An observational study in Propofol Overdose of Undetermined Intent, sponsored by Universidad del Desarrollo. Completed at 2 sites in Chile. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-29.
Sponsored by Universidad del Desarrollo · Observational
Despite the wide use of propofol target-controlled infusion (TCI) in elderly patients, pharmacokinetic (PK) and pharmacodynamic (PD) models performance has not been prospectively assessed in this population. The aims of this study are to derive four PKPD models using previously published PK parameters sets, and to prospectively assess their performance in elderly people. With the obtained data we propose to build a specific PKPD model for this population.
After BIS® and routine monitors were placed, 14 ASA I-II elderly patients (>65 yr) will be anesthetized with plasma TCI of propofol based on Schnider model. After partial recovery from a bolus dose a remifentanil infusion was started and continued throughout surgery. All BIS and TCI data will be continuously record. Arterial blood samples for propofol assays were collected at 1, 2, 3, 5, 10, 20, 40 and 60 min post-induction, and at 0, 1, 3, 5, and 10 min after stopping the infusion. A three compartment effect site model linked to a Sigmoidal Emax PD model, will be used to fit all the data simultaneously in NONMEM. Median performance errors(MDPE), and median absolute performance errors(MDAPE) were calculated to measure bias and accuracy of each model. Comparisons between models will be performed.
139 studies on the registry are indexed under Drug Overdose; 24 are open to participants now.
This study's enrollment of 14 is below the median of 175 across 38 observational studies indexed under Drug Overdose.
Browse Drug Overdose studies →Universidad del Desarrollo is the lead sponsor of 23 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients older than 65 years, ASA 1,2 programed for elective sugery
Exclusion Criteria:
Plan to share: Yes — Open TCI proyect
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidad del Desarrollo