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OpenTrials
Completed

NCT Number: NCT01586013

the Effect Site Equilibration Time of Propofol is Age Dependant

This study obtains an effect site model for White (Modified Marsh) pharmacokinetic propofol model. The plasma effect-site rate constant (ke0) obtained is affected by age.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinica Alemana

Santiago, 7650670, Chile

About this study

In the Target Controlled Infusion pumps the first order plasma-effect-site steady-state rate constant (ke0) links the pharmacokinetics (PK) and pharmacodynamics (PD) for a given drug and it is used to predict the course of the effect and to calculate a theoretical drug concentration at the effect site. The PK model for propofol recently published by White et al. (derived from the Marsh model used by the Diprifusor®) include covariate as age and gender to describe the pharmacokinetics but does not incorporate a ke0.

Methods: 45 healthy adult patients will be scheduled for elective surgery with standard monitoring and BIS XP (Aspect) will received a White PK model-driven plasma target controlled infusion of propofol ( 12 ugml-1 or 10 ugml-1 over 65 years) to be reached in 4 min. After reaching the target, the infusion will be stopped obtaining a complete effect curve upon patient awakening. Calculated plasma concentration and EEG data were stored every one second. Loss (LOC) and recovery (ROC) of consciousness were assessed and recorded. The dynamic relationship between propofol Ce and its effect as measured by BIS will be modeled with an inhibitory Emax model using a population PK/PD approach with NONMEM V.

the Study take around 12 min.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA 1-2

Exclusion criteria

  • less than 70% or more than 130% ideal body mass index,
  • neurologic disorders,
  • pregnancy,
  • psychoactive medication intake during last 48 hours

Treatment and study plan

evaluation of propofol effect using BIS

Drug

propofol administered in target controlled infusion using the pharmacokinetic model of White

Other names: evaluation of effect of intravenous di-isopropilfenol

Primary outcomes

  1. pharmacodynamic model for the White propofol pharmacokinetic

    Time frame: Bispectral index

    Using a propofol target controlled infusion using de White propofol model, we evaluate a complete curve of depression and recovery of the BIS

Sponsors and collaborators

Lead sponsor

Universidad del Desarrollo

Other

Registry information

Official study title

Importance of Age as Covariable in the Requirements to Determine the Drug Plasma -Site Effect Equilibration Time for TCI Propofol Pharmacokinetic Models

Acronym: ke0agedep

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 26, 2012
Registry last updated
Apr 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.