Skip to content

Validation of the Eleveld propofol PKPD model

Validation study for the Eleveld propofol pharmacokinetic-pharmacodynamic model

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23552
Enrollment
100
Registered
2018-04-10
Start date
2018-05-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Anesthesiology, PKPD modeling

Interventions

This is a validation study where patients from a broad population (age-range, lean and obese) receive TCI propofol using the Eleveld model. Blood samples will be taken to measure plasma concentrations

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

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 (i.e. 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

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

Contacts

Public ContactR. Spanjersberg

Hanzeplein 1

r.spanjersberg@umcg.nl+31 (0)50 3611158

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)