Influence of Premedication Protocols for Neonatal Endotracheal Intubation on Cerebral Oxygenation
NCT ID: NCT01427985
Last Updated: 2016-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
24 participants
INTERVENTIONAL
2011-06-30
2012-07-31
Brief Summary
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Detailed Description
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* Application of Atropin
* Application of Fentanyl
* Application of Mivacurium
* possible desaturation and / or bradycardia during intubation attempts
* restoration of arterial oxygen saturation and / or heart rate after succesful intubation
We aim to examine the change of the following parameters by the use of electrical cardiometry:
* stroke volume
* cardiac output
We compare two different premedication protocols and we evaluate the impact of these protocol on the time needed for intubation and on intubation difficulties .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Relaxation followed by analgosedation
Give Atropin, then Mivacurium, immediately followed by Fentanyl
Atropine, Fentanyl, Mivacurium
1. Atropin 10µg/kg
2. Mivacurium 200µg/kg immediately followed by
3. Fentanyl 2µg/kg
Analgosedation followed by Relaxation
Give atropin, then Fentanyl, then Mivacurium
Atropine, Fentanyl, Mivacurium
1. Atropin 10µg/kg
2. Fentanyl 2µg/kg, repeat max. two times
3. Mivacurium 200µg/kg
Interventions
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Atropine, Fentanyl, Mivacurium
1. Atropin 10µg/kg
2. Mivacurium 200µg/kg immediately followed by
3. Fentanyl 2µg/kg
Atropine, Fentanyl, Mivacurium
1. Atropin 10µg/kg
2. Fentanyl 2µg/kg, repeat max. two times
3. Mivacurium 200µg/kg
Eligibility Criteria
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Inclusion Criteria
* indication for elective or semi-elective endotracheal Intubation
* parental informed consent
Exclusion Criteria
44 Weeks
ALL
No
Sponsors
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University of Ulm
OTHER
Responsible Party
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Manuel Schmid
Dr. med.
Principal Investigators
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Manuel B Schmid, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University of Ulm
Locations
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University Medical Center
Ulm, Baden-Wurttemberg, Germany
Countries
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Other Identifiers
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ULMNEONIRS02
Identifier Type: -
Identifier Source: org_study_id
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