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

NCT06804434 | Recruiting

• 1 other identifier: NOL-1047
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Anesthesia; Perioperative Care

Outcome Measures

Primary Outcomes (1)

• Intraoperative opioid use

  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

  intraoperative

Secondary Outcomes (6)

• Intraoperative pulse

  intraoperative

• Intraoperative blood pressure

  intraoperative

• Postoperative pain scores

  24 hours

• Postoperative opioid use

  24 hours

• Lidocaine related adverse events

  24 hours

Study Arms (4)

+ NOL + lidocaine group

EXPERIMENTAL

NOL guided analgesia and intravenous lidocaine infusion

Drug: Lidocaine Intravenous Infusion; Device: NOL

- NOL - lidocaine group

NO INTERVENTION

group without NOL monitoring or lidocaine administration

+ NOL - lidocaine group

EXPERIMENTAL

NOL guided analgesia without intravenous lidocaine infusion

Device: NOL

- NOL + lidocaine group

EXPERIMENTAL

group without NOL monitoring but with lidocaine intravenous infusion

Drug: Lidocaine Intravenous Infusion

Interventions

Lidocaine Intravenous Infusion DRUG

intravenous lidocaine 10 mg/ml continuous infusion

+ NOL + lidocaine group; - NOL + lidocaine group

NOL DEVICE

Intraoperative Nociception Level index monitoring and guided analgesia

+ NOL + lidocaine group; + NOL - lidocaine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Osoian Cristiana: lead

Study Sites (1)

Regional Gastroenterology and Hepatology Institute Octavian Fodor

Cluj-Napoca, Cluj, Romania

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cristiana Osoian

CONTACT

+40743352189; osoiancris@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: February 3, 2025
• Study Start: May 18, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

RO (1)