Pharmacokinetic and Pharmacodynamic of Rocuronium

NCT ID: NCT02376595

Last Updated: 2015-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neuromuscular Blockade

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Rocuronium Bromide

Rocuronium 0,3 mg/kg administered in less than five seconds, followed by a saline bolus.

Rocuronium Bromide

Intervention Type DRUG

Rocuronium 0,3 mg/kg in less than five seconds, followed by a saline bolus.

Interventions

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Rocuronium Bromide

Rocuronium 0,3 mg/kg in less than five seconds, followed by a saline bolus.

Intervention Type DRUG

Other Intervention Names

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Rocuronium Bromide Fresenius Kabi

Eligibility Criteria

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Inclusion Criteria

* Scheduled for elective surgery under general anesthesia.

Exclusion Criteria

* Pregnancy.
* Body mass index (BMI) \>25 kg/m2.
* Anticipated difficult airway.
* Surgery associated with great volume loss.
* Presence of any neuromuscular, hepatic, renal, cardiac or respiratory disease.
* Previous history of neuromuscular blockade allergy, and/or administration of drugs known to interfere with neuromuscular blockade
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luis I Cortinez, MD

Role: STUDY_CHAIR

Ponticia Universidad Católica

References

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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.

Reference Type BACKGROUND
PMID: 7648768 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1673592 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20650376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21484503 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8092503 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10618945 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2751140 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15000421 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9605675 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17635389 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11065197 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23377654 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15000422 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 761446 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11927473 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11135721 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10434167 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16011632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9301384 (View on PubMed)

Other Identifiers

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12-003

Identifier Type: -

Identifier Source: org_study_id

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