External validation study for the Eleveld propofol pharmacokinetic-pharmacodynamic model

Completed

• Conditions: Anesthesie bij operatie duur van 1 uur of langer; sleepmedication; narcosis

• Registration Number: NL-OMON46701
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

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

- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Performance criteria (performance error, median (absolute) performance error,<br /><br>divergence, wobble) assessing the performance of the Eleveld PKPD model in the<br /><br>studied population. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>na</p><br>