Actively Recruiting

Phase Not Applicable
Age: 65Years - 99Years
All Genders
NCT05790720

Development of a Pharmacodynamic Model for Propofol in Older Adults

Led by Pontificia Universidad Catolica de Chile · Updated on 2025-05-31

60

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Development of a Pharmacodynamic Model for Propofol in Older Adults

Who Can Participate

Age: 65Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing non-cardiac elective surgery requiring general anesthesia
  • American Society of Anesthesiologists Physical Status I to III
  • Adults aged 65 to 99 years
Not Eligible

You will not qualify if you...

  • Patients undergoing emergency surgery
  • Neurosurgical patients
  • History of alcohol abuse or recreational drug use
  • Known allergy to Propofol
  • Body mass index 6 35 Kg/m2
  • Unstable heart failure

AI-Screening

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Trial Site Locations

Total: 1 location

1

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, Chile, 8330024

Actively Recruiting

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Research Team

J

Juan C. Pedemonte, MD

CONTACT

L

Luis I. Cortinez, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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