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Bradycardia | Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation

Bradycardia research study

What is the primary objective of this study?

The purpose of this study is to compare heart rate in infants who receive atropine as a part of their medication before intubation to those who do not. To be able to find out , we need to divided babies into 2 groups; group 1 : receives atropine + sedation + muscle relaxant group 2 : receives water or saline ( placebo group) + sedation + muscle relaxant Then we need to compare heart rate during intubation and duration of intubation between the 2 groups.

Who is eligible to participate?

Inclusion Criteria: - Any infant (preterm and term) up to 46 weeks corrected age requiring (nonemergent) intubation. - IV access is obtained - Informed parental consent Exclusion Criteria: - Emergent intubation or need for resuscitation - Congenital cyanotic heart disease - Obvious airway abnormalities - History of myopathy or family history of malignant hyperthermia or known history of phosphocholinesterase deficiency

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Bradycardia

Hypoxemia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:atropineAtropine 0.02 mg/kg IV

Drug:Placeboan equivalent volume of normal saline to atropine IV

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Atropine, fentanyl and succinylcholine20 mcg/kg atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.

placebo, fentanyl and succinylcholinean equivalent volume of normal saline to atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.

Study Status

Unknown status

Start Date: April 2012

Completed Date: June 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Heart rate less than 80 BPM and oxygen saturation less than 80%

Secondary Outcome: Heart rate < 100 BPM

Study sponsors, principal investigator, and references

Principal Investigator: Michael R Narvey, MD

Lead Sponsor: University of Manitoba

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01595399

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