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

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baxter Healthcare Corporation
• Treatments: Desflurane; Isoflurane; Nitrous Oxide; Sevoflurane

Criteria

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