Pharmacokinetic and Pharmacodynamic of Rocuronium

NCT02376595 | Completed DMC

• 1 other identifier: 12-003
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neuromuscular Blockade

Keywords

Rocuronium; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (2)

• strength measuring 2 acceleromyograph. One Placed at the masseter muscle and the other one at the adductor pollicis muscle.

  60 minutes

• Measure blood concentrations after administration rocuronium

  120 minutes

Study Arms (1)

Rocuronium Bromide

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

Drug: Rocuronium Bromide

Interventions

Rocuronium Bromide DRUG

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

Also known as: Rocuronium Bromide Fresenius Kabi

Rocuronium Bromide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

10 ASA I-II patients, aged 18-65 years, scheduled for elective surgery under general anesthesia, were recruited.

You may qualify if:

• Scheduled for elective surgery under general anesthesia.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Related Publications (19)

• 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: 7648768 BACKGROUND

• 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: 1673592 BACKGROUND

• 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: 20650376 BACKGROUND

• 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: 21484503 BACKGROUND

• 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: 8092503 BACKGROUND

• 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: 10618945 BACKGROUND

• 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: 2751140 BACKGROUND

• 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: 15000421 BACKGROUND

• 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: 9605675 BACKGROUND

• 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: 17635389 BACKGROUND

• 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: 11065197 BACKGROUND

• 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: 23377654 BACKGROUND

• 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: 15000422 BACKGROUND

• 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: 761446 BACKGROUND

• 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: 11927473 BACKGROUND

• 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: 11135721 BACKGROUND

• 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: 10434167 BACKGROUND

• 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: 16011632 BACKGROUND

• 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.

  PMID: 9301384 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples.

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Luis I Cortinez, MD

  Ponticia Universidad Católica

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: March 3, 2015
• Study Start: March 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: January 1, 2015
• Last Updated: March 3, 2015

Record last verified: 2015-02