Influence of Premedication Protocols for Neonatal Endotracheal Intubation on Cerebral Oxygenation

• Sponsor: University of Ulm (Other)
• Overall Status: Completed
• CT.gov ID: NCT01427985
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Newborn; Preterm; Intubation	Drug: Atropine, Fentanyl, Mivacurium; Drug: Atropine, Fentanyl, Mivacurium	Phase 4

Detailed Description

Influence of the following procedures will be examined:

• 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 .

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Influence of Two Different Premedication Protocols for Endotracheal Intubation in Neonates on Cerebral Oxygenation
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Relaxation followed by analgosedation Give Atropin, then Mivacurium, immediately followed by Fentanyl	Drug: Atropine, Fentanyl, Mivacurium; Atropin 10µg/kg Mivacurium 200µg/kg immediately followed by Fentanyl 2µg/kg
Active Comparator: Analgosedation followed by Relaxation Give atropin, then Fentanyl, then Mivacurium	Drug: Atropine, Fentanyl, Mivacurium; Atropin 10µg/kg Fentanyl 2µg/kg, repeat max. two times Mivacurium 200µg/kg

Outcome Measures

Primary Outcome Measures

1. Change of cerebral tissue oxygen saturation during premedication and intubation [from 1 minute before first study drug until 10 minutes after end of procedure]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 44 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• newborn infant below 44 weeks postmenstrual age

• indication for elective or semi-elective endotracheal Intubation

• parental informed consent

Exclusion Criteria:

• emergency intubation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center	Ulm	Baden-Württemberg	Germany	89075

Sponsors and Collaborators

• University of Ulm

Investigators

• Principal Investigator: Manuel B Schmid, Dr. med., University of Ulm

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Manuel Schmid, Dr. med., University of Ulm
• ClinicalTrials.gov Identifier: NCT01427985
• Other Study ID Numbers: ULMNEONIRS02
• First Posted: Sep 2, 2011
• Last Update Posted: Apr 6, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Atropine; Fentanyl; Mivacurium

Study Results

No Results Posted as of Apr 6, 2016