Hypnotic Effect Clinical Trial
Official title:
Modelling Pharmacokinetic/Pharmacodynamic of Propofol Based on PSI Values From the SEDline®
The purpose of this study is the evaluation of possible relationships and correlation between PSI values obtained from the SEDLine® monitor and the infusion rate of propofol during general anesthesia.
Introduction:
There is a large intra-and interindividual variability in the effect of propofol. To deal
with this problem, a real-time monitoring and therefore a more accurate titration of
anesthetic agents is proposed. Brain function monitors based on a processed analysis of EEG
(Electroencephalogram) can help to control pharmacodynamic effects of hypnotic agents. PSI
values provide a measurement of the hypnotic effect of propofol. It will be observed an
inverse correlation between the propofol infusion rate and the PSI value.
Objectives:
To design a computer program to record simultaneously the propofol infusion rate, PSI and
Electromyogram (EMG).
To study the correlation between PSI values obtained from the SEDLine® monitor and the
infusion rate of propofol during general anesthesia.
To obtain a mathematical model of the system from data recorded with different identification
techniques.
Methods:
A group of patients scheduled for surgery under a standard total intravenous anesthesia
(TIVA) with propofol and remifentanil will be recruited. The hypnotic effect of propofol will
be monitored with the PSI from a SEDline monitor continuously. All anesthetic doses and their
changes fall within conventional dosing.
The procedure for recording data and obtaining the pharmacokinetics/pharmacodynamics (PK /
PD) model will be connecting a SEDLine® monitor to a laptop with an original program
developed by members of our team. The program automatically stores the infusion rate of
propofol (mg/kg/h) and the simultaneous values of PSI and frontal EMG. Graphics and data
collected will be explored with various systems of techniques for pattern recognition in
order to get the best fit to define a mathematical model of the dose of propofol and PSI
values. A subsequent computer analysis with MATLAB® will estimate the correlation between the
infusion of propofol infusion rate and PSI values.
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