Optimizing Propofol Dosing for (Preterm) Newborn Infants That Need Endotracheal Intubation
Status:
Terminated
Trial end date:
2018-01-23
Target enrollment:
Participant gender:
Summary
Newborns admitted to an intensive care unit often require artificial ventilation. For that
purpose an endotracheal tube needs to be placed into the trachea, a procedure named
endotracheal intubation. The newborns need to be sedated to keep them comfortable, to stop
moving and to relax in order to enable the success of the procedure. For this sedation an
anesthetic agent named propofol is often used. The used dose of propofol has not been
properly studied and as a consequence patients are under- or over -sedated and propofol leads
to side effects such as hypotension.
The current study aims to find the most appropriate dose of propofol for newborns of
different gestational ages and of different post-natal ages. We will use propofol in
different doses and after each 5 included patients per age group we will analyze whether the
dose needs to be increased or decreased. The effect of the propofol will be extensively
monitored and we will study the level of sedation, the quality of intubation, the stability
of the patient en the occurrence of side effects.
At the end we aim to have appropriate guidelines for propofol doses in newborns of all ages.
Phase:
Phase 1
Details
Lead Sponsor:
Erasmus Medical Center
Collaborators:
Maxima Medical Center Stichting Nuts Ohra VU University Medical Center ZonMw: The Netherlands Organisation for Health Research and Development