A Phase 4 interventional study of Atropine, Fentanyl, Mivacurium and Atropine, Fentanyl, Mivacurium in Newborn, Preterm and Intubation, sponsored by University of Ulm. Completed at 1 site in Germany. Open to participants aged Up to 44 Weeks. Per ClinicalTrials.gov, last updated 2016-04-06.
Sponsored by University of Ulm · Phase 4, Interventional, and Treatment
The purpose of this study is to examine the influence of premedication drugs Atropin, Fentanyl and Mivacurium and of endotracheal intubation on cerebral oxygenation and cardiac output in term and preterm newborn infants. Two different protocols of premedication are compared.
Influence of the following procedures will be examined:
We aim to examine the change of the following parameters by the use of electrical cardiometry:
We compare two different premedication protocols and we evaluate the impact of these protocol on the time needed for intubation and on intubation difficulties .
2,610 studies on the registry are indexed under Premature Birth; 507 are open to participants now.
This study's enrollment of 24 is below the median of 84 across 1,722 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University of Ulm is the lead sponsor of 143 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Give Atropin, then Mivacurium, immediately followed by Fentanyl
Drug: Atropine, Fentanyl, Mivacurium
Give atropin, then Fentanyl, then Mivacurium
Drug: Atropine, Fentanyl, Mivacurium
Drug pages: Atropine · Fentanyl · Mivacurium
1. Atropin 10µg/kg 2. Mivacurium 200µg/kg immediately followed by 3. Fentanyl 2µg/kg
Drug pages: Atropine · Fentanyl · Mivacurium
1. Atropin 10µg/kg 2. Fentanyl 2µg/kg, repeat max. two times 3. Mivacurium 200µg/kg
Change of cerebral tissue oxygen saturation during premedication and intubation
A baseline value of cerebral tissue oxygen saturation before first application of premedication drugs is determined. Change of cerebral tissue oxygen saturation is defined as area under this threshold from first drug application until recovery.
Time frame: from 1 minute before first study drug until 10 minutes after end of procedure
The record gives a start of Jun 2011, a primary completion of Jul 2012 and a completion of Jul 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Atropine · Fentanyl · Mivacurium