Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT02588118
Status:
COMPLETED
Last Update Posted:
2019-08-12
First Post:
2015-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gender and PK-PD of Propofol and Cisatracurium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'C101584', 'term': 'cisatracurium'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-09', 'studyFirstSubmitDate': '2015-10-23', 'studyFirstSubmitQcDate': '2015-10-24', 'lastUpdatePostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'propofol elimination half life', 'timeFrame': 'before administration till 120 minutes', 'description': 'Propofol 3 mg/kg (t0) followed by cisatracurium 0.1 mg/kg 2 min (t2). Patients will be monitored using bispectral index monitoring for propofol. Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration. Blood samples were assayed in duplicate using high performance liquid chromatograph for Pharmacokinetic analysis.'}], 'secondaryOutcomes': [{'measure': 'cisatracurium elimination half life', 'timeFrame': 'before administration till 120 minutes', 'description': 'Propofol 3 mg/kg (t0) followed by cisatracurium 0.1 mg/kg 2 min (t2). Patients will be monitored using TOF-Watch neuromuscular monitoring for cisatracurium. Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration. Blood samples were assayed in duplicate using high performance liquid chromatograph for Pharmacokinetic analysis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gender']}, 'referencesModule': {'references': [{'pmid': '9034227', 'type': 'BACKGROUND', 'citation': 'Schmith VD, Fiedler-Kelly J, Phillips L, Grasela TH Jr. Prospective use of population pharmacokinetics/pharmacodynamics in the development of cisatracurium. Pharm Res. 1997 Jan;14(1):91-7. doi: 10.1023/a:1012015719694.'}, {'pmid': '11573657', 'type': 'BACKGROUND', 'citation': 'Vuyk J, Oostwouder CJ, Vletter AA, Burm AG, Bovill JG. Gender differences in the pharmacokinetics of propofol in elderly patients during and after continuous infusion. Br J Anaesth. 2001 Feb;86(2):183-8. doi: 10.1093/bja/86.2.183.'}]}, 'descriptionModule': {'briefSummary': 'In recent years it has become clear that gender differences exist both in the pharmacokinetics and the pharmacodynamics of drugs related to the practice of anesthesia. Differences in pharmacokinetics are more straightforward to study than differences in clinical effects. However, isolated pharmacokinetic data are of less value if they are not accompanied by measurements of clinical effects. Males are more sensitive than females to propofol. It may therefore be necessary to decrease the propofol dose by 30-40% in males. Females have 20-30% greater sensitivity to the muscle relaxant effects.', 'detailedDescription': 'Background: In recent years it has become clear that gender differences exist both in the pharmacokinetics and the pharmacodynamics of drugs related to the practice of anesthesia. Differences in pharmacokinetics are more straightforward to study than differences in clinical effects. However, isolated pharmacokinetic data are of less value if they are not accompanied by measurements of clinical effects. Males are more sensitive than females to propofol. It may therefore be necessary to decrease the propofol dose by 30-40% in males. Females have 20-30% greater sensitivity to the muscle relaxant effects.\n\nMethods: Anaesthesia is induced with propofol 2 mg/kg (t0) followed by cisatracurium 0.1 mg/kg 1 min from propofol administration (t2). Patients will be monitored using the conventionally available bispectral index monitoring for propofol concentrations and Relaxometer mechanomyograph neuromuscular monitoring for cisatracurium. Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration. Blood samples were assayed in duplicate using high performance liquid chromatograph. Pharmacokinetic analysis was performed by fitting the cisatracurium blood concentration time profile of individual patients, to non-compartmental as well as multi-compartmental pharmacokinetic models.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'differences between equal numbers of males and females', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. either males or females\n\nExclusion Criteria:\n\n1\\. Liver disease'}, 'identificationModule': {'nctId': 'NCT02588118', 'acronym': 'BIS5', 'briefTitle': 'Gender and PK-PD of Propofol and Cisatracurium', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Effect of Gender on the Pharmacokinetics-pharmacodynamics of Propofol and Cisatracurium Besylate', 'orgStudyIdInfo': {'id': 'MUGraz5'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'male group', 'description': 'Propofol 2 mg/kg (t0) followed by cisatracurium 0.1 mg/kg 1 min (t2). Patients will be monitored using bispectral index monitoring for propofol and Relaxometer mechanomyograph neuromuscular monitoring for cisatracurium. Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration. Blood samples were assayed in duplicate using high performance liquid chromatograph for Pharmacokinetic analysis.', 'interventionNames': ['Drug: propofol', 'Drug: Cisatracurium']}, {'label': 'female group', 'description': 'Propofol 2 mg/kg (t0) followed by cisatracurium 0.1 mg/kg 1 min (t2). Patients will be monitored using bispectral index monitoring for propofol and Relaxometer mechanomyograph neuromuscular monitoring for cisatracurium. Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration. Blood samples were assayed in duplicate using high performance liquid chromatograph for Pharmacokinetic analysis.', 'interventionNames': ['Drug: propofol', 'Drug: Cisatracurium']}], 'interventions': [{'name': 'propofol', 'type': 'DRUG', 'otherNames': ['diprivan'], 'description': 'Propofol 2 mg/kg (t0) followed by cisatracurium 0.1 mg/kg 1 min (t2). Patients will be monitored using bispectral index monitoring for propofol and Relaxometer mechanomyograph neuromuscular monitoring for cisatracurium. Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration. Blood samples were assayed in duplicate using high performance liquid chromatograph for Pharmacokinetic analysis.', 'armGroupLabels': ['female group', 'male group']}, {'name': 'Cisatracurium', 'type': 'DRUG', 'otherNames': ['nimbix'], 'description': 'Propofol 2 mg/kg (t0) followed by cisatracurium 0.1 mg/kg 1 min (t2). Patients will be monitored using bispectral index monitoring for propofol and Relaxometer mechanomyograph neuromuscular monitoring for cisatracurium. Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration. Blood samples were assayed in duplicate using high performance liquid chromatograph for Pharmacokinetic analysis.', 'armGroupLabels': ['female group', 'male group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8046', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing hospital of Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Ashraf Dahaba', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Ashraf Dahaba, MD', 'investigatorAffiliation': 'Medical University of Graz'}}}}