MODELING OF GENERIC FORMULATIONS of SEVOFLURANE

COMPARATIVE POPULATION PHARMACODYNAMIC MODELING OF ORIGINAL AND GENERIC FORMULATIONS OF SEVOFLURANE USING BISPECTRAL INDEX IN GENERAL ANESTHESIA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001234

Enrollment

128

Registered

2014-09-19

Start date

2012-09-19

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : End-tidal concetration of inhalational anesthetics,Sevofrane and Sevorane on the induction and maintenance of anesthesia

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.For elective surgery 2. American Society of Anesthesiologists (ASA) physical status 1 or 2. 3. age is over 20 4. body weight is over 50 kg

Exclusion criteria

Exclusion criteria: Patients were excluded from the study if they had abnormal preoperative renal and hepatic function, had a history of drug or alcohol, psychiatric drug, or opioid in 14 days and had a body weight that was not within the 20% of ideal.

Design outcomes

Primary

Measure	Time frame
Pharmacodynamic analysis for the sevofrane and sevorane will be performed to assess the concentration-effect relationship through nonlinear mixed effect modeling.	—

Secondary

Measure	Time frame
Adverse events will be collected and reported;comparision of laboratory findings	—

Countries

Korea, Republic of

Contacts

Public ContactSEONGWOOK JEONG

Chonnam National University Hospital Hwasun Hospital

anesman@gmail.com

Outcome results