NCT01096212

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 31, 2010

Completed
Last Updated

March 31, 2010

Status Verified

March 1, 2010

Enrollment Period

1 year

First QC Date

March 29, 2010

Last Update Submit

March 30, 2010

Conditions

General AnesthesiaSevofluraneGeneric Drugs

Keywords

EfficacyMinimum alveolar concentrationSafetySevoflurane

Outcome Measures

Primary Outcomes (1)

  • Comparison of mean minimum alveolar concentration between original and generic sevoflurane

    Minimum alveolar concentration was determined by end-tidal sevoflurane concentrations. Mean MAC was calculated as following equation, Mean MAC = (MAC \* hour) / (maintenance time from administration of hypnotic agent (propofol) for acquring loss of consciousness to extubation)

    During mainenance of anesthesia under general anesthesia

Secondary Outcomes (1)

  • Comparison of secondary efficacy and safety endpoints between two inhalation agents

    During maintenance of anesthesia under general anesthesia

Study Arms (2)

generic sevoflurane

EXPERIMENTAL
Drug: generic sevoflurane

origianl sevoflurane

ACTIVE COMPARATOR
Drug: original sevoflurane

Interventions

original sevofluraneDRUG

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

Also known as: Sevorane® (Abott Korea Ltd, Seoul, Korea)
origianl sevoflurane
generic sevofluraneDRUG

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

Also known as: Sevofran® (Hana Pharmacy, Co. Ltd, Seoul, Korea)
generic sevoflurane

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective surgery under general anesthesia
  • American Society Anesthesiologists Physical Status (ASA PS) 1 or 2
  • Aged 19 years or above

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Sanggye-Paik Hospital

Seoul, 139-707, South Korea

Location

Related Publications (1)

  • Byon HJ, Choi BM, Bang JY, Lee EK, Lee SS, Noh GJ. An Open-label Comparison of a New Generic Sevoflurane Formulation With Original Sevoflurane in Patients Scheduled for Elective Surgery Under General Anesthesia. Clin Ther. 2015 Apr 1;37(4):887-901. doi: 10.1016/j.clinthera.2015.01.012. Epub 2015 Feb 16.

    PMID: 25697421DERIVED

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Gyu Jeong Noh, M.D. & Ph.D.

    Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan College of Medicine

    STUDY CHAIR

  • Sang Seok Lee, M.D.

    Department of Anesthesiology and Pain Medicine, Sanggye-Paik Hospital, College of Medicine, Inje University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 29, 2010

First Posted

March 31, 2010

Study Start

September 1, 2008

Primary Completion

September 1, 2009

Study Completion

March 1, 2010

Last Updated

March 31, 2010

Record last verified: 2010-03

Locations

KR(2)