Japan Phase 2/3 Clinical Study With BLM-240 (Desflurane)

Phase 2/3 Clinical Study With BLM-240 in Adult Surgery Patients That Need General Anesthesia

The purposes of this study are to evaluate the efficacy and safety of desflurane (BLM-240) as an anesthetic agent and to demonstrate the non-inferiority of desflurane to sevoflurane in term of awakening/recovery from anesthesia.

The study evaluates the efficacy and safety of the use of desflurane (BLM-240) (with and without nitrous oxide) in maintenance of general anesthesia in adult patients undergoing surgical procedures typically performed under general anesthesia in Japan (thoracic, abdominal, joints, back, and neck), where analgesics and muscle relaxants are concomitantly used. The study is also intended to demonstrate the non-inferiority of desflurane with nitrous oxide to sevoflurane with nitrous oxide in time to awakening/recovery.

Inclusion Criteria:

• ASA PS 1-3
• age: older than 19 y and younger than 70 y
• undergoing surgery of the thorax(thoracotomy, thoracotomy plus laparotomy, endoscopy; but excluding cardiovascular),abdomen(laparotomy,endoscopy;but excluding cesarean section), joints (including peripheral vessels), back (spine)or neck (neck, throat)
• willing to be hospitalized for at least 3 days and 2 nights (from the day before surgery to the day after surgery)
• having given written consent

Exclusion Criteria:

• need for spinal subarachnoid, epidural or local anesthesia (except local surface or infiltration anesthesia for catheter insertion or use of local anesthetic for testing before inserting epidural catheter for post-surgical pain)
• contraindication for use of nitrous during surgery
• anticipated need for postoperative transfer to intensive care unit and receive mechanical pulmonary ventilation
• BMI of 30 kg/m2 or more
• serious hepatic, renal, or circulatory disorder (Grade 3 per Notification 80 by MHW, Pharmaceutical Affairs Bureau, Safety Division)
• uncontrollable hypertension (SBP 160 mmHg or higher while on antihypertensive therapy)
• emergency surgery
• history of hypersensitivity to components of sevoflurane, fentanyl, propofol, vecuronium or other anesthetic
• contraindication to sevoflurane, fentanyl, propofol, or vecuronium
• exposure or suspected exposure to inhalational halogenated anesthetic within 3 mo prior to consent
• known or suspected history or family history of malignant hyperthermia
• considered likely to have difficulty in receiving tracheal intubation due to conditions such as brachygnathia, micrognathia, bucked teeth, articular rheumatism or injury of cervical spine/cervical cord
• known or suspected to be pregnant or lactating
• participated in a clinical study within 6 mo prior to consent
• history of drug dependence
• history of epilepsy
• otherwise judged by the investigator to be unsuitable for the study