drugset / Trial / NCT01096212

Efficacy and Safety of Sevofran in Patients Scheduled for Elective Surgery Under General Anesthesia

NCT01096212

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

EvaluationDrugModalityDoseRoute
Subject Sevoflurane Other / unclassified Inhaled

Indications

No indication recorded.