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

RecruitingNAAges 18 Years - anyAllOsoian Cristiana
NCT06804434 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * age \> 18 years * ASA score I-III * surgery for gastric or hepatobiliary or pancreatic neoplasia Exclusion Criteria: * 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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What it tests

  • Lidocaine Intravenous Infusion
  • NOL
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Where

1 site
Regional Gastroenterology and Hepatology Institute Octavian Fodor
Cluj-Napoca, Romania
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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