Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
Study NCT ID:
NCT04138966
Status:
UNKNOWN
Last Update Posted:
2020-11-09
First Post:
2019-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Skin Conductance and Nol-index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005712', 'term': 'Galvanic Skin Response'}], 'ancestors': [{'id': 'D011580', 'term': 'Psychological Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D055724', 'term': 'Electrophysiological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D012879', 'term': 'Skin Physiological Phenomena'}, {'id': 'D055827', 'term': 'Integumentary System Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-06', 'studyFirstSubmitDate': '2019-10-23', 'studyFirstSubmitQcDate': '2019-10-23', 'lastUpdatePostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nol-Index response', 'timeFrame': '1 to 2 hours', 'description': 'Nol-Index (diminsenliss value from 0 to 100) will be assessed during noxious and non noxious stimuli'}, {'measure': 'Skin conductance response', 'timeFrame': '1 to 2 hours', 'description': 'Peaks per second change during noxious and non noxious stimuli'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia', 'Anesthesia', 'Monitoring', 'Vascular Diseases', 'Cardiac Disease']}, 'descriptionModule': {'briefSummary': 'Comparison of twà different nociception monitors during general anesthesia', 'detailedDescription': 'Analgesia remains a challenge in anesthesia. Several monitors have shown potential in detecting insufficient analgesia during general anesthesia, but they have not been investigated in patients undergoing cardiac and vascular surgery. In this study, we will compare skin conductance (Medstorm, Norway) and nol-index (Medasense, Israel) w during noxious and non-noxious stimuli. This study is carried out on patients included in another study (Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing cardiac or vascular surgery', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* moderate-to-high risk cardiac or vascular surgery\n* ASA 2-4\n\nExclusion Criteria:\n\n* chronic arrhythmia (e.g. atrial fibrillation)\n* aortic insufficiency\n* pacemaker\n* implanted defibrillator\n* valve surgery'}, 'identificationModule': {'nctId': 'NCT04138966', 'briefTitle': 'Comparing Skin Conductance and Nol-index', 'organization': {'class': 'OTHER', 'fullName': 'Erasme University Hospital'}, 'officialTitle': 'Nociceptive Monitoring With Skin Conductance and Nol-index in Moderate-to-high Risk Cardiovascular Patients', 'orgStudyIdInfo': {'id': 'P2019/427Am1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing general anesthesia', 'description': 'Patients are monitored with Nol-Index, skin conductance, and antinociception-index', 'interventionNames': ['Device: Nol-Index', 'Device: Skin Conductance']}], 'interventions': [{'name': 'Nol-Index', 'type': 'DEVICE', 'otherNames': ['PMD-200'], 'description': 'Multiparametric monitor that studies that establishes an index as a surrogate to nociception', 'armGroupLabels': ['Patients undergoing general anesthesia']}, {'name': 'Skin Conductance', 'type': 'DEVICE', 'otherNames': ['The PainMonitor Index'], 'description': 'Measures skin conductance as a surrogate to nociception', 'armGroupLabels': ['Patients undergoing general anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Sean Coeckelenbergh, MD', 'role': 'CONTACT'}], 'facility': 'Anesthesia Department, Erasme Hospital', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Sean Coeckelenbergh, MD', 'role': 'CONTACT', 'email': 'secoecke@ulb.ac.be', 'phone': '32 (0) 2 555 39 19'}, {'name': 'Luc Barvais, MD, PhD', 'role': 'CONTACT', 'phone': '32 (0) 2 555 39 19'}], 'overallOfficials': [{'name': 'Luc Barvais, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesia Department, Erasme Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasme University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}