Effects of Analgesia Nociception Index (ANI)-Guided Intraoperative Analgesia on Postoperative Pain: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- the incidence of moderate-to-severe postoperative pain
研究概览
简要总结
This study evaluates the effects of Analgesia Nociception Index (ANI)-guided intraoperative analgesia on postoperative pain in patients undergoing open gynecologic surgery.
详细描述
Postoperative pain is one of the most common postoperative complications and is significantly associated with patient's quality of recovery. Analgesia Nociception Index (ANI) is known to analyze the high frequency component of heart rate variability in relation to respiratory frequency, providing the objective information on the degree of pain. However, most previous studies conducted by using ANI were observational studies or small-sized randomized controlled studies. In the present study, the investigators aimed to evaluate the effects of ANI-guided intraoperative analgesia on moderate-to-severe postoperative pain by performing randomized controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective open gynecological surgery
- •American Society of Anaesthesiologists physical status classification 1-3
排除标准
- •Laparoscopic surgery or robot-assisted surgery
- •Patients who had analgesic agents, anti-psychotic agents, anticonvulsants which were related to chronic pain
- •Patients who had hypersensitivity to analgesic agents or medications related anesthesia.
- •Patients who were required to have mechanical ventilation after surgery
- •Patients who had arrhythmia
- •Patients who transferred to the surgical intensive care unit immediately after surgery
- •Pregnancy
结局指标
主要结局
the incidence of moderate-to-severe postoperative pain
时间窗: during 1 hour of stay in the postanesthesia care unit
the incidence of moderate-to-severe postoperative pain is defined as a case in which pain with numeric rating scale (NRS) of 5 or more is reported during stays in the postanesthesia care unit. Pain assessment is performed two times during stays in the postanesthesia care unit.
次要结局
- the amount of intraoperative remifentanil(intraoperative)
- Quality of Recovery-15 (QoR-15) score(at postoperative 24 hour)
- 11-pointed NRS pain score(at postoperative 24 hour)
- the incidence of postoperative nausea and vomiting(at postoperative 1 hour, 24 hour, 72 hour)
研究者
Hee-Soo Kim
Professor
Seoul National University Hospital