NCT00762372

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 20 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DRUG	desflurane	volatile liquid for inhalation
DRUG	desflurane/nitrous oxide	volatile liquid for inhalation with gas for inhalation
DRUG	sevoflurane/nitrous oxide	volatile liquid for inhalation and gas for inhalation

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2008-09-30
• Last updated: 2019-03-08
• Results posted: 2019-03-08

Locations

15 sites across 1 country: Japan