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NCT Number: NCT06804434

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

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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Key information

Conditions

Pain Anesthesia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perioperative Care Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regional Gastroenterology and Hepatology Institute Octavian Fodor

Cluj-Napoca, Cluj, Romania

Location status: Recruiting

Location contact

Cristiana Osoian

CONTACT

[email protected]

+40743352189

Cristiana Osoian

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine Intravenous Infusion

Drug

intravenous lidocaine 10 mg/ml continuous infusion

NoL

Device

Intraoperative Nociception Level index monitoring and guided analgesia

Primary outcomes

  1. Intraoperative opioid use

    Time frame: intraoperative

    We aim to examine the effect nociception level index monitoring in major abdominal surgery on intraoperative nociception management by measuring total opioid use in NOL monitored patients vs standard care according to the anesthesiologists judgement. Moreover, crossreference interventional arms will examine the effect of intraoperative administration of lidocaine in NOL and no NOL groups on intraoperative opioid use. Intraoperative opioid use will be time adjusted ( depending on the duration of surgery) and weight adjusted (depending on the weight of the patient)- mg of opioid/hour/kg

Secondary outcomes

  1. Intraoperative pulse

    Time frame: intraoperative

    Mean pulse rate and peak pulse rate

  2. Intraoperative blood pressure

    Time frame: intraoperative

    Mean blood pressure and peak blood pressure

  3. Postoperative pain scores

    Time frame: 24 hours

    VAS score at 15 minutes, 30 minute, 2 hours 4 hours, 12 hours and 24 hours

  4. Postoperative opioid use

    Time frame: 24 hours

  5. Lidocaine related adverse events

    Time frame: 24 hours

  6. Opioid related adverse events

    Time frame: 24 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Cristiana Osoian

CONTACT

[email protected]

+40743352189

Sponsors and collaborators

Lead sponsor

Osoian Cristiana

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2025
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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