Prospective clinical evaluation of the Eleveld pharmacokinetic and pharmacodynamic model of propofol for moderate-to-deep sedation in adults.

Abstract

Background: Target-controlled infusion (TCI) based on pharmacokinetic- and pharmacodynamic (PKPD) models is widely used for procedural moderate to deep sedation (MDS) outside of the operating room. Recently, PKPD models developed for broad populations such as the Eleveld model have become commercially available and are thought to be suitable for TCI during MDS. As clinical experience and guidelines are lacking, we aimed to evaluate the Eleveld propofol model for MDS and to find normative values of propofol effect-site target concentrations for MDS.

Methods: We considered three patient groups: adult, elderly, and obese, with 25 patients for each group. Primary outcomes were maintaining adequate respiratory and haemodynamic parameters and successful completion of the planned procedures. Secondary outcomes were clinically relevant endpoints on the procedure timeline and the occurrence of adverse events.

Results: We found that targets with the Eleveld propofol model are generally between 2-3 μg ml -1 for adults and nearer to 2 μg ml -1 for elderly and obese individuals, and do not require much adaptation during the procedure. Clinicians may observe slightly increased blood pressure and heart rate during the procedure and interpret this as a sign of patient stimulation, and in response increase target concentrations. Respiration rate and SpO 2 decrease slightly with increased predicted drug effect.

Conclusion: The Eleveld propofol model can be used in TCI to achieve MDS while maintaining adequate respiratory and hemodynamic parameters, resulting in the safe completion of the planned procedures.