Influence of Premedication Protocols for Neonatal Endotracheal Intubation on Cerebral Oxygenation

Phase 4

Completed

• Conditions: Intubation; Newborn; Preterm
• Interventions: Drug: Atropine, Fentanyl, Mivacurium

• Registration Number: NCT01427985
• Lead Sponsor: University of Ulm

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.

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-08-31
• Study First Submitted QC: 2011-09-01
• Study First Posted: 2011-09-02
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• newborn infant below 44 weeks postmenstrual age
• indication for elective or semi-elective endotracheal Intubation
• parental informed consent

Exclusion Criteria

• emergency intubation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Analgosedation followed by Relaxation	Atropine, Fentanyl, Mivacurium	Give atropin, then Fentanyl, then Mivacurium
Relaxation followed by analgosedation	Atropine, Fentanyl, Mivacurium	Give Atropin, then Mivacurium, immediately followed by Fentanyl

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Medical Center; 🇩🇪 Ulm, Baden-Württemberg, Germany