A new propofol dosing method for people over 65 based on frontal EEG
Official title: Development of a Pharmacodynamic Model for Propofol in Older Adults (Development phaRmacodynamic mOdel Propofol oLdEr adulTs: DROPLET)
Run by Pontificia Universidad Catolica de Chile · NCT05790720 · Data updated 2026-11-12
We will test a new propofol dosing method that uses frontal EEG signals to guide anesthesia for people over 65 having non-cardiac elective surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years to 99 Years |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Pontificia Universidad Catolica de Chile Academic / other |
| Locations | 1 site (Santiago, Santiago Metropolitan) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | July 1, 2026 |
| Study ends | August 1, 2026 |
| Registry record updated | June 26, 2026 |
| Trial ID | NCT05790720 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults older than 65 scheduled for non-cardiac elective surgery under general anesthesia with ASA physical status I–III.
✕Probably not a fit
Patients undergoing emergency or neurosurgical procedures, those with BMI ≥35, unstable heart failure, active substance abuse, or a known propofol allergy are excluded and unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional pharmacodynamic project enrolls older adults who will receive propofol infusions while continuous frontal EEG and BIS are recorded. Investigators will use the Eleveld pharmacokinetic model to estimate plasma concentrations and derive a new pharmacodynamic parameter from intraoperative frontal EEG to represent drug effect. The study will compare the predictive performance of the standard Eleveld PKPD model based on BIS with the new EEG-derived model, correlating both with clinical signs of loss and return of consciousness. Participants will complete preoperative questionnaires and be monitored for safety during anesthesia at Pontificia Universidad Católica de Chile.
Why it matters
Potential benefit: If successful, the approach could let clinicians dose propofol more precisely in older adults, reducing overdose or underdose and improving safety and recovery.
How similar studies have gone: Existing PKPD models such as Eleveld's have performed across age ranges but relied on BIS and included few patients over 70, so using an EEG-derived PD parameter in older adults is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan, Chile Recruiting
Study contacts
- Study coordinator: Juan C. Pedemonte, MD
- Email: jcpedemo@gmail.com
- Phone: + 56 22 3543270
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.