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Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation

Information source: University of Manitoba
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bradycardia; Hypoxemia

Intervention: atropine (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Manitoba

Official(s) and/or principal investigator(s):
Michael R Narvey, MD, Principal Investigator, Affiliation: University of Manitoba

Overall contact:
Michael R Narvey, MD, Phone: 2047872720, Email: mnarvey@hsc.mb.ca

Summary

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.

Clinical Details

Official title: Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

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

Secondary outcome:

Heart rate < 100 BPM

Oxygen saturation < 85%

Duration of intubation attempts

Number of intubation attempts

Lowest heart rate after premedication

Lowest oxygen saturation after premedication

Detailed description: We hypothesize that premedication for intubation with fentanyl and succinylcholine alone will maintain equal stability of heart rate and oxygen saturation without a prolongation of time to completion of intubation when compared to a protocol using atropine, fentanyl and succinylcholine. In order to answer this question we plan to undertake a prospective randomized double blinded control trial of use of atropine as an adjunct for elective intubation of infants less than 46 weeks postmenstrual age.

Eligibility

Minimum age: N/A. Maximum age: 2 Months. Gender(s): Both.

Criteria:

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

Locations and Contacts

Michael R Narvey, MD, Phone: 2047872720, Email: mnarvey@hsc.mb.ca

Health Sciences Centre, Winnipeg, Manitoba R3A1R9, Canada; Recruiting
Michael Narvey, MD, Phone: 2047872720, Email: mnarvey@hsc.mb.ca
Michael R Narvey, MD, Principal Investigator
Jehier Afifi, MD, Sub-Investigator
John Baier, MD, Sub-Investigator
Additional Information

Starting date: April 2012
Last updated: September 23, 2013

Page last updated: August 23, 2015

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