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.
References
Saros GB, Doolke A, Anderson RE, Jakobson JG. Desflurane vs. sevoflurane as the main inhaled anaesthetic for spontaneous breathing via a laryngeal mask for varicose vein day surgery: a prospective randomized study. Acta Anaesthesiol Scand. 2006;50:549–52.
Meco M, Cirri S, Gallazzi C, Magnani G, Cosseta D. Desflurane preconditioning in coronary artery bypass graft surgery a double-blinded, randomised and placebo-controlled study. Eur J Cardiothorac Surg. 2007;32:319–25.
Ro¨rtgen D, Kloos J, Fries M, Grottke O, Rex S, Rossaint R, Coburn M. Comparison of early cognitive function and recovery after desflurane or sevoflurane anaesthesia in the elderly. Br J Anaesth. 2010;104:167–74.
Makkar KJ, Ghai B, Bhardwaj N, Wig J. Minimum alveolar concentration of desflurane with fentanyl for laryngeal mask airway removal in anesthetized children. Pediatric Anesth. 2012;22:335–40.
Yasuda N, Targ AG, Eger EI II. Solubility of I-653, sevoflurane, isoflurane, and halothane in human tissues. Anesth Analg. 1989;69:370–3.
Bilotta F, Doronzio A, Cuzzone V, Caramia R, Rosa G, PINOCCHIO Study Group. Early postoperative cognitive recovery and gas exchange patterns after balanced anesthesia with sevoflurane or desflurane in overweight and obese patients undergoing craniotomy: a prospective randomized trial. J Neurosurg Anesthesiol. 2009;21:207–13.
McKay RE, Malhotra A, Cakmakkaya OS, Hall KT, McKay WR, Apfel CC. Effect of increased body mass index and anaesthetic duration on recovery of protective airway reflexes after sevoflurane vs desflurane. Br J Anaesth. 2010;104:175–82.
Baxter company internal report. A final report of the safety and pharmacokinetics of BLM-240 in surgery patients. 2009.
Nishiyama T, Yokoyama T, Hanaoka K. Effects of sevoflurane and isoflurane anesthesia on arterial ketone body ratio and liver function. Acta Anaesthesiol Scand. 1999;43:347–51.
Conflict of interest
Junzo Takeda and Nobuhiko Yasuda have received a consulting fee from Baxter Ltd and all the other authors have no conflict of interest. This study was sponsored by Baxter Healthcare Corporation.
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Takeda, J., Namiki, A., Ozaki, M. et al. A prospective randomized multicenter comparative study of BLM-240 (desflurane) versus sevoflurane in Japanese patients. J Anesth 27, 468–471 (2013). https://doi.org/10.1007/s00540-012-1536-x
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DOI: https://doi.org/10.1007/s00540-012-1536-x