Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-22 @ 9:36 AM
Study NCT ID:
NCT02566733
Status:
COMPLETED
Last Update Posted:
2016-10-19
First Post:
2015-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minto Model in Effect Site Mode for Target-Controlled Infusion of Remifentanil During Cardiopulmonary Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-18', 'studyFirstSubmitDate': '2015-09-29', 'studyFirstSubmitQcDate': '2015-10-01', 'lastUpdatePostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median prediction error', 'timeFrame': 'during CPB'}], 'secondaryOutcomes': [{'measure': 'changes of measured total remifentanil concentration', 'timeFrame': '1 hour after anesthesia induction, 30/60/90 min after the beginning of cardiopulmonary bypass, 1 hour after the end of cardiopulmonary bypass'}, {'measure': 'Median absolute prediction error', 'timeFrame': 'during CPB'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['remifentanil'], 'conditions': ['Anesthetics, Intravenous', 'Pharmacology', 'Anesthetics', 'Cardiopulmonary Bypass']}, 'descriptionModule': {'briefSummary': 'Target controlled infusion with remifentanil is widely used during cardiac surgery, wich is performed using the Minto model. It was derived from patients undergoing general surgery. However, pharmacokinetics of remifentanil can be changed during cardiopulmonary bypass. The investigators tested whether Minto model for target controlled infusion produces constant plasma remifentanil concentration during the cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with the ASA class I\\~III undergoing elective cardiac surgery using cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Patients not using target controlled infusion during the operation\n* Patients with drug/substance abuse\n* Patients using analgesics before this study starts\n* Pregnant women\n* Patients who rejected study participation'}, 'identificationModule': {'nctId': 'NCT02566733', 'briefTitle': 'Minto Model in Effect Site Mode for Target-Controlled Infusion of Remifentanil During Cardiopulmonary Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Performance of the Minto Model in Effect Site Mode for Target Controlled Infusion of Remifentanil During Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': 'Remifentanil_CPB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remiva', 'description': 'This experimental group will use a generic drug of remifentanil, Remiva™ from Hana Pharmaceutical company.', 'interventionNames': ['Drug: Remiva']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ultiva', 'description': 'This arm group will use a brand-named drug of remifentanil, Ultiva™ from GlaxoSmithKline company.', 'interventionNames': ['Drug: Ultiva']}], 'interventions': [{'name': 'Remiva', 'type': 'DRUG', 'otherNames': ['generic drug of remifentanil, Remiva™'], 'description': 'Target controlled infusion of remifentanil (generic drug, Remiva™)', 'armGroupLabels': ['Remiva']}, {'name': 'Ultiva', 'type': 'DRUG', 'otherNames': ['brand-named drug of remifentanil, Ultiva™'], 'description': 'Target controlled infusion of remifentanil (brand-named drug, Ultiva™)', 'armGroupLabels': ['Ultiva']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Tae Kyong Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Tae Kyong Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}