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

NCT01096212 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2010-03-31

No results posted yet for this study

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.

Conditions

  • General Anesthesia
  • Sevoflurane
  • Generic Drugs

Interventions

DRUG

original sevoflurane

Sevoflurane content: 99.9985%, compound A: 4.6 ppm, water content (sample was opened, sealed and stored for 2 weeks): 0.072% w/v

DRUG

generic sevoflurane

Sevoflurane content: 99.99%, compound A: 3.8 ppm, water content (sample was opened, sealed and stored for 2 weeks) : 0.044% w/v

Sponsors & Collaborators

  • National Clinical Research Coordination Center, Seoul, Korea

    collaborator OTHER_GOV

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Gyu Jeong Noh, M.D. & Ph.D. · Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan College of Medicine

  • Sang Seok Lee, M.D. · Department of Anesthesiology and Pain Medicine, Sanggye-Paik Hospital, College of Medicine, Inje University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-09-30
Completion
2010-03-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01096212 on ClinicalTrials.gov