Pharmacokinetic-pharmacodynamic model for the reversal of neuromuscular blockade by sugammadex

Anesthesiology

Volumn 110, Issue 1, 2009, Pages 95-105

  Ploeger, Bart A ^a,b   Smeets, Jean ^b   Strougo, Ashley ^b   Drenth, Henk Jan ^b   Ruigt, Ge ^c   Houwing, Natalie ^d   Danhof, Meindert ^b  

^a LAP and P Consultants BV   (Netherlands)

^b LEIDEN UNIVERSITY   (Netherlands)

^c MERCK RESEARCH LABORATORIES   (United States)

^d PHARMERIT INTERNATIONAL   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ROCURONIUM; SUGAMMADEX; VECURONIUM; GAMMA CYCLODEXTRIN DERIVATIVE;

AGE; ARTICLE; BODY HEIGHT; BODY WEIGHT; CALIBRATION; CAUCASIAN; COMPARTMENT MODEL; COMPLEX FORMATION; DISSOCIATION CONSTANT; DISTRIBUTION VOLUME; DRUG ANTAGONISM; DRUG BLOOD LEVEL; DRUG CLEARANCE; HUMAN; JAPANESE; MUSCLE TWITCH; NEUROMUSCULAR BLOCKING; NEUROMUSCULAR SYNAPSE; PHARMACODYNAMICS; PRIORITY JOURNAL; VOLUNTEER; BIOLOGICAL MODEL; COMPARATIVE STUDY; DOSE RESPONSE; DRUG EFFECT; DRUG INTERACTION; FEMALE; MALE; METABOLISM; METHODOLOGY; PHYSIOLOGY; RANDOMIZED CONTROLLED TRIAL; TIME;

DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG INTERACTIONS; FEMALE; GAMMA-CYCLODEXTRINS; HUMANS; MALE; MODELS, NEUROLOGICAL; NEUROMUSCULAR BLOCKADE; NEUROMUSCULAR JUNCTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TIME FACTORS;

EID: 58749110361     PISSN: 00033022     EISSN: 15281175     Source Type: Journal    
DOI: 10.1097/ALN.0b013e318190bc32     Document Type: Article

References (22)

1. Hunter JM, Flockton EA: The doughnut and the hole: A new pharmacological concept for anaesthetists. Br J Anaesth 2006; 97:123-6
2. de Boer HD, van Egmond J, van de Pol F, Bom A, Booij LH: Reversal of profound rocuronium neuromuscular blockade by sugammadex in anesthetized rhesus monkeys. ANESTHESIOLOGY 2006; 104:718-23
3. Epemolu O, Bom A, Hope F, Mason R: Reversal of neuromuscular blockade and simultaneous increase in plasma rocuronium concentration after the intravenous infusion of the novel reversal agent. Org 25969. ANESTHESIOLOGY 2003; 99:632-7
4. Gijsenbergh F, Ramael S, Houwing N, van Iersel T: First human exposure of Org 25969, a novel agent to reverse the action of rocuronium bromide. ANESTHESIOLOGY 2005; 103:695-703
5. Groudine SB, Soto R, Lien C, Drover D, Roberts K: A randomized, dosefinding, phase II study of the selective relaxant binding drug, sugammadex, capable of safely reversing profound rocuronium-induced neuromuscular block. Anesth Analg 2007; 104:555-62
6. Sparr HJ, Vermeyen KM, Beaufort AM, Rietbergen H, Proost JH, Saldien V, Velik-Salchner C, Wierda JM: Early reversal of profound rocuronium-induced neuromuscular blockade by sugammadex in a randomized multicenter study: Efficacy, safety, and pharmacokinetics. ANESTHESIOLOGY 2007; 106:935-43
7. Sorgenfrei IF, Norrild K, Larsen PB, Stensballe J, Ostergaard D, Prins ME, Viby-Mogensen J: Reversal of rocuronium-induced neuromuscular block by the selective relaxant binding agent sugammadex: A dose-finding and safety study. ANESTHESIOLOGY 2006; 104:667-74
8. Shields M, Giovannelli M, Mirakhur RK, Moppett I, Adams J, Hermens Y: Org 25969 (sugammadex), a selective relaxant binding agent for antagonism of prolonged rocuronium-induced neuromuscular block. Br J Anaesth 2006; 96: 36-43
9. Suy K, Morias K, Cammu G, Hans P, van Duijnhoven WG, Heeringa M, Demeyer I: Effective reversal of moderate rocuronium- or vecuronium-induced neuromuscular block with sugammadex, a selective relaxant binding agent. ANESTHESIOLOGY 2007; 106:283-8
10. de Boer HD, Driessen JJ, Marcus MA, Kerkkamp H, Heeringa M, Klimek M: Reversal of rocuronium-induced (1.2 mg/kg) profound neuromuscular block by sugammadex: A multicenter, dose-finding and safety study. ANESTHESIOLOGY 2007; 107:239-44
11. Sacan O, White PF, Tufanogullari B, Klein K: Sugammadex reversal of rocuronium-induced neuromuscular blockade: A comparison with neostigmineglycopyrrolate and edrophonium-atropine. Anesth Analg 2007; 104:569-74
12. Danhof M, de Jongh J, De Lange EC, Della Pasqua O, Ploeger BA, Voskuyl RA: Mechanism-based pharmacokinetic-pharmacodynamic modeling: Biophase distribution, receptor theory, and dynamical systems analysis. Annu Rev Pharmacol Toxicol 2007; 47:357-400
13. Bom A, Bradley M, Cameron K, Clark JK, Van Egmond J, Feilden H, MacLean EJ, Muir AW, Palin R, Rees DC, Zhang MQ: A novel concept of reversing neuromuscular block: Chemical encapsulation of rocuronium bromide by a cyclodextrin-based synthetic host. Angew Chem Int Ed Engl 2002; 41:266-70
14. Beal SL, Sheiner LB, Boeckmann AJ. NONMEM users guides. Ellicott City, Maryland; Icon Development Solutions; 1989-2006
15. Post TM, Freijer JI, Ploeger BA, Danhof M: Extensions to the Visual Predictive Check to facilitate model performance evaluation. J Pharmacokinet Pharmacodyn 2008; 35:185-202
16. Wierda JM, Proost JH, Schiere S, Hommes FD: Pharmacokinetics and pharmacokinetic/dynamic relationship of rocuronium bromide in humans. Eur J Anaesthesiol Suppl 1994; 9:66-74
17. 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; 58:185-91
18. De Haes A, Proost JH, Kuks JB, van den Tol DC, Wierda JM: Pharmacokinetic/ pharmacodynamic modeling of rocuronium in myasthenic patients is improved by taking into account the number of unbound acetylcholine receptors. Anesth Analg 2002; 95:588-96
19. Zhang L, Beal SL, Sheiner LB: Simultaneous versus sequential analysis for population PK/PD data II: Robustness of methods. J Pharmacokinet Pharmacodyn 2003; 30:405-16
20. Eleveld DJ, Kuizenga K, Proost JH, Wierda JM: A temporary decrease in twitch response during reversal of rocuronium-induced muscle relaxation with a small dose of sugammadex. Anesth Analg 2007; 104:582-4
21. Suzuki T, Saeki S, Takeda J, Ozaki M, Iwao Y: Neuromuscular blocking effects, pharmacokinetics and safety of Org 9426 (rocuronium bromide) in Japanese patients [Article in Japanese]. Masui 2006; 55:419-27
22. Nigrovic V, Bhatt SB, Amann A: Simulation of the reversal of neuromuscular block by sequestration of the free molecules of the muscle relaxant. J Pharmacokinet Pharmacodyn 2007; 34:771-88