Comparison of Pupillometry-guided With Surgical Pleth Index (SPI) Guided General Anesthesia on Perioperative Opioid Consumption and Pain Intensity: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 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 intraoperative opioid consumption and postoperative pain 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
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
研究组 & 干预措施
Pupillometry group
In this group, anesthesia is performed using Pupillometry guided anesthesia.
干预措施: Pupillometry guided anesthesia (Procedure)
SPI group
In this group, anesthesia is performed using SPI guided anesthesia.
干预措施: SPI guided anesthesia (Procedure)
Control group
In this group, remifentanil concentration is controlled by the discretion of the anesthesiologist in charge of the patients (Standard management).
干预措施: Standard management (Procedure)
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.
Intraoperative opioid consumption
时间窗: During the operation period (Within 2 hour after the anesthesia induction)
The amount of remifentanil consumption during the operation is calculated by following equation: Total remifentanil consumption (mcg) / body weight of the patients (kg)/ duration of anesthesia (min)
次要结局
- 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)
- Intraoperative propofol consumption(During the operation period (Within 2 hour after the anesthesia induction))
- Intraoperative vasopressor or vasodilator consumption(During the operation period (Within 2 hour after the anesthesia induction))
- PACU stay time(Approximately within 1 hour after the PACU admission)
- Total analgesic consumption after PACU discharge(During 1 day after the operation)
- initial Pupillary unrest under ambient light (PUAL)(Just before the induction of anesthesia)
- Pupillary unrest under ambient light (PUAL) on PACU arrival(Approximately within 1 min after the PACU admission)
研究者
Eugene Kim
Assistant professor
Daegu Catholic University Medical Center