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临床试验/NCT06619977
NCT06619977已完成不适用

Analgesia Nociception Index (ANI) for Guiding Intraoperative Opioid Administration During Living Donor Liver Resection and Its Impact on Postoperative Nausea and Vomiting

Bogomolets National Medical University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年9月27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
Postoperative Nausea and Vomiting

研究概览

简要总结

Thу goal of this study was to learn whether intraoperative analgesia nociception monitoring (ANI) could be beneficial during intraoperative monitoring for patients undergoing living donor liver resections. The main questions it aims to answer are:

  • Could it impact the average dose of intraoperative fentanyl used?
  • Could it impact the occurrence of postoperative nausea and vomiting?

Patients who were included in this study underwent living liver donor resections with fentanyl infusion and thoracic epidural analgesia. Two groups of patients were analysed - the ANI group (n = 24), in which fentanyl dose was adjusted with ANI monitoring, and the retrospective control group (n = 25) with a standard practice without ANI monitoring.

详细描述

Monitoring nociception accurately during general anaesthesia has presented a long-standing difficulty. Typically, anaesthesiologists rely on changes in the autonomic nervous system, such as heart rate, blood pressure, and sweating, to help determine the need for pain relief medication. Analgesia nociception index (ANI) is a noninvasive tool for monitoring the intraoperative state of the autonomic nervous system, particularly the parasympathetic nervous system.

During the long-lasting high nociceptive surgery, the infusion of fentanyl was used at our institution. Opioids can lead to postoperative nausea, vomiting, and other complications when an overdose occurs. Fentanyl dosage changes significantly after hours of infusion due to context-sensitive halftime. It is practically impossible to adjust an infusion dose with the subjective evaluation of standard monitoring, such as heart rate and blood pressure. Doses of opioids that we use in our daily practice, e.g. mcg.kg-1, are unpredictable and vary between individuals due to pharmacogenetics and pharmacokinetic reasons. The best method to exclude pharmacokinetic peculiarities and predict the subsequent dose is to directly measure analgesic agents' concentration in the blood, though it is practically impossible. This study aimed to assess whether intraoperative analgesia nociception monitoring (ANI) could have an impact on the average intraoperative dose of fentanyl and on the occurrence of postoperative nausea and vomiting.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Female and male patients, 18 - 60 years old, undergoing living donor liver resections with general anaesthesia with sevoflurane, thoracic epidural analgesia and fentanyl on infusion. ASA I, II

排除标准

  • patients with cardiac arrhythmia (atrial fibrillation, frequent extrasystoles - more than one extrasystole in 30 seconds), total intravenous anaesthesia with propofol

结局指标

主要结局

Postoperative Nausea and Vomiting

时间窗: from enrollment to the first 48 hours postoperatively

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nazarii Mysynchuk

MD

Bogomolets National Medical University

研究点 (1)

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