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Clinical Trial Summary

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).


Clinical Trial Description

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). ;


Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01621373
Study type Interventional
Source Universitaire Ziekenhuizen Leuven
Contact
Status Completed
Phase Phase 2
Start date August 2012
Completion date July 2014

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