Clinical trial

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

Name

230125002

Description

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.

Trial arms

Trial start

2024-06-01

Estimated PCD

2025-07-01

Trial end

2025-08-01

Status

Not yet recruiting

Treatment

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.

Arms:

Intervention

Size

Primary endpoint

Performance Error (PE)

Intravenous infusion start to one minute after start of burst suppression in EEG

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pharmacokinetic-pharmacodynamic model that uses the pharmacokinetic parameters of the Eleveld model and new pharmacodynamic parameters derived from frontal EEG in a population older than 65 years.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2024-06-04

1 organization

1 product

1 indication

Organization

Pontificia Universidad Catolica de Chile

Product

Propofol

Indication

Elderly