Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-27 @ 3:13 AM
Study NCT ID:
NCT01564420
Status:
COMPLETED
Last Update Posted:
2012-03-27
First Post:
2012-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Morphine Postoperative Analgesia and Pharmacokinetic/Pharmacodynamic Modeling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'For pharmacokinetic analysis, a serial of blood samples of patients was collected postoperatively after the extubation from a venous catheter (5mL each) into an EDTA tube (BD, Sao Paulo/Brazil) in the periods as follows: 0, 0.08, 0.25, 0.5, 1, 3, 6, 12, 18, 24 and 36 hrs. Blood samples were centrifuged at 2800 g for 20 minutes, plasma was transferred to labeled polyethylene vials and frozen at -80ºC until drug plasma assay.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'lastUpdateSubmitDate': '2012-03-23', 'studyFirstSubmitDate': '2012-03-22', 'studyFirstSubmitQcDate': '2012-03-23', 'lastUpdatePostDateStruct': {'date': '2012-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'two days', 'description': 'From the end of surgery until 36 hours of postoperative period'}, {'measure': 'PK/PD modelling', 'timeFrame': '2 days', 'description': 'From the begin of surgery until 36 hours of postoperative period'}], 'secondaryOutcomes': [{'measure': 'PK parameter: Cmax (peak plasma concentration)', 'timeFrame': '2 days', 'description': 'from the begin of surgery until 36 hours of postoperative period'}, {'measure': 'PK parameter: Tmax (time to achieve the maximum concentration)', 'timeFrame': '2 days', 'description': 'from the begin of surgery until 36 hours of postoperative period'}, {'measure': 'PK parameter: AUC (area under the plasma cocentration versus time curve)', 'timeFrame': '2 days', 'description': 'from the begin of surgery until 36 hours of postoperative period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pharmacokinetic/pharmacodynamic modeling', 'intrathecal morphine', 'postoperative analgesia', 'patient-controlled analgesia device'], 'conditions': ['Cardiopulmonar Artery Bypass Grafting']}, 'referencesModule': {'references': [{'pmid': '19488583', 'type': 'RESULT', 'citation': 'dos Santos LM, Santos VC, Santos SR, Malbouisson LM, Carmona MJ. Intrathecal morphine plus general anesthesia in cardiac surgery: effects on pulmonary function, postoperative analgesia, and plasma morphine concentration. Clinics (Sao Paulo). 2009;64(4):279-85. doi: 10.1590/s1807-59322009000400003.'}], 'seeAlsoLinks': [{'url': 'http://www.anestesiologiausp.com.br', 'label': 'Group web site'}, {'url': 'http://conselho.saude.gov.br/web_comissoes/conep/index.html', 'label': 'Health national council web site'}]}, 'descriptionModule': {'briefSummary': 'The currently available data are insufficient to develop a model that achieves optimum morphine dose individualization at the postoperative period of coronary artery bypass grafting (CABG). Therefore, the objective of the study was to apply a PK/PD model that could justify morphine consumption, drug plasma concentration and pain intensity during the postoperative period after CABG and evaluate the post operative pain.', 'detailedDescription': 'The protocol was a prospective, open-label study, approved by the institutional ethical committee of the hospital where the study was performed. Patients were randomly assigned to receive general anesthesia plus intrathecal morphine at a dosage of 400 mcg (morphine group) or general anesthesia alone (control group) according to a simple computer-generated list.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary artery disease, eligible to cardiopulmonary artery bypass grafting surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* eligible to cardiopulmonary artery bypass grafting surgery\n\nExclusion Criteria:\n\n* fraction of ejection below 40%\n* contraindications to neuraxial blockage\n* coagulopathy\n* use of low-weight heparin\n* warfarin or a platelet aggregation inhibitor other than aspirin,\n* systemic or local infection\n* and patients with a specific contraindication on the medication employed in the study'}, 'identificationModule': {'nctId': 'NCT01564420', 'briefTitle': 'Morphine Postoperative Analgesia and Pharmacokinetic/Pharmacodynamic Modeling', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Pharmacokinetic/Pharmacodynamic Modeling of Morphine for Postoperative Analgesia Through a Patient Controlled Device After Coronary Artery Bypass Grafting. Intrathecal Morphine Significantly Reduces Drug Consumption', 'orgStudyIdInfo': {'id': 'Santos 2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intrathecal morphine', 'description': 'Patients were randomized for general anesthesia, and allocated in the control group and morphine intrathecal group.'}, {'label': 'Control group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508-900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'School of Pharmaceutical Science', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Silvia RCJ Santos, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}, {'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair Professor', 'investigatorFullName': 'Silvia Regina Cavani Jorge Santos', 'investigatorAffiliation': 'University of Sao Paulo'}}}}