Development of a Pharmacodynamic Model for Propofol in Older Adults

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pontificia Universidad Catolica de Chile
• Treatments: Propofol

Criteria

Inclusion Criteria:

• Patients undergoing non-cardiac elective surgery requiring general anesthesia

• American Society of Anesthesiologists Physical Status I to III

Exclusion Criteria:

• 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