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

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.

Study Overview

• Status: Completed
• Conditions: No Disease or Condition is Being Studied
• Intervention / Treatment: Device: Analgesia nociception monitoring (ANI)

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Kyiv, Ukraine
    • Universal Clinic Oberig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard practice retrospective group; Patients undergoing living liver donor resections with general anesthesia without ANI monitoring.
Experimental: ANI guided group; Patients undergoing living liver donor resections with general anesthesia with ANI nociception monitoring.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative Nausea and Vomiting	from enrollment to the first 48 hours postoperatively

Collaborators and Investigators

• Sponsor: Bogomolets National Medical University
• Investigators: Study Director: Iurii Kuchyn, Professor of Anaesthesiology, Bogomolets National Medical University, Kyiv, Ukraine

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2022
• Primary Completion (Actual): May 9, 2023
• Study Completion (Actual): May 9, 2023

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 29, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the institutional policy, the IPD will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No