Development of a Pharmacodynamic Model for Propofol in Older Adults
ConditionAged
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-99
SponsorPontificia Universidad Catolica de Chile
About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients undergoing non-cardiac elective surgery requiring general anesthesia
American Society of Anesthesiologists Physical Status I to III
Disqualifiers
Patients undergoing emergency surgery
Neurosurgical patients
History of alcohol abuse or recreational drug use
Known allergie to Propofol
Trial design
Design model
Single group
Treatments tested in this trial
Propofol
DrugPatients 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.
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Performance Error (PE)
Difference between the measured (according to Eleveld) and predicted concentrations, divided by the predicted concentration. Multiplied by 100. Unit of measure: percentage (%).
Time frame
Intravenous infusion start to one minute after start of burst suppression in EEGSecondary outcomes
1
Median Absolute Performance Error (MDAPE)
Median Absolute Performance Error (MDAPE) is the median PE and is a measure of how close the predicted concentration is to the measured concentration (Accuracy). Unit of measure: percentage (%).
Time frame
Intravenous infusion start to one minute after start of burst suppression in EEG2
Median Prediction Error (MDPE)
Median Prediction Error (MDPE) is a measure of the overall bias of the predictions; it indicates whether the model systematically overshoots or undershoots the target. Unit of measure: percentage (%).
Time frame
Intravenous infusion start to one minute after start of burst suppression in EEG3
Time of Loss of response (LOR)
Loss of response (LOR) is defined as the time when patients stop responding to verbal commands, light tactile stimulation, and the eyelid reflex. Unit of measure: time (seconds).
Time frame
Intravenous infusion start to one minute after start of burst suppression in EEG4
Time of Burst-suppression (BS)
Burst-suppression (BS) consists of alternating episodes of isoelectric flat EEG periods with bursts of slow waves, including systemic and quasiperiodic variation where high voltage and isoelectric periods have variations between and within bursts. Unit of measure: time (seconds).
Time frame
Intravenous infusion start to one minute after start of burst suppression in EEGSponsors and contacts
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Source ClinicalTrials.gov