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±0.6min in the BLM-240/N2O group and 14.3±0.9min 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.