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

NCT ID: NCT06804434

Last Updated: 2025-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-18

Study Completion Date

2026-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Anesthesia Perioperative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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+ NOL + lidocaine group

NOL guided analgesia and intravenous lidocaine infusion

Group Type EXPERIMENTAL

Lidocaine Intravenous Infusion

Intervention Type DRUG

intravenous lidocaine 10 mg/ml continuous infusion

NOL

Intervention Type DEVICE

Intraoperative Nociception Level index monitoring and guided analgesia

- NOL - lidocaine group

group without NOL monitoring or lidocaine administration

Group Type NO_INTERVENTION

No interventions assigned to this group

+ NOL - lidocaine group

NOL guided analgesia without intravenous lidocaine infusion

Group Type EXPERIMENTAL

NOL

Intervention Type DEVICE

Intraoperative Nociception Level index monitoring and guided analgesia

- NOL + lidocaine group

group without NOL monitoring but with lidocaine intravenous infusion

Group Type EXPERIMENTAL

Lidocaine Intravenous Infusion

Intervention Type DRUG

intravenous lidocaine 10 mg/ml continuous infusion

Interventions

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Lidocaine Intravenous Infusion

intravenous lidocaine 10 mg/ml continuous infusion

Intervention Type DRUG

NOL

Intraoperative Nociception Level index monitoring and guided analgesia

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Osoian Cristiana

OTHER

Sponsor Role lead

Responsible Party

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Osoian Cristiana

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Regional Gastroenterology and Hepatology Institute Octavian Fodor

Cluj-Napoca, Cluj, Romania

Site Status RECRUITING

Countries

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Romania

Central Contacts

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Cristiana Osoian

Role: CONTACT

+40743352189

Facility Contacts

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Cristiana Osoian

Role: primary

+40743352189

Other Identifiers

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NOL-1047

Identifier Type: -

Identifier Source: org_study_id

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