Viewing Study NCT06619977



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Last Modification Date: 2024-10-26 @ 3:41 PM
Study NCT ID: NCT06619977
Status: COMPLETED
Last Update Posted: None
First Post: 2024-09-23

Brief Title: ANI-Guided Fentanyl Infusion During Living Donor Liver Resections
Sponsor: None
Organization: None

Study Overview

Official Title: Analgesia Nociception Index ANI for Guiding Intraoperative Opioid Administration During Living Donor Liver Resections and Its Impact on Postoperative Nausea and Vomiting
Status: COMPLETED
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 eg mcgkg-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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None