Clinical Trial

Development of a Pharmacodynamic Model for Propofol in Older Adults

Study acronym: DROPLET
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated June 26, 2026 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this pharmacodynamic study is to develop a model for Propofol administration for older adults (\>65 years). The main objective is to create a model based on a new pharmacodynamic parameter, derived from frontal electroencephalogram (EEG), to admininster Propofol in older adults. With this new model, the investigators aim to: * Evaluate the relationship between the plasmatic concentration, described by the Eleveld pharmacokinetic model, versus the effect of the drug represented with a new parameter derived from the intraoperative frontal EEG. * To validate the predictive ability of Eleveld's pharmacokinetic-pharmacodynamic model, based on the bispectral index (BIS), compared to the new model based on a parameter derived from intraoperative frontal EEG. Participants will be asked to answer preoperative questionnaires, receive a Propofol intravenous infusion concomitantly with continuous BIS and EEG monitoring, and to be evaluated for clinical sings of loss and return of consciousness.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-03-16; most recent amendment 2026-06-23.
Status change: Not Yet Recruiting → Recruiting 2025-05-27
Trial Details
NCT Number NCT05790720
Lead Sponsor Pontificia Universidad Catolica de Chile
Conditions Aged
Enrollment 36 participants
Start Date 2024-06-01
Primary Completion 2026-07-01 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-26