Adverse Reaction to Drug Clinical Trial
Official title:
Prospective Exploratory Dose-finding Study in Neonates Receiving a Single Intravenous Propofol Bolus for Endotracheal Intubation During (Semi-)Elective INSURE Procedure or Non-INSURE Procedures in Neonates
The aim of the study is to explore the optimal propofol dose in neonates receiving a single intravenous propofol bolus for endotracheal intubation during (semi-)elective INSURE (intubation-surfactant-extubation) procedure (preterm neonates) and (semi-)elective non-INSURE procedures (term-preterm neonates).
The aim of the study is to evaluate the pharmacokinetics and pharmacodynamics of propofol
(short acting anesthetic) in 50 neonates to whom the drug is administered as a intravenous
bolus. This is part of routine clinical care in patients receiving (semi-) elective
intubation. It's the aim to explore the most effective IV propofol dose for a successful
INSURE (intubation, surfactant, extubation) procedure and for successful (semi-) elective
intubation in non-INSURE procedures. We hereby aim to define the most optimal dose regimen
for propofol in neonates.
we will hereby use
- predefined scoring systems to evaluate sedation, relaxation and intubation conditions
- vital parameter monitoring
- pharmacokinetic analysis with blood samples
- brain monitoring with NIRS (Near infrared spectroscopy) derived cerebral oxygenation
and aEEG (amplitude integrated EEG).
;
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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