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

Baxter

Status and phase

Completed

Phase 3

Phase 2

Conditions

Anesthesia

Treatments

Drug: desflurane/nitrous oxide

Drug: desflurane

Drug: sevoflurane/nitrous oxide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00762372

BLM-240-003

Details and patient eligibility

About

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.

Full description

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.

Enrollment

216 patients

Sex

All

Ages

20 to 69 years old

Volunteers

No Healthy Volunteers

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