title: A prospective randomized multicenter comparative study of BLM-240 (desflurane) versus sevoflurane in Japanese patients.
abstract: The present study was conducted to evaluate the efficacy and safety of BLM-240 (desflurane) in comparison to sevoflurane in Japanese patients. A total of 216 patients were enrolled in this randomized comparative study at 15 medical institutions. The patients received either BLM-240 with 50-70 % N2O in O2 (n = 111), BLM-240 with 30 % O2 in air (n = 55), or sevoflurane with 50-70 % N2O in O2 (n = 50). Efficacy was evaluated by an efficacy rate based on an efficacy evaluation criteria and recovery time to extubation from the discontinuation of the anesthetics. Safety was evaluated by incidence of adverse drug reactions (ADR) and other clinical indicators. The efficacy rate of BLM-240 was 98.8 % (164/166 patients), indicating that BLM-240 is effective as an anesthetic. Time from discontinuation of anesthetic delivery to extubation was 9.7 ± 0.6 min in the BLM-240/N2O group and 14.3 ± 0.9 min in the sevoflurane/N2O group, meeting the pre-defined non-inferiority criteria of BLM-240 to sevoflurane. There was no statistically significant difference in the incidence of total ADR between the BLM-240 group (62.0 %) and sevoflurane group (48.0 %). The results indicate that BLM-240 is an effective and safe inhalation anesthetic in Japanese patients.
authors.affiliation: Department of Anesthesiology, School of Medicine, Keio University, 35 Shinano-machi, Shinjuku-ku, Tokyo, Japan. jtakeda@z3.keio.jp
authors.forename: Junzo
authors.initials: J
authors.lastname: Takeda
authors.forename: Akiyoshi
authors.initials: A
authors.lastname: Namiki
authors.forename: Makoto
authors.initials: M
authors.lastname: Ozaki
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Fukuda
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Morita
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Kanmura
authors.forename: Michiaki
authors.initials: M
authors.lastname: Yamakage
authors.forename: Takami
authors.initials: T
authors.lastname: Komatsu
authors.forename: Eiichi
authors.initials: E
authors.lastname: Inada
authors.forename: Ryoichi
authors.initials: R
authors.lastname: Kawate
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kanazawa
authors.forename: Atsuhiro
authors.initials: A
authors.lastname: Sakamoto
authors.forename: Shoichi
authors.initials: S
authors.lastname: Uezono
authors.forename: Shigehito
authors.initials: S
authors.lastname: Sato
authors.forename: Kimitoshi
authors.initials: K
authors.lastname: Nishiwaki
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Miyamoto
authors.forename: Hideki
authors.initials: H
authors.lastname: Nakatsuka
authors.forename: Nobuhiko
authors.initials: N
authors.lastname: Yasuda
mesh_terms: D018685:Anesthetics, Inhalation / Q000008:administration & dosage* / Q000009:adverse effects*; D000077335:Desflurane; D005260:Female; D006801:Humans; D007530:Isoflurane / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D008297:Male; D008738:Methyl Ethers / Q000008:administration & dosage* / Q000009:adverse effects*; D008875:Middle Aged; D011446:Prospective Studies; D000077149:Sevoflurane
chemical_list: D018685:Anesthetics, Inhalation; D008738:Methyl Ethers; D000077149:Sevoflurane; D000077335:Desflurane; D007530:Isoflurane