NCT05790720 Development of a Pharmacodynamic Model for Propofol in Older Adults
| NCT ID | NCT05790720 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pontificia Universidad Catolica de Chile |
| Condition | Aged |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2025-07-01 |
Trial Parameters
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Brief 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.
Eligibility 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