▪ Smits et al. 2016 study13
Neonates admitted to the University Hospitals Leuven were eligible for
inclusion when a propofol i.v. bolus was administered for
procedural sedation for (semi-)elective endotracheal intubation.
Patients were included after parental written informed consent was
obtained. Approval of the study protocol was granted by the ethical
board of the University Hospitals Leuven, Belgium. Inclusion further
requested the absence of sedatives or analgesics, except acetaminophen
in the previous 24 hours and cardiovascular and hemodynamic stability
(judged by the attending neonatologist). The propofol dose at start of
the procedure, for each patient, was determined based on a dose-finding
approach13. Additional up-titration of the dose was
allowed based on clinical need. The initial and total propofol dose
ranges used in the study were 0.5-2 mg kg-1 and
0.5-4.5 mg kg-1 respectively13.
Blood samples for propofol quantification were collected at 3 h and/or
12 h after propofol administration. Samples (300-600 µL) were collected
from an arterial line if present, or venous puncture. The total blood
volume sampled in every neonate was limited to 1 mL
kg-1. Propofol quantification occurred by a sensitive
HPLC-fluorescence method developed and validated for small volumes.
Intra- and inter-day accuracy and precision were below 15%, and a LLOQ
of 0.0069 µg mL-1 was calculated. A detailed
description of the bioanalysis protocol has been published by Qi et
al.16.