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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: National Clinical Research Coordination Center, Seoul, Korea
• Treatments: Sevoflurane

Criteria

Inclusion Criteria:

• Patients scheduled for elective surgery under general anesthesia

• American Society Anesthesiologists Physical Status (ASA PS) 1 or 2

• Aged 19 years or above

Exclusion Criteria:

• ASA PS 3 or above

• aged under 19 years

• Contraindications against the use of sevoflurane

• Abnormal laboratory finding with clinical significance

• Evidence of pregnancy

• History of alcohol or drug abuse

• Hemoglobin < 11 mg/dl

• Neurological or psychiatric disease

• Unable or unwilling to give informed consent