Healthy Clinical Trial
Official title:
Importance of Age as Covariable in the Requirements to Determine the Drug Plasma -Site Effect Equilibration Time for TCI Propofol Pharmacokinetic Models
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.
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.
;
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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