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Recruiting NCT06804434

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

No phase Interventional Pain Anesthesia Perioperative Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lidocaine Intravenous Infusion, NOL.
Who it may be relevant to
Registry conditions: Pain, Anesthesia, Perioperative Care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Romania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Lidocaine Intravenous Infusion
    intravenous lidocaine 10 mg/ml continuous infusion
  • Device NOL
    Intraoperative Nociception Level index monitoring and guided analgesia

Primary outcome measures

  • Intraoperative opioid use [Time frame: intraoperative]
Secondary outcome measures (6)
  • Intraoperative pulse [Time frame: intraoperative]
  • Intraoperative blood pressure [Time frame: intraoperative]
  • Postoperative pain scores [Time frame: 24 hours]
  • Postoperative opioid use [Time frame: 24 hours]
  • Lidocaine related adverse events [Time frame: 24 hours]
  • Opioid related adverse events [Time frame: 24 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Single blind
Primary purpose
Supportive care

Study locations

Romania · 1 center
  • Regional Gastroenterology and Hepatology Institute Octavian Fodor — Cluj-Napoca

Identifiers

NCT: NCT06804434 · NOL-1047

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗