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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relaxation followed by analgosedation | Experimental | Give Atropin, then Mivacurium, immediately followed by Fentanyl |
|
| Analgosedation followed by Relaxation | Active Comparator | Give atropin, then Fentanyl, then Mivacurium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine, Fentanyl, Mivacurium | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from 1 minute before first study drug until 10 minutes after end of procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel B Schmid, Dr. med. | University of Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center | Ulm | Baden-Wurttemberg | 89075 | Germany |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| D005283 | Fentanyl |
| D000077590 | Mivacurium |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Atropine, Fentanyl, Mivacurium | Drug |
|
|
| D000091642 | Urogenital Diseases |
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |