NCT06619977

ANI-Guided Fentanyl Infusion During Living Donor Liver Resections

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Bogomolets National Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• No Disease or Condition is Being Studied

Interventions

Type	Name	Description
DEVICE	Analgesia nociception monitoring (ANI)	Analgesia nociception index (ANI; MetroDoloris Medical Systems, Lille, France) is a noninvasive tool for monitoring the intraoperative state of the autonomic nervous system, in particular - the parasympathetic nervous system. The ANI algorithm uses data from one lead ECG trace. Heart rate variability, or the beat-to-beat alterations in heart rate, is a well-known and recognised noninvasive indicator of autonomic nervous system activity.

Timeline

• Start date: 2022-09-27
• Primary completion: 2023-05-09
• Completion: 2023-05-09
• First posted: 2024-10-01
• Last updated: 2025-02-28

Locations

1 site across 1 country: Ukraine