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Validation of a pharmacologic profile of propofol

Validation of a pharmacologic profile of propofol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005474-77-BE
Enrollment
20
Registered
2005-12-13
Start date
2005-12-13
Completion date
Unknown
Last updated
2014-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Interventions

Sponsors

University Hospital Ghent
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged 18-65 years, scheduled for surgery requiring an arterial line to measure blood pressure and blood sampling for standard clinical practice (after normal Allan’s test ). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Weight less than 70% or more than 130% of ideal body weight, neurological disorder, and recent use of psycho-active medication, including alcohol.

Design outcomes

Primary

MeasureTime frame
Secondary Objective: ;Primary end point(s): Validation of the predicted propofol plasma concentration by the pharmacokinetic model using measured propofol plasma concentration. The model is accurate if the difference between the predited and the measured concentration is less than 25 % at a given time point.;Main Objective: To investigate if the calculated propofol plasma concentrations using the model published by Schnider et al. predicts accurately the measured plasma concentration of propofol during the first 5 minutes after a bolus dose given in 10 seconds or 3 minutes.

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026