at the end of anesthesia to reduce the incidence and severity of EA, and to allow a smooth emergence from sevoflurane anesthesia. Among these strategies, the use of pharmacological agents at the end of anesthesia is not affected by anesthetic duration, and may not prolong recovery duration of anesthesia excessively when these agents are administered as subhypnotic or small dose. The typical agents that can be administered in this way are propofol and fentanyl.
Previous studies demonstrated that the use of either propofol or fentanyl at the end of anesthesia could reduce the incidence of EA.
The purpose of this study is to compare the preventive effect on EA and the characteristics of anesthesia recovery between propofol and fentanyl 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
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Months 至 72 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists I or II,
- •18-72 months of age,
- •scheduled for ambulatory inguinal hernia repair undergoing general sevoflurane anesthesia
排除标准
- •developmental delay
- •psychological and neurologic disorder
- •sedatives medication
- •an abnormal airway
- •reactive airway disease
- •extreme agitation and uncooperation
- •previous history of anesthesia
研究组 & 干预措施
Propofol group
intravenous administration of propofol 1 mg/kg at the end of anesthesia
干预措施: Administration of propofol (Drug)
Fentanyl group
intravenous administration of fentanyl 1 mcg/kg at the end of anesthesia
干预措施: Administration of fentanyl (Drug)
Control group
intravenous administration of saline at the end of anesthesia
干预措施: Administration of saline (Drug)
结局指标
主要结局
The incidence of emergence agitation
时间窗: Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of one hour.
The investigator will evaluate the incidence and extent of emergence agitation of participants, according to Aono's scale, the 5-step Emergence Agitation (EA) scale. Also, the Pediatric Anesthesia Emergence Delirium (PAED) scale will be used to assess emergence agitation. Aono's scale scores ≥3, 5-step (EA) scale ≥4 or PAED scale scores ≥10 will be considered as presence of emergence agitation
次要结局
未报告次要终点