Validity of Pain Threshold Index Based on Electroencephalogram for Pediatric Patients Under General Anesthesia
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Remifentanil consumption
研究概览
简要总结
Comparison of total infused dose of remifentanil between pain threshold index monitoring group and control group
详细描述
Investigators plan to enroll pediatric patients aged between 3 and 12 years old undergoing surgery under general anesthesia with continuous infusion of 2% propofol and remifentanil.
After dividing them into two groups, investigators monitor pain threshold index and wavelet index in test group and adjust remifentanil infusion to maintain both indices in desirable range, while monitoring only wavelet index and adjust remifentanil infusion to maintain wavelet index and conventional vital signs in desirable range in control group.
Investigators compare consumption of remifentanil, time to extubation after surgery, and post-anesthesia care unit length of stay between both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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 between 3 and 12 years old undergoing orthopedic surgery at extremities under general anesthesia
排除标准
- •History of adverse drug reactions to opioids
- •Underlying neurological disease or taking medication for neurologic purpose
- •Patients who were transferred to intensive care unit after the surgery
研究组 & 干预措施
Pain threshold index group
Adjust infusion rate of remifentanil and propofol according to pain threshold index and wavelet index in 'pain threshold index group'.
干预措施: Pain threshold index (Device)
Pain threshold index group
Adjust infusion rate of remifentanil and propofol according to pain threshold index and wavelet index in 'pain threshold index group'.
干预措施: Wavelet index (Device)
Control group
As conventional management, adjust infusion rate of remifentanil and propofol according to wavelet index and conventional vital signs
干预措施: Wavelet index (Device)
结局指标
主要结局
Remifentanil consumption
时间窗: At the end of anesthesia, total anesthesia time less than 1 day
Total amount of infused remifentanil divided by patient's weight and total anesthesia time
次要结局
- Post-anesthesia care unit length of stay(At discharge from post-anesthesia care unit, less than 1 day)
- Extubation time(At the end of anesthesia, less than 1 hour)
研究者
Hee-Soo Kim
professor
Seoul National University Hospital