Analgesia-Nociception Index Guided Intraoperative Remifentanil Administration Versus Standard Practice : Evaluation of Perioperative Opioid Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Intraoperative remifentanil consumption
研究概览
简要总结
This study compares two groups of patients undergoing a gynecological surgey under general anesthesia: one group in which intraoperative analgesia is guided by the Analgesia-nociception index, and another group in which intraoperative analgesia is managed as in standard practice. The objective is to assess if the Analgesia Nociception Index may result in a decrease in total analgesic drugs consumption, a decrease in post-operative pain and in chronic pain development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective gynecological surgery under general anesthesia
- •Duration of surgery 1-7 hours
- •Duration of hospital stay > 24 hours
排除标准
- •chronic pain
- •chronic analgesic medication
- •neurologic disease
- •psychiatric disease
- •history of addiction
- •kidney or liver failure
- •allergy to any anesthetic or analgesic drug
- •BMI > 35
研究组 & 干预措施
Analgesia Nociception Index
Intraoperative remifentanil administration guided by the Analgesia Nociception Index
干预措施: Analgesia Nociception Index (Device)
Usual practice
Intraoperative remifentanil administration managed in standard practice
干预措施: Remifentanil (Drug)
结局指标
主要结局
Intraoperative remifentanil consumption
时间窗: up to 7 hours after the beginning of general anesthesia
total dose of remifentanil administered to the patient during general anesthesia
次要结局
- Postoperative morphine consumption(obtained 24 hours after the end of general anesthesia)
- Persistent pain(Obtained three months after surgery)