Effect of Pupilometer Guided Analgesia on Postoperative Pain Intensity and Perioperative Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Peak pain score assessed by numeric rating scale (NRS) in post-anesthesia care unit (PACU)
研究概览
简要总结
In this study, the investigators measure a pupil size every 5 minutes during the operation in patients undergoing laparoscopic cholecystectomy under general anesthesia. The investigators would compare the postoperative pain intensity between the group adjusted the anesthetic drug concentration based on the changes of the pupil (Pupil group) and the group based on the changes of a surgical pleth index (SPI group).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20 to 65 yr, American Society of Anesthesiologist Physical status(ASA PS) I to II, scheduled for a laparoscopic cholecystectomy under general anesthesia
排除标准
- •Presence of ophthalmologic diseases such as Horner's syndrome or Sjogren's disease.
- •Presence of neurologic or metabolic diseases
- •Medicated that could interfere with the autonomous nervous system (e.g., b- blockers, anticholinergics)
- •History of substance abuse or psychiatric disease with chronic pain or preoperative analgesics with pacemaker or arrhythmia
结局指标
主要结局
Peak pain score assessed by numeric rating scale (NRS) in post-anesthesia care unit (PACU)
时间窗: During the PACU stay (Within 1 hour after the PACU admission)
Patients are asked to rate their pain according to the numeric rating scale (NRS, 0=no pain to 10= extreme pain imaginable) every 10 min after the PACU admission. Peak pain score is the peak NRS during PACU stay. Higher NRS represents a worse outcome.
次要结局
- Intraoperative mean SPI(Approximately during 2 hour after the anesthesia induction)
- Total analgesic consumption after PACU discharge(During 1 day after the operation)
- Intraoperative propofol consumption(During the operation period (Within 2 hour after the anesthesia induction))
- Intraoperative remifentanil consumption rate(During the operation period (Within 2 hour after the anesthesia induction))
- Postoperative adverse events(Approximately within 1 hour after the PACU admission)
- Remnant sedation degree(Approximately within 1 hour after the PACU admission)
- Pain score assessed by numeric rating scale (NRS) 1 day after the operation(On 1 day after the operation)
研究者
JongHae Kim
Associate professor
Daegu Catholic University Medical Center