Abstract
Background. Sugammadex is a selective relaxant binding agent designed to encapsulate the neuromuscular blocking agent, rocuronium. The sugammadex-rocuronium complex is eliminated by the kidneys. This trial investigated the pharmacokinetics (PKs) of sugammadex and rocuronium in patients with renal failure and healthy controls.MethodsFifteen ASA class II-III renal patients [creatinine clearance (CLCR) <30 ml min-1] and 15 ASA I-II controls (CLCR ≥80 ml min-1) were included. After induction of anaesthesia, a single i.v. dose of rocuronium 0.6 mg kg-1 was given, followed by a single i.v. dose of sugammadex 2.0 mg kg-1 at reappearance of the second twitch of the train-of-four response. Plasma concentrations of rocuronium and sugammadex were estimated and PK variables determined using non-compartmental analyses. Percentages of sugammadex and rocuronium excreted in the urine were measured.ResultsPK data were obtained from 26 patients. Mean total plasma clearance (CL) of sugammadex was 5.5 ml min -1 in renal patients and 95.2 ml min-1 in controls (P<0.05). Rocuronium CL was 41.8 ml min-1 in renal patients and 167 ml min-1 in controls (P<0.05). The median amount of sugammadex and rocuronium excreted in the urine over 72 h in renal patients was 29% and 4, respectively, and 73% and 42% over 24% h in controls.ConclusionsLarge differences in the PKs of sugammadex and rocuronium between patients with renal failure and healthy controls were observed. The effect of renal impairment on the PK variables of rocuronium was less than with sugammadex. Urinary excretion of both drugs was reduced in renal patients.
| Original language | English |
|---|---|
| Pages (from-to) | 31-39 |
| Number of pages | 9 |
| Journal | British Journal of Anaesthesia |
| Volume | 104 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Jan 2010 |
| Externally published | Yes |
Bibliographical note
Funding:This work was supported by Schering-Plough, Oss, The
Netherlands. The study sponsor was involved in the design
of the trial, the data validation and the analysis of the trial.
The authors were responsible for the interpretation of the
data and for writing the report. One of the authors is
employed by the sponsor (M.W.H.). The decision to
submit the paper for publication to this journal was made
by the authors.
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