Effects of Analgesia Nociception Index (ANI)-Guided Analgesia on Postoperative Bowel Function Recovery in Laparoscopic Colorectal Surgery: A Prospective Randomized-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time to first gas passing from surgery
研究概览
简要总结
Investigators will examaine the effects of Analgesia Nociception Index (ANI)-guided analgesia on postoperative bowel function recovery in laparoscopic colorectal surgery. This is a prospective randomized-controlled study.
Investigators will randomly divide the patients into two groups. In ANI group, remifentanil infusion rate during anesthesia will be adjusted according to ANI monitoring. In Control group, remifentanil infusion rate during anesthesia will be adjusted according to the conventional method of blood pressure and heart rate monitroing. And Investigators will evalualte the bowel function recovery in both groups after surgery, and compare between the two groups.
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
- Single (Participant)
盲法说明
Patients don't know which group they belong to.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 19 years who undergo laparoscopic colorectal surgery for colorectal cancer at Gangnam Severance Hospital, Seoul, South Korea.
排除标准
- •Emergency surgery
- •Patients undergoing colostomy
- •Patients with history of open abdominal surgery
- •Patients with arrhythmia
- •Patients with pacemaker insertion
- •Patients with history of heart transplantation
- •Patients taking medications that may affect ANI (antimuscarinics, alpha-agonists, beta blockers)
- •Patients with chronic opioid medication.
- •Cognitive impairment
- •Unable to read consent form (eg illiterate, foreigner, etc.)
结局指标
主要结局
Time to first gas passing from surgery
时间窗: Up to postoperative 2weeks
Time (hours) to first gas passing from surgery
次要结局
- Postoperative opioid consumption(postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days.(Minimum value: 0, Maximum value: 10, higher score means worse.))
- Time to starting fluid intake from surgery(up to 2weeks)
- Time to first rescue analgesics from surgery(up to 2weeks)
- Time to starting soft diet from surgery(up to 2 weeks)
- Nausea score(postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days)
- Number of vomiting, antiemetic administration(up to 2weeks)
- Time to starting ambulation from surgery.(up to 2 weeks)
- QoR-15(postoperative 1days, 4days)
- Plasma concentration of Cortisol, Norepinephrine, Epinephrine, IL-6(immediately after surgery)
- Intraoperative opioid consumption(during anesthesia)
- Pain score(postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days.(Minimum value: 0, Maximum value: 10, higher score means worse.))
- Hemodynamics during anesthesia(during anesthesia)
研究者
Young Song
Associate Professor
Gangnam Severance Hospital