Impact of Intraoperative Non-invasive Analgesia Monitoring Using Nociception Level Index on Patient Management

Recruiting now · Not applicable

Conditions studied: Pain, Anesthesia, Perioperative Care

In brief

This prospective randomised clinical trial aims to assess the impact of intraoperative nociception monitoring using NOL on anesthetic management during major abdominal surgery. Additionally, the study will objectively evaluate using NOL how intravenous lidocaine administration, influences opioid requirements and the effect of this multimodal approach on early postoperative outcomes. The investigators hypothesize that NOL-guided intraoperative opioid administration reduces both intraoperative and postoperative opioid use, positively influencing 24-hour outcomes. Furthermore, the addition of intraoperative lidocaine in NOL-guided analgesia may further decrease opioid consumption.

Key facts

Study ID: NCT06804434
Run by: Osoian Cristiana
People needed: 160
Starts: 2023-05-18
Expected to finish: 2026-02-01
Last updated by the study team: 2025-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

age > 18 years
ASA score I-III
surgery for gastric or hepatobiliary or pancreatic neoplasia

You may not qualify if…

pregnancy
lactation
neuraxial or regional anesthesia
chronic treatment with drugs that can influence autonomic nervous system
diuretics or nitroglycerin administration on the day of surgery
severe neurological disability
severe hemodynamic instability
chronic pain
chronic opioid treatment
allergy to any of the study drugs
severe untreated disease or organ failure
pacemaker
emergency surgery
patient refusal to participate

Where it is running

Regional Gastroenterology and Hepatology Institute Octavian Fodor — Cluj-Napoca, Cluj, Romania (enrolling)

Full record on ClinicalTrials.gov

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