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RECRUITING
NCT05790720
NA

Development of a Pharmacodynamic Model for Propofol in Older Adults

Sponsor: Pontificia Universidad Catolica de Chile

View on ClinicalTrials.gov

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.

Official title: Development of a Pharmacodynamic Model for Propofol in Older Adults (Development phaRmacodynamic mOdel Propofol oLdEr adulTs: DROPLET)

Key Details

Gender

All

Age Range

65 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-06-01

Completion Date

2025-08-01

Last Updated

2025-05-31

Healthy Volunteers

No

Conditions

Interventions

DRUG

Propofol

Patients older than 65 years of age will receive an intravenous infusion of Propofol with prespecified plasma targets. During its administration, registration of BIS values, frontal electroencephalography, and clinical signs of consciousness will be performed.

Locations (1)

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, Chile