Optimizing Propofol Dosing for (Preterm) Newborn Infants That Need Endotracheal Intubation (NEOPROP2)
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|ClinicalTrials.gov Identifier: NCT02040909|
Recruitment Status : Terminated (interim results concluded no added value of additional inclusion)
First Posted : January 20, 2014
Last Update Posted : February 1, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia Intubation Complication Premature Birth of Newborn Other Preterm Infants Propofol Overdose||Drug: Propofol||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimizing Propofol Dosing for (Preterm) Newborn Infants That Need Endotracheal Intubation|
|Actual Study Start Date :||July 2014|
|Actual Primary Completion Date :||January 23, 2018|
|Actual Study Completion Date :||January 23, 2018|
A predetermined propofol dose is used in every 5 consecutive patients per age group. Starting dose is 1.0 mg/kg. Dose is increased or decreased with 0.5 mg/kg
Propofol, an anesthetic agent, is used to sedate the patients before endotracheal intubation. The propofol starting dose in all age groups will be 1.0 mg propofol/kg. After 5 patients per age group the next dose will be determined. Dose will be increased or decreased with 0.5 mg/kg for the next 5 patients. The study will be continued untill an adequate dose, that results in adequate sedation, good intubation conditions without hypotension, is determined. That dose will be valideted in another 5 patients per age group.
Other Name: Diprivan
- adequate propofol dose [ Time Frame: 24 hours ]
Adequate propofol doses are determined by 3 co-primary outcome variables:
- Adequate sedation
- Optimal intubation conditions
- No hypotension or other severe side effects
- Determine a valid sedation assessment scale [ Time Frame: 24 hours ]To develop a validated and useful sedation assessment instrument for (preterm) newborns during endotracheal intubation. For this aim validated pain assessment instruments (COMFORTneo, neonatal Pain And Sedation Scale, Premature Infant Pain Profile and Neonatal Infant Pain Scale will be compared with an available sedation score by the use of videotapes. Furthermore we aim to determine the relationship between these pain and sedation scores with the patients stress level as measured by cortisol levels.
- to determine an age specific propofol PK/PD model [ Time Frame: 24 hours ]Pharmacodynamic data of propofol are explored (duration of intubation, duration of sedation, time of side effect, recovery of spontaneous breathing). We will analyze propofol concentrations in a pharmacokinetic model and integrate pharmacodynamic data (level of sedation, side effects) and covariates (age, weight, morbidity, etc). We aim to determine effective propofol concentrations and concentrations that might result in side-effects.
- aEEG / NIRS [ Time Frame: 24 hours ]-To further explore dose and age-related hemodynamic effects of propofol. Next to blood pressure and heart rate cerebral oxygenation and continuous amplitude-integrated EEG (aEEG) will be monitored. After the intubation procedure, when the patient is still sedated the cerebral perfusion is measured using cerebral Doppler sonography. In this way we aim to determine the effects of propofol on cerebral perfusion. Risk factors for hypotension and cerebral hypoperfusion are determined.
- Propofol polymorphisms on effect and metabolizing enzymes [ Time Frame: 1 year ]To further explain expected inter-individual variability in propofol concentrations and effects by adding genotypic variability to the PK/PD model. Polymorphisms in genes encoding propofol metabolizing enzymes (UGT 1A9 and Cytochrome P450 2B6) and GABA (gamma-aminobutyric acid) receptors will be analysed in the patients DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02040909
|VU Medical Center|
|Amsterdam, Netherlands, 1081HZ|
|Erasmus MC Sophia Children's Hospital|
|Rotterdam, Netherlands, 3000CB|
|Maxima Medisch Centrum|
|Veldhoven, Netherlands, 5504 DB|
|Study Director:||Mirjam van Weissenbruch, MD PhD||VU Medical Center Amsterdam|