Development of a Pharmacodynamic Model for Propofol in Older Adults
Recruiting now · Not applicable
Conditions studied: Aged
In brief
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.
Key facts
- Study ID
- NCT05790720
- Run by
- Pontificia Universidad Catolica de Chile
- People needed
- 36
- Starts
- 2024-06-01
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2026-06-26
Who can join
Age: 65 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients undergoing non-cardiac elective surgery requiring general anesthesia
- American Society of Anesthesiologists Physical Status I to III
You may not qualify if…
- Patients undergoing emergency surgery
- Neurosurgical patients
- History of alcohol abuse or recreational drug use
- Known allergie to Propofol
- Body mass index ≥ 35 Kg m-2
- Unstable heart failure
Where it is running
- Pontificia Universidad Católica de Chile — Santiago, Santiago Metropolitan, Chile (enrolling)
Full record on ClinicalTrials.gov
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