Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-03-02 @ 6:24 PM
Study NCT ID:
NCT06804434
Status:
RECRUITING
Last Update Posted:
2025-02-03
First Post:
2025-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Intraoperative Non-invasive Analgesia Monitoring Using Nociception Level Index on Patient Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2025-01-19', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative opioid use', 'timeFrame': 'intraoperative', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Intraoperative pulse', 'timeFrame': 'intraoperative', 'description': 'Mean pulse rate and peak pulse rate'}, {'measure': 'Intraoperative blood pressure', 'timeFrame': 'intraoperative', 'description': 'Mean blood pressure and peak blood pressure'}, {'measure': 'Postoperative pain scores', 'timeFrame': '24 hours', 'description': 'VAS score at 15 minutes, 30 minute, 2 hours 4 hours, 12 hours and 24 hours'}, {'measure': 'Postoperative opioid use', 'timeFrame': '24 hours'}, {'measure': 'Lidocaine related adverse events', 'timeFrame': '24 hours'}, {'measure': 'Opioid related adverse events', 'timeFrame': '24 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Anesthesia', 'Perioperative Care']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years\n* ASA score I-III\n* surgery for gastric or hepatobiliary or pancreatic neoplasia\n\nExclusion Criteria:\n\n* pregnancy\n* lactation\n* neuraxial or regional anesthesia\n* chronic treatment with drugs that can influence autonomic nervous system\n* diuretics or nitroglycerin administration on the day of surgery\n* severe neurological disability\n* severe hemodynamic instability\n* chronic pain\n* chronic opioid treatment\n* allergy to any of the study drugs\n* severe untreated disease or organ failure\n* pacemaker\n* emergency surgery\n* patient refusal to participate'}, 'identificationModule': {'nctId': 'NCT06804434', 'briefTitle': 'Impact of Intraoperative Non-invasive Analgesia Monitoring Using Nociception Level Index on Patient Management', 'organization': {'class': 'OTHER', 'fullName': 'Iuliu Hatieganu University of Medicine and Pharmacy'}, 'officialTitle': 'Impact of Intraoperative Non-invasive Analgesia Monitoring Using Nociception Level Index on Patient Management', 'orgStudyIdInfo': {'id': 'NOL-1047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '+ NOL + lidocaine group', 'description': 'NOL guided analgesia and intravenous lidocaine infusion', 'interventionNames': ['Drug: Lidocaine Intravenous Infusion', 'Device: NOL']}, {'type': 'NO_INTERVENTION', 'label': '- NOL - lidocaine group', 'description': 'group without NOL monitoring or lidocaine administration'}, {'type': 'EXPERIMENTAL', 'label': '+ NOL - lidocaine group', 'description': 'NOL guided analgesia without intravenous lidocaine infusion', 'interventionNames': ['Device: NOL']}, {'type': 'EXPERIMENTAL', 'label': '- NOL + lidocaine group', 'description': 'group without NOL monitoring but with lidocaine intravenous infusion', 'interventionNames': ['Drug: Lidocaine Intravenous Infusion']}], 'interventions': [{'name': 'Lidocaine Intravenous Infusion', 'type': 'DRUG', 'description': 'intravenous lidocaine 10 mg/ml continuous infusion', 'armGroupLabels': ['+ NOL + lidocaine group', '- NOL + lidocaine group']}, {'name': 'NOL', 'type': 'DEVICE', 'description': 'Intraoperative Nociception Level index monitoring and guided analgesia', 'armGroupLabels': ['+ NOL + lidocaine group', '+ NOL - lidocaine group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cluj-Napoca', 'state': 'Cluj', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Cristiana Osoian', 'role': 'CONTACT', 'email': 'osoiancris@yahoo.com', 'phone': '+40743352189'}, {'name': 'Cristiana Osoian', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Regional Gastroenterology and Hepatology Institute Octavian Fodor', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}], 'centralContacts': [{'name': 'Cristiana Osoian', 'role': 'CONTACT', 'email': 'osoiancris@yahoo.com', 'phone': '+40743352189'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osoian Cristiana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Osoian Cristiana', 'investigatorAffiliation': 'Iuliu Hatieganu University of Medicine and Pharmacy'}}}}