[Randomized, multicenter study of interaction between Org 9426 (rocuronium bromide) and anesthetic agents in Japanese population].
BACKGROUND
The purpose of this randomized, multi-center phase III trial was to investigate the influence of sevoflurane and propofol on the neuromuscular blocking effects and pharmacokinetic parameters of Org 9426 (rocuronium bromide) in Japanese population.


METHODS
Thirty-nine adult Japanese patients participated in this randomized, multi-center study. Neuromuscular function was monitored continuously with TOF-Watch SX (Organon NV, Netherlands) after anesthetic induction with propofol. These subjects randomly received either 0.6 mg x kg(-1) or 0.9 mg x kg(-1) of rocuronium for endotracheal intubation. These two groups were further divided to two anesthetic regiments : sevoflurane group and propofol group. The difference in onset and recovery of rocuronium-induced neuromuscular block was statistically analyzed with two-way ANOVA.


RESULTS
Mean duration for maximal block was 76 seconds and 66 seconds, respectively. The duration between Org 9426 administration and 25% recovery of first twitch response was significantly prolonged in patients given 0.9 mg x kg(-1) of Org 9426. Sevoflurane also significantly increased this duration. However, the serum concentration of Org 9426 was not statistically different between the four study groups.


CONCLUSIONS
The duration of Org 9426-induced neuromuscular blockade was significantly increased under sevoflurane anesthesia compared to propofol anesthesia. This difference may be attributed to pharmacodynamic change.
Kotake
Yoshifumi
Y
Department of Anesthesiology, School of Medicine, Keio University, Tokyo 160-8582.
Takeda
Junzo
J
Ozaki
Makoto
M
Saeki
Shigeru
S
Otagiri
Tetsutaro
T
Kiyama
Shuya
S
Uchimoto
Ryogo
R
Iwao
Yasuhide
Y
D000328:Adult; D000704:Analysis of Variance; D000732:Androstanols / Q000493:pharmacokinetics / Q000494:pharmacology*; D000762:Anesthesia Recovery Period; D000768:Anesthesia, General; D018685:Anesthetics, Inhalation; D018686:Anesthetics, Intravenous; D004347:Drug Interactions; D005260:Female; D006801:Humans; D008297:Male; D008738:Methyl Ethers; D008875:Middle Aged; D009469:Neuromuscular Junction / Q000187:drug effects* / Q000502:physiology; D003473:Neuromuscular Nondepolarizing Agents / Q000493:pharmacokinetics / Q000494:pharmacology*; D015742:Propofol; D000077123:Rocuronium; D000077149:Sevoflurane; D009435:Synaptic Transmission; D013997:Time Factors
D000732:Androstanols; D018685:Anesthetics, Inhalation; D018686:Anesthetics, Intravenous; D008738:Methyl Ethers; D003473:Neuromuscular Nondepolarizing Agents; D000077149:Sevoflurane; D000077123:Rocuronium; D015742:Propofol