No registrations found.
ID
Source
Brief title
Health condition
Anesthesiology, PKPD modeling
Sponsors and support
Intervention
Outcome measures
Primary outcome
Performance criteria (performance error, median (absolute) performance error, divergence, wobble) assessing the performance of the Eleveld PKPD model in the studied population.
Secondary outcome
na
Background summary
Target controlled infusion (TCI) of anaesthetic drugs such as propofol allows for more stable plasma concentrations or effect, and is a clinically applied technique for drug administration during general anaesthesia. TCI requires reliable pharmacokinetic (PK) or pharmacokinetic/pharmacodynamic (PKPD) models for the specific drug. For propofol, many PK(PD) models are available, but are developed from many different populations and from different study protocols. Extrapolation of such models may pose risks of under- and/or overdosing of patients. The Eleveld PKPD model was developed using available data from many of these studies. The population from which this model is derived, is therefore far broader than any existing models, and application of this model is theoretically also much broader. However, this model has yet to be validated in a separate study, which is the aim of this current study.
Study objective
The Eleveld propofol PKPD model allows administration of propofol by use of target controlled infusion (TCI) in a broad population (children-adults-elderly-lean-obese).
Study design
close to 5, 10, 20, 30, 40 and 60 minutes after start of propofol TCI.
If operation takes longer than 60 minutes, samples will be taken at 30 minute intervals, with a maximum of 10 samples in total.
Intervention
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 of propofol and compared with predicted plasma concentrations. Bispectral index will be used as a surrogate measurement of propofol effect, and compared to predicted BIS and predicted effect-site concentrations.
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 (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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6958 |
| NTR-old | NTR7146 |
| Other | UMCG Research Register number : 201800282 |