External validation study for the Eleveld propofol pharmacokinetic-pharmacodynamic model

External validation study for the Eleveld propofol pharmacokinetic-pharmacodynamic model - Validation of the Eleveld propofol PKPD model

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46701

Enrollment

100

Registered

2018-07-18

Start date

2018-10-23

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Anesthesie bij operatie duur van 1 uur of langer narcosis sleepmedication

Interventions

Patients receive propofol according to the Eleveld PKPD model.

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: -* 3 years and older - American Society of Anesthesiologists (ASA) physical status 1-4 - Elective surgical procedure with an expected duration of 1 hour or more. - Need for an arterial line placement for the procedure - Written informed consent

Exclusion criteria

Exclusion criteria: - Contraindication for the use of propofol (e.g. allergy) - Inclusion in other studies preventing the use of propofol as primary hypnotic agent - Patients who have been admitted to the intensive care unit prior to surgery and/or have received propofol as sedation or anaesthesia in the 24 hours before the study.

Design outcomes

Primary

Measure	Time frame
Performance criteria (performance error, median (absolute) performance error, divergence, wobble) assessing the performance of the Eleveld PKPD model in the studied population.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)