RecruitingNot ApplicableNCT06804434

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


Sponsor

Osoian Cristiana

Enrollment

160 participants

Start Date

May 18, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria14

  • 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

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Interventions

DRUGLidocaine Intravenous Infusion

intravenous lidocaine 10 mg/ml continuous infusion

DEVICENOL

Intraoperative Nociception Level index monitoring and guided analgesia


Locations(1)

Regional Gastroenterology and Hepatology Institute Octavian Fodor

Cluj-Napoca, Cluj, Romania

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NCT06804434


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