Impact of Intraoperative Non-invasive Analgesia Monitoring Using Nociception Level Index on Patient Management
NCT ID: NCT06804434
Last Updated: 2025-02-03
Study Results
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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RECRUITING
NA
160 participants
INTERVENTIONAL
2023-05-18
2026-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
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+ NOL + lidocaine group
NOL guided analgesia and intravenous lidocaine infusion
Lidocaine Intravenous Infusion
intravenous lidocaine 10 mg/ml continuous infusion
NOL
Intraoperative Nociception Level index monitoring and guided analgesia
- NOL - lidocaine group
group without NOL monitoring or lidocaine administration
No interventions assigned to this group
+ NOL - lidocaine group
NOL guided analgesia without intravenous lidocaine infusion
NOL
Intraoperative Nociception Level index monitoring and guided analgesia
- NOL + lidocaine group
group without NOL monitoring but with lidocaine intravenous infusion
Lidocaine Intravenous Infusion
intravenous lidocaine 10 mg/ml continuous infusion
Interventions
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Lidocaine Intravenous Infusion
intravenous lidocaine 10 mg/ml continuous infusion
NOL
Intraoperative Nociception Level index monitoring and guided analgesia
Eligibility Criteria
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Inclusion Criteria
* ASA score I-III
* surgery for gastric or hepatobiliary or pancreatic neoplasia
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Osoian Cristiana
OTHER
Responsible Party
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Osoian Cristiana
Principal Investigator
Locations
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Regional Gastroenterology and Hepatology Institute Octavian Fodor
Cluj-Napoca, Cluj, Romania
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NOL-1047
Identifier Type: -
Identifier Source: org_study_id
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