Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT02376595
Status:
COMPLETED
Last Update Posted:
2015-03-03
First Post:
2015-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic and Pharmacodynamic of Rocuronium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-25', 'studyFirstSubmitDate': '2015-02-12', 'studyFirstSubmitQcDate': '2015-02-25', 'lastUpdatePostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'strength measuring 2 acceleromyograph. One Placed at the masseter muscle and the other one at the adductor pollicis muscle.', 'timeFrame': '60 minutes'}, {'measure': 'Measure blood concentrations after administration rocuronium', 'timeFrame': '120 minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rocuronium', 'Pharmacokinetics', 'Pharmacodynamics'], 'conditions': ['Neuromuscular Blockade']}, 'referencesModule': {'references': [{'pmid': '7648768', 'type': 'BACKGROUND', 'citation': 'Plaud B, Proost JH, Wierda JM, Barre J, Debaene B, Meistelman C. Pharmacokinetics and pharmacodynamics of rocuronium at the vocal cords and the adductor pollicis in humans. Clin Pharmacol Ther. 1995 Aug;58(2):185-91. doi: 10.1016/0009-9236(95)90196-5.'}, {'pmid': '1673592', 'type': 'BACKGROUND', 'citation': 'Donati F, Meistelman C, Plaud B. Vecuronium neuromuscular blockade at the adductor muscles of the larynx and adductor pollicis. Anesthesiology. 1991 May;74(5):833-7. doi: 10.1097/00000542-199105000-00006.'}, {'pmid': '20650376', 'type': 'BACKGROUND', 'citation': 'Saitoh Y, Oshima T, Nakata Y. Acceleromyographic monitoring of neuromuscular block over the orbicularis oris muscle in anesthetized patients receiving vecuronium. J Clin Anesth. 2010 Aug;22(5):318-23. doi: 10.1016/j.jclinane.2009.09.004.'}, {'pmid': '21484503', 'type': 'BACKGROUND', 'citation': 'Kitajima O, Suzuki T, Fukano N, Saeki S, Ogawa S, Noda Y. Onset of rocuronium-induced neuromuscular block evaluated subjectively and accerelomyographically at the masseter muscle. J Anesth. 2011 Jun;25(3):376-9. doi: 10.1007/s00540-011-1129-0. Epub 2011 Apr 12.'}, {'pmid': '8092503', 'type': 'BACKGROUND', 'citation': "Cantineau JP, Porte F, d'Honneur G, Duvaldestin P. Neuromuscular effects of rocuronium on the diaphragm and adductor pollicis muscles in anesthetized patients. Anesthesiology. 1994 Sep;81(3):585-90. doi: 10.1097/00000542-199409000-00010."}, {'pmid': '10618945', 'type': 'BACKGROUND', 'citation': 'Ibebunjo C, Srikant CB, Donati F. Morphological correlates of the differential responses of muscles to vecuronium. Br J Anaesth. 1999 Aug;83(2):284-91. doi: 10.1093/bja/83.2.284.'}, {'pmid': '2751140', 'type': 'BACKGROUND', 'citation': 'Smith CE, Donati F, Bevan DR. Differential effects of pancuronium on masseter and adductor pollicis muscles in humans. Anesthesiology. 1989 Jul;71(1):57-61. doi: 10.1097/00000542-198907000-00011.'}, {'pmid': '15000421', 'type': 'BACKGROUND', 'citation': 'Zhang L, Beal SL, Sheiner LB. Simultaneous vs. sequential analysis for population PK/PD data I: best-case performance. J Pharmacokinet Pharmacodyn. 2003 Dec;30(6):387-404. doi: 10.1023/b:jopa.0000012998.04442.1f.'}, {'pmid': '9605675', 'type': 'BACKGROUND', 'citation': 'Schnider TW, Minto CF, Gambus PL, Andresen C, Goodale DB, Shafer SL, Youngs EJ. The influence of method of administration and covariates on the pharmacokinetics of propofol in adult volunteers. Anesthesiology. 1998 May;88(5):1170-82. doi: 10.1097/00000542-199805000-00006.'}, {'pmid': '17635389', 'type': 'BACKGROUND', 'citation': 'Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.'}, {'pmid': '11065197', 'type': 'BACKGROUND', 'citation': 'Viby-Mogensen J, Ostergaard D, Donati F, Fisher D, Hunter J, Kampmann JP, Kopman A, Proost JH, Rasmussen SN, Skovgaard LT, Varin F, Wright PM. Pharmacokinetic studies of neuromuscular blocking agents: good clinical research practice (GCRP). Acta Anaesthesiol Scand. 2000 Nov;44(10):1169-90. doi: 10.1034/j.1399-6576.2000.441002.x.'}, {'pmid': '23377654', 'type': 'BACKGROUND', 'citation': 'Cho HE, Park MJ, Kim SC, Hong RS, Moon DC, Ahn SY. Analysis of rocuronium in human whole blood and tissues using liquid chromatography-tandem mass spectrometry. J Chromatogr Sci. 2013 Apr;51(4):297-301. doi: 10.1093/chromsci/bms252. Epub 2013 Feb 1.'}, {'pmid': '15000422', 'type': 'BACKGROUND', 'citation': 'Zhang L, Beal SL, Sheinerz LB. Simultaneous vs. sequential analysis for population PK/PD data II: robustness of methods. J Pharmacokinet Pharmacodyn. 2003 Dec;30(6):405-16. doi: 10.1023/b:jopa.0000012999.36063.4e.'}, {'pmid': '761446', 'type': 'BACKGROUND', 'citation': 'Sheiner LB, Stanski DR, Vozeh S, Miller RD, Ham J. Simultaneous modeling of pharmacokinetics and pharmacodynamics: application to d-tubocurarine. Clin Pharmacol Ther. 1979 Mar;25(3):358-71. doi: 10.1002/cpt1979253358.'}, {'pmid': '11927473', 'type': 'BACKGROUND', 'citation': 'Dragne A, Varin F, Plaud B, Donati F. Rocuronium pharmacokinetic-pharmacodynamic relationship under stable propofol or isoflurane anesthesia. Can J Anaesth. 2002 Apr;49(4):353-60. doi: 10.1007/BF03017322.'}, {'pmid': '11135721', 'type': 'BACKGROUND', 'citation': 'Kuipers JA, Boer F, Olofsen E, Bovill JG, Burm AG. Recirculatory pharmacokinetics and pharmacodynamics of rocuronium in patients: the influence of cardiac output. Anesthesiology. 2001 Jan;94(1):47-55. doi: 10.1097/00000542-200101000-00012.'}, {'pmid': '10434167', 'type': 'BACKGROUND', 'citation': 'De Mey JC, De Baerdemaeker L, De Laat M, Rolly G. The onset of neuromuscular block at the masseter muscle as a predictor of optimal intubating conditions with rocuronium. Eur J Anaesthesiol. 1999 Jun;16(6):387-9. doi: 10.1046/j.1365-2346.1999.00503.x.'}, {'pmid': '16011632', 'type': 'BACKGROUND', 'citation': 'Nakamura Y, Torisu T, Noguchi K, Fujii H. Changes in masseter muscle blood flow during voluntary isometric contraction in humans. J Oral Rehabil. 2005 Aug;32(8):545-51. doi: 10.1111/j.1365-2842.2005.01461.x.'}, {'pmid': '9301384', 'type': 'BACKGROUND', 'citation': 'Abdulatif M, el-Sanabary M. Blood flow and mivacurium-induced neuromuscular block at the orbicularis oculi and adductor pollicis muscles. Br J Anaesth. 1997 Jul;79(1):24-8. doi: 10.1093/bja/79.1.24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is characterize the dose-effect relationship of rocuronium bromide at the adductor pollicis and masseter muscles using an pharmacokinetic-pharmacodynamic (PKPD) model. The hypothesis is that masseter muscle has a greater sensitivity to the neuromuscular blockers (rocuronium), faster onset and slower recovery profile than the adductor pollicis muscle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '10 ASA I-II patients, aged 18-65 years, scheduled for elective surgery under general anesthesia, were recruited.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for elective surgery under general anesthesia.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Body mass index (BMI) \\>25 kg/m2.\n* Anticipated difficult airway.\n* Surgery associated with great volume loss.\n* Presence of any neuromuscular, hepatic, renal, cardiac or respiratory disease.\n* Previous history of neuromuscular blockade allergy, and/or administration of drugs known to interfere with neuromuscular blockade'}, 'identificationModule': {'nctId': 'NCT02376595', 'briefTitle': 'Pharmacokinetic and Pharmacodynamic of Rocuronium', 'organization': {'class': 'OTHER', 'fullName': 'Pontificia Universidad Catolica de Chile'}, 'officialTitle': 'Pharmacokinetic and Pharmacodynamic of Rocuronium Bromide Measured in Adductor Pollicis and Masseter Muscles.', 'orgStudyIdInfo': {'id': '12-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rocuronium Bromide', 'description': 'Rocuronium 0,3 mg/kg administered in less than five seconds, followed by a saline bolus.', 'interventionNames': ['Drug: Rocuronium Bromide']}], 'interventions': [{'name': 'Rocuronium Bromide', 'type': 'DRUG', 'otherNames': ['Rocuronium Bromide Fresenius Kabi'], 'description': 'Rocuronium 0,3 mg/kg in less than five seconds, followed by a saline bolus.', 'armGroupLabels': ['Rocuronium Bromide']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Luis I Cortinez, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ponticia Universidad Católica'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pontificia Universidad Catolica de Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}