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临床试验/NCT03761433
NCT03761433已完成不适用

the Prediction of Postoperative Pain With Surgical Incision Stimulation in the Patients Undergoing Gastrectomy

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
intraoperative nociception score (surgical pleth index)

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 relation intraoperative nociception response with postoperative pain score.

In similar anesthetic depth(End tidal sevoflurane 3%) , changes of surgical pleth index values for stimulus of skin incision are thought to reflect the individual nociception characteristics.

详细描述

Patients who undergoing upper abdominal laparotomy surgery usually experience severe postoperative pain. Previous studies were reported that preoperative pain, young age, high-dose remifentanil, and depression were associated with severe postoperative pain.

However, anesthesia-related studies were either retrospective studies or injected with anesthetic agents in excess of clinical doses to differentiate between groups. There is no objective indicator for prediction severe postoperative pain.The purpose of this study was to investigate the relationship between intraoperative pain response and postoperative pain on standardized surveillance devices.

To maintain the depth of anesthesia, an EEG monitoring device bispectral index (BIS) is used. Also, surgical pleth index (SPI, GE healthcare, Freiburg, Germany) is a noninvasive pain-analgesia balance monitoring device that is commercially available to evaluate the state of pain during general anesthesia. 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 similar anesthetic depth(End tidal sevoflurane 3%) , changes of SPI values for stimulus of skin incision are thought to reflect the individual nociception characteristics. The investigators hypothesized the higher analgesics consumption can predict with high SPI response following incisional stimuli.

Thus, investigators try to evaluate the comparison of two groups ( high fentanyl consumption group vs. low fentanyl consumption group) with intraoperative SPI value (incision and before aurosal) and hemodynamic parameters under End tidal sevoflurane 3%(anesthesia depth, hemodynamically stable and appropriate anesthetic depth based on previous studies were confirmed at the time of skin incision). And the characteristics and emotional status of patients in two groups are compared.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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 laparotomy gastrectomy

排除标准

  • cardiac arrythmia
  • allergic history for drugs
  • renal failure (Cr> 1.5 mg/dl)

结局指标

主要结局

intraoperative nociception score (surgical pleth index)

时间窗: intraoperative at the time of skin incision

under End tidal sevoflurane 3%, surgical pleth index score following surgical incision

The requirement of postoperative analgesics for postoperative 24 hours

时间窗: postoperative 24 hour

The requirement of postoperative analgesics for postoperative 24 hours (opioid conversion to fentanyl dose mcg)

The immediate postoperative pain score

时间窗: postoperative 24 hour

The numeric rating pain score, no pain=0 \~ worst pain=10

次要结局

  • The correlation of highest postoperative pain score and intraoperative nociception score(postoperative 1 hour)
  • The correlation of requirement of summed postoperative analgesics and intraoperative nociception score(postoperative 1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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