ANI-Guided Fentanyl Infusion During Living Donor Liver Resections

NCT06619977 | Completed

• 1 other identifier: 187
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

No Disease or Condition is Being Studied

Outcome Measures

Primary Outcomes (1)

• Postoperative Nausea and Vomiting

  from enrollment to the first 48 hours postoperatively

Study Arms (2)

Standard practice retrospective group

NO INTERVENTION

Patients undergoing living liver donor resections with general anesthesia without ANI monitoring.

ANI guided group

EXPERIMENTAL

Patients undergoing living liver donor resections with general anesthesia with ANI nociception monitoring.

Device: Analgesia nociception monitoring (ANI)

Interventions

Analgesia nociception monitoring (ANI) DEVICE

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.

ANI guided group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bogomolets National Medical University: lead

Study Sites (1)

Universal Clinic Oberig

Kyiv, Ukraine

Location

Study Officials

• Iurii Kuchyn, Professor of Anaesthesiology

  Bogomolets National Medical University, Kyiv, Ukraine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: September 27, 2022
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: February 28, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)