Effect of a Bolus of 10 µg/kg of Alfentanil on the Pupillary Pain Index
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change between Pupillary Pain Index before and after alfentanil bolus
研究概览
简要总结
This study aims to assess the Pupillary Pain Index before and after a bolus of alfentanil in children under general anesthesia, before skin incision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective surgery under general anesthesia
- •Written informed consent
排除标准
- •Chronic pain
- •Preoperative analgesic drug
- •Neurologic disease
- •Ophtalmic disease
研究组 & 干预措施
alfentanil
Children under general anesthesia for elective surgery. Induction with sevoflurane or propofol according to the preference of the patient.
Maintenance with sevoflurane. 5 minutes before skin incision, first assessment of the pupillary pain index. Then injection of 10 µg/kg of alfentanil. After 5 minutes second assessment of pupillary pain index. End of study period, beginning of surgery.
干预措施: Alfentanil (Drug)
alfentanil
Children under general anesthesia for elective surgery. Induction with sevoflurane or propofol according to the preference of the patient.
Maintenance with sevoflurane. 5 minutes before skin incision, first assessment of the pupillary pain index. Then injection of 10 µg/kg of alfentanil. After 5 minutes second assessment of pupillary pain index. End of study period, beginning of surgery.
干预措施: sevoflurane or propofol (Drug)
结局指标
主要结局
Change between Pupillary Pain Index before and after alfentanil bolus
时间窗: Five minutes before incision and just before incision. Each measure = 20 seconds
pupillometry
次要结局
未报告次要终点
研究者
Pr Isabelle CONSTANT
Professor
Hôpital Armand Trousseau