CompletedNot Applicable

Propofol Pharmacokinetics and Pharmacodynamics Modelling

Portugal60 participantsStarted 2016-04-01

Plain-language summary

The main purpose of this research is to develop a population pharmacokinetic and pharmacodynamic model of Propofol when used for induction and maintenance of anaesthesia, using BIS as a pharmacodynamic endpoint. A covariate analysis will be performed in order to account for variability in pharmacokinetic and pharmacodynamic parameters. The influence of age and obesity on propofol pharmacokinetic parameters will be particularly addressed.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients admitted for nose or ear surgery, bariatric surgery or urgent orthopaedic surgery. Exclusion Criteria: * Severe hepatic or renal insufficiency; * Significant haemodynamic instability previous to the surgery; * Allergy to eggs or propofol at the time of enrolment; * Predictive criteria for difficult airway management.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Plasma Propofol Concentration (mcg/mL)

Timeframe: up to 2 hours

Trial details

NCT IDNCT02713698

SponsorCentro Hospitalar do Porto

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-04

Results submitted2018-01-24

View on ClinicalTrials.gov More Intravenous Anesthetic Agent Overdose trials