drugset / Trial / NCT01096212
Efficacy and Safety of Sevofran in Patients Scheduled for Elective Surgery Under General Anesthesia
Phase 4
Completed
178 enrolled
Asan Medical Center
National Clinical Research Coordination Center, Seoul, Korea · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2008-09
- Primary completion
- 2009-09
- Completion
- 2010-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sevoflurane | Other / unclassified | — | Inhaled |
Indications
No indication recorded.