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NCT01091350 Clinical Trial

Influence of Equilibration Rate Constant (ke0) of Propofol on the Effect Site Concentration for Loss of Consciousness

General Anesthesia Clinical Trial

Official title:
Influence of Equilibration Rate Constant (ke0) of Propofol on the Effect-site Concentration for Loss of Consciousness

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01091350
Other study ID # Orchestra vs Diprifusor
Secondary ID
Status Completed
Phase N/A
First received March 14, 2010
Last updated May 29, 2013
Start date May 2009
Est. completion date November 2009

Study information
Verified date May 2013
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The aim of this study is to validate that an effect compartment concentration for loss of consciousness (LOC) was varied according to different Keo value.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date November 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

- Adult patients undergoing general anesthesia

Exclusion Criteria:

- Hepatic or renal disease

- Drug addiction

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Intervention

Device:
• Diprifusor (Target-controlled infusion)
Two TCI devices with different Teo and same Marsh PK model
• Orchestra (Target-controlled infusion)
Two TCI devices with different Teo and same Marsh PK model

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Estimated effect-site propofol concentration at loss of consciousness after propofol infusion No
Secondary Time to loss of consciousness after propofol infusion No
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