N/A
Completed N=60
Propofol Pharmacokinetics and Pharmacodynamics Modelling
Intravenous Anesthetic Agent Overdose
Source: ClinicalTrials.gov NCT02713698 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Plasma Propofol Concentration (mcg/mL) — 2.36; 3.12; 2.91 mcg/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Propofol Concentration (mcg/mL) |
2.36; 3.12; 2.91 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02713698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.