Efficacy and Safety of Sevofran in Patients Scheduled for Elective Surgery Under General Anesthesia
Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
Participant gender:
Summary
Sevoflurane is currently being used in more than 100 countries worldwide with an estimated
100 million operations having been performed using sevoflurane as a general anesthetic. After
the expiry of the patent on sevoflurane as a pharmaceutical drug, a generic product
(Sevofran®; Hana pharmacy, Co. Ltd, Seoul, Korea) has been launched. The aims of this study
were to investigate the efficacy (mean minimum alveolar concentration), recovery
characteristics (time to recovery of consciousness (ROC) and recovery, and BIS values at ROC
and orientation), and safety (incidence and severity of adverse events) of generic
sevoflurane in patients undergoing elective surgery.
Phase:
Phase 4
Details
Lead Sponsor:
Asan Medical Center
Collaborator:
National Clinical Research Coordination Center, Seoul, Korea