Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-02-23 @ 4:30 AM
Study NCT ID:
NCT02048293
Status:
COMPLETED
Last Update Posted:
2014-01-29
First Post:
2014-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacodynamic Differences Between Branded and Unbranded Remifentanil Molecules
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'}]}, '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-28', 'studyFirstSubmitDate': '2014-01-23', 'studyFirstSubmitQcDate': '2014-01-28', 'lastUpdatePostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite outcome of heart rate or mean arterial pressure difference before and after tracheal intubation', 'timeFrame': 'Average of 5 minutes', 'description': 'Heart rate measured with EKG. Mean arterial pressure measured with automatic blood pressure cuff.'}], 'secondaryOutcomes': [{'measure': 'Cooper intubation condition score', 'timeFrame': 'Measured during tracheal intubation, average of 30 seconds', 'description': 'Jaw relaxation: 0 poor, 1 minimum, 2 moderate, 3 good. Vocal cords: 0 closed, 1 closing, 2 moving, 3 open. Intubation response: 0 severe cough, 1 mild cough, 2 mild diaphragmatic movement, 3 no response.\n\nCooper score: Jaw relaxation + Vocal cords + Intubation response'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['remifentanil', 'propofol', 'pharmacodynamic', 'total intravenous anesthesia', 'orotracheal intubation', 'heart rate', 'mean arterial pressure', 'Cooper intubation condition score'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '22117982', 'type': 'BACKGROUND', 'citation': 'Kwak HJ, Min SK, Kim DH, Kang M, Kim JY. Effect-site concentration of remifentanil for nasotracheal versus orotracheal intubation during target-controlled infusion of propofol. J Int Med Res. 2011;39(5):1816-23. doi: 10.1177/147323001103900524.'}, {'pmid': '11573626', 'type': 'BACKGROUND', 'citation': 'Lysakowski C, Dumont L, Pellegrini M, Clergue F, Tassonyi E. Effects of fentanyl, alfentanil, remifentanil and sufentanil on loss of consciousness and bispectral index during propofol induction of anaesthesia. Br J Anaesth. 2001 Apr;86(4):523-7. doi: 10.1093/bja/86.4.523.'}, {'pmid': '20229001', 'type': 'BACKGROUND', 'citation': 'Coskun D, Celebi H, Karaca G, Karabiyik L. Remifentanil versus fentanyl compared in a target-controlled infusion of propofol anesthesia: quality of anesthesia and recovery profile. J Anesth. 2010 Jun;24(3):373-9. doi: 10.1007/s00540-010-0898-1. Epub 2010 Mar 13.'}]}, 'descriptionModule': {'briefSummary': 'Unbranded drug molecules are produced after the patent of a given drug has expired. Unbranded molecules of Remifentanil have been marketed in Colombia, and several reports by anesthesiologist indicate that there are differences in the physiologic response of patients to these molecules. The investigators hypothesized that unbranded molecules of remifentanil require higher doses to obtain desired physiological responses as compared to the branded molecule.', 'detailedDescription': 'Introduction. Several remifentanil products are commercialized in Colombia while these have never been compared in a clinical setting.\n\nObjective. The aim of this study was to investigate the pharmacodynamic profile of the innovative molecule of remifentanil (group O = Ultiva®) and two unbranded molecules (group A = Remifentanil Laboratorios Chalver de Colombia S.A. and group B = Fada Remifentanilo) registered in Colombia.\n\nMethods. The investigators carried out a double-blind, randomized, controlled trial. The branded molecule of remifentanil (group O, n=29) was compared against the two unbranded molecules (group A, n=29; group B, n=32) during anesthetic induction and tracheal intubation in adult patients American Society of Anesthesiology Physical Status Classification = I without predictors for difficult airway. The target controlled infusion (TCI) doses evaluated were 6, 8 and 10 ng/ml with the Minto model. Induction was complemented with propofol 5 mg/ml (TCI) with the Schneider model and rocuronium 0.6 mg/kg. The primary outcome was defined as the difference in mean arterial pressure and heart rate pre-intubation (TCI equilibrium) and post-intubation (maximum measurement within 5 minutes).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients requiring orotracheal intubation\n* 18-50 years old\n* Body mass index \\<31 kg/m2\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Risk of difficult airway\n* History of opioid use'}, 'identificationModule': {'nctId': 'NCT02048293', 'briefTitle': 'Pharmacodynamic Differences Between Branded and Unbranded Remifentanil Molecules', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Universitaria de Ciencias de la Salud'}, 'officialTitle': 'Pharmacodynamic Differences Between Branded and Unbranded Remifentanil Molecules Available in Colombia for Tracheal Intubation of Adult Patients, 2012-2013', 'orgStudyIdInfo': {'id': '326-3847-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group O', 'description': 'Remifentanyl innovative molecule = Ultiva®', 'interventionNames': ['Drug: Remifentanyl, Ultiva®', 'Drug: Fada Remifentanilo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Remifentanyl comparator A = Remifentanil Laboratorios Chalver de Colombia S.A.', 'interventionNames': ['Drug: Remifentanil Laboratorios Chalver de Colombia S.A.', 'Drug: Fada Remifentanilo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Remifentanyl comparator B = Fada Remifentanilo', 'interventionNames': ['Drug: Remifentanyl, Ultiva®', 'Drug: Remifentanil Laboratorios Chalver de Colombia S.A.']}], 'interventions': [{'name': 'Remifentanyl, Ultiva®', 'type': 'DRUG', 'description': 'Anesthetic induction for orotracheal intubation. Group O', 'armGroupLabels': ['Group B', 'Group O']}, {'name': 'Remifentanil Laboratorios Chalver de Colombia S.A.', 'type': 'DRUG', 'description': 'Anesthetic induction for orotracheal intubation. Group A', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'Fada Remifentanilo', 'type': 'DRUG', 'description': 'Anesthetic induction for orotracheal intubation. Group B', 'armGroupLabels': ['Group A', 'Group O']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11001000', 'city': 'Bogota', 'state': 'Cundinamarca', 'country': 'Colombia', 'facility': 'Fundación Universitaria de Ciencias de la Salud, Hospital de San Jose'}], 'overallOfficials': [{'name': 'luis e reyes, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'fundacion universitaria de ciencias de la salud'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Universitaria de Ciencias de la Salud', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital de San Jose', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician, Anesthesiologist, Intensive Care Specialist, Professor Fundación Universitaria de Ciencias de la Salud, Hospital de San José, Bogotá D.C.', 'investigatorFullName': 'Luis Eduardo Reyes Ortiz, MD', 'investigatorAffiliation': 'Fundación Universitaria de Ciencias de la Salud'}}}}