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Sugammadex achieves fast recovery from shallow neuromuscular blockade induced by rocuronium or vecuronium: dose-response studies

9AP2-5

Pühringer, F.; Blaszyk, M.; Cammu, G.; Sparr, H.; Heeringa, M.

European Journal of Anaesthesiology (EJA): June 2007 - Volume 24 - Issue - p 111
Pharmacology
Free

Anaesthesia and Intensive Care Medicine, Klinikum am Steinenberg, Reutlingen, Germany

Background and Goal of Study: Sugammadex is the first selective relaxant binding agent (SRBA) designed to reverse the effects of rocuronium-induced neuromuscular blockade. This study assessed the effects of sugammadex on reversal of rocuronium- and vecuronium-induced shallow neuromuscular blockade.

Materials and Methods: One-hundred surgical patients (age 20- < 65 years, ASA class 1-3) were randomized to rocuronium (0.9 mg/kg, n = 50) or vecuronium (0.1 mg/kg, n = 50). Anaesthesia was induced using propofol and fentanyl and maintained with sevoflurane. Neuromuscular activity was monitored by acceleromyography (TOF-Watch® SX). Patients were randomised to sugammadex (0.5, 1.0, 2.0 or 4.0 mg/kg) or placebo at reappearance of T2. The primary end-point was the time from administration of sugammadex to recovery of the T4/T1 ratio to 0.9. An exponential model (and weighted non-linear regression) was used to explore the dose-response relation. Possible recurarization or residual curarization was assessed. Safety was evaluated by adverse events, vital signs and laboratory parameters.

Results and Discussion: Significant dose-response relations were found between sugammadex dose and time to T4/T1 ratio to 0.9 (Table).

Table

Table

A decrease from a T4/T1 ratio of ≥ 0.9 to <0.8 (indication for recurarisation) was reported for 7 subjects, predominantly in the 0.5 mg/kg group. SAEs were reported for three subjects, but none was considered related to sugammadex.

Conclusions: Sugammadex decreased recovery time from rocuronium- or vecuronium-induced neuromuscular blockade in a dose dependent manner. Sugammadex was safe and well tolerated.

© 2007 European Society of Anaesthesiology