Influence of Premedication Protocols for Neonatal Endotracheal Intubation on Cerebral Oxygenation

University of Ulm

Status and phase: Completed; Phase 4

Conditions: Preterm; Newborn; Intubation

Treatments: Drug: Atropine, Fentanyl, Mivacurium

Study type: Interventional

Funder types: Other

Identifiers

NCT01427985

ULMNEONIRS02

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 24 patients

Sex: All

Ages: Under 44 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• emergency intubation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

Relaxation followed by analgosedation

Experimental group

Description:

Give Atropin, then Mivacurium, immediately followed by Fentanyl

Treatment:

Drug: Atropine, Fentanyl, Mivacurium

Drug: Atropine, Fentanyl, Mivacurium

Analgosedation followed by Relaxation

Active Comparator group

Description:

Give atropin, then Fentanyl, then Mivacurium

Treatment:

Drug: Atropine, Fentanyl, Mivacurium

Drug: Atropine, Fentanyl, Mivacurium