A Prospective Randomized Study Evaluating Pupillometry Guided Remifentanil Administration in Pediatric Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- peroperative remifentanil consumption
研究概览
简要总结
The aim of this prospective randomized study is to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in pediatric anesthesia. All patients are anesthetized with sevoflurane and remifentanil. In the intervention group, peroperative remifentanil infusion rate is guided by pupillometry. In the other group, remifentanil infusion rate is guided according to hemodynamic data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children scheduled for a surgery lasting more than 90 minutes.
排除标准
- •Contraindication to sevoflurane, to remifentanil or to morphine.
- •Peripheral or central nerve block during and after surgery.
- •Ophthalmological disease.
- •Peroperative position with no acess to the head.
- •Chronic use of medication interfering with pupillary diameter.
- •Ambulatory surgery
研究组 & 干预措施
Standard practice
Remifentanil infusion guided by usual clinical signs (heart rate, blood pressure).
Pupillometry blindly recorded. Anesthesia maintenance with sevoflurane.
干预措施: Remifentanil (Drug)
Standard practice
Remifentanil infusion guided by usual clinical signs (heart rate, blood pressure).
Pupillometry blindly recorded. Anesthesia maintenance with sevoflurane.
干预措施: Sevoflurane (Drug)
Pupillometry
Remifentanil infusion guided by changes in pupillary diameter. Anesthesia maintenance with sevoflurane.
干预措施: Remifentanil (Drug)
Pupillometry
Remifentanil infusion guided by changes in pupillary diameter. Anesthesia maintenance with sevoflurane.
干预措施: Pupillometry (Device)
Pupillometry
Remifentanil infusion guided by changes in pupillary diameter. Anesthesia maintenance with sevoflurane.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
peroperative remifentanil consumption
时间窗: duration of surgery
次要结局
- Pain scoring (verbal numerical scale)(during the 24 hour post operative period)
- Pain scoring (questionnaire)(one month post-operatively)
- Incidence of morphine side effects(during the 24 hour post operative period)
- Morphine consumption(during the 24 hour post operative period)
研究者
Walid HABRE
Professor
University Hospital, Geneva