[Neuromuscular blocking effects, pharmacokinetics and safety of Org 9426 (rocuronium bromide) in Japanese patients].
BACKGROUND
The purpose of this study was to examine pharmacodynamics, pharmacokinetics and safety of Org 9426 (rocuronium bromide) in Japanese patients.


METHODS
Seventy-eight patients anesthetized with thiopental, droperidol, fentanyl and nitrous oxide, were randomized to receive either a single dose of Org 9426 0.3 mg x kg(-1), 0.6 mg x kg(-1) or 0.9 mg x kg(-1). Contraction of the adductor pollicis to the ulnar nerve stimulation (0.1 Hz) was measured by acceleromyography. Blood was sampled over 6 hr and pharmacokinetic variables were calculated by plasma concentrations of Org 9426.


RESULTS
Onset times for patients receiving 0.3 mg x kg(-1), 0.6 mg x kg(-1) or 0.9 mg x kg(-1) were 271.5 s, 140.0s and 125.4s, respectively. There was a dose-dependent increase in clinical durations until 25% recovery of twitch height (17.4 min in 0.3 mg x kg(-1) group, 37.2 min in 0.6 mg x kg(-1) and 60.4 min in 0.9 mg x kg(-1) group). Pharmacokinetic study revealed that elimination half life, steady state volume of distribution and plasma clearance of Org 9426 were 48-76 min, 146-181 ml x kg(-1), and 3.8-4.5 ml x min(-1) x kg(-1), respectively. No adverse effects were found except a case of local erythema on a forearm.


CONCLUSIONS
The efficacy of neuromuscular block, stable pharmacokinetic behavior and excellent safety of Org 9426 were also confirmed in Japanese surgical patients.
Suzuki
Takahiro
T
Department of Anesthesiology, Surugadai Nihon University Hospital, Tokyo 101-8309.
Saeki
Shigeru
S
Takeda
Junzo
J
Ozaki
Makoto
M
Iwao
Yasuhide
Y
D000328:Adult; D000732:Androstanols / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000494:pharmacology*; D000762:Anesthesia Recovery Period; D000768:Anesthesia, General; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019148:Neuromuscular Blockade; D003473:Neuromuscular Nondepolarizing Agents / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000494:pharmacology*; D000077123:Rocuronium
D000732:Androstanols; D003473:Neuromuscular Nondepolarizing Agents; D000077123:Rocuronium