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临床试验/NCT03585088
NCT03585088已完成不适用

Can we Predict Postoperative Analgesic Requirement by Intraoperative Nociception?

Samsung Medical Center2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2018年6月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
2
主要终点
The correlation of requirement of postoperative analgesics for postoperative 24 hours and intraoperative nociception score

研究概览

简要总结

If the individual patient's pain is assessed and the amount of analgesic needed after surgery is predicted, appropriate injection of pain control and excessive injection of narcotic analgesic can be prevented. Therefore, investigators try to evaluate the degree of pain during surgery and the amount of analgesic use for management of postoperative pain.

详细描述

Post-operative pain not only alleviates patient discomfort, but also delays recovery and thus prolongs the hospital stay. There are many ways to control postoperative pain, but analgesic infusion through venous route, patient controlled analgesia (PCA), especially narcotic analgesics, is often used to control the infusion when needed. However, because PCA is based on only age, weight, and underlying diseases, there are limitations in effective analgesia, and excessive sedation due to excessive infusion. Therefore, if the individual patient's pain is assessed and the amount of analgesic needed after surgery is predicted, appropriate injection of pain control and excessive injection of narcotic analgesic can be prevented. The noxious stimuli during surgery may have a negative effect on the healing process and surgical outcome of the wound due to stress reaction and catabolism, secretion of pituitary hormone, activation of the sympathetic nervous system, and immunological changes. Therefore, proper analgesia is needed during general anesthesia. A non-invasive, non-invasive analgesic device is currently available for Surgical pleth index (SPI) to assess the status of intraoperative analgesia. SPI = 100- (0.3 * heart beat interval + 0.7 * photoplethysmographic pulse wave amplitude) is automatically and continuously calculated from the waveform of peripheral oxygen saturation.

In the postoperative pain prediction study with SPI, the SPI value at the end of the operation was found to be proportional to the pain in the recovery room. However, only the pain score immediately after the operation was confirmed in these studies. Therefore, investigators try to evaluate the degree of pain during surgery and the amount of analgesic use for management of postoperative pain.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • undergoing liver resection (laparoscopic or laparotomy)

排除标准

  • patients who refused to participate patients who have cardiac arrythmia patients who have allergic history for remifentanil

研究组 & 干预措施

SPI Group

Other

All patients who received the liver resection surgery will receive surgical pleth index

干预措施: surgical pleth index (Device)

结局指标

主要结局

The correlation of requirement of postoperative analgesics for postoperative 24 hours and intraoperative nociception score

时间窗: intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 24 hour in postoperative phase

The consumption of patient controlled analgesia and intraoperative surgical pleth index score

次要结局

  • The correlation of requirement of postoperative analgesics for postoperative 6 hours and intraoperative nociception score(intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 6 hour in postoperative phase)
  • The correlation of requirement of postoperative analgesics for postoperative 48 hours and intraoperative nociception score(intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 48 hour in postoperative phase)
  • The correlation of postoperative pain score and intraoperative nociception score(awaken after general anesthesia in post-anesthesia care unit , postoperative 6, 24, 48 hours)
  • The side effects of analgesics(awaken after general anesthesia in post-anesthesia care unit , postoperative 6, 24, 48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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