Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation

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.

Study Overview

• Status: Unknown
• Conditions: Bradycardia; Hypoxemia
• Intervention / Treatment: Drug: atropine; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Michael R Narvey, MD; Phone Number: 2047872720; Email: mnarvey@hsc.mb.ca
• Study Contact Backup: Name: Jehier Afifi, MD; Phone Number: 9024706944; Email: Jehier.afifi@iwk.nshealth.ca

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Atropine, fentanyl and succinylcholine; 20 mcg/kg atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.	Drug: atropine; Atropine 0.02 mg/kg IV; Other Names: AtroPen
Placebo Comparator: placebo, fentanyl and succinylcholine; an equivalent volume of normal saline to atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.	Drug: Placebo; an equivalent volume of normal saline to atropine IV; Other Names: 0.9% sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate less than 80 BPM and oxygen saturation less than 80%	Heart rate and transcutaneous oxygen saturation will be monitored continuously during the procedure and data will be recorded at 3 stages; 2 minutes prior to intubation (after atropine or placebo dose); during intubation; 2 minutes after intubation (once ETT secured to face)	5-6 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Heart rate < 100 BPM	5-6 minutes
Oxygen saturation < 85%	5-6 minutes
Duration of intubation attempts	1-2 minutes
Number of intubation attempts	5-6 minutes
Lowest heart rate after premedication	5-6 minutes
Lowest oxygen saturation after premedication	5-6 minutes

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Michael R Narvey, MD, University of Manitoba

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: May 8, 2012
• First Submitted That Met QC Criteria: May 8, 2012
• First Posted (Estimate): May 10, 2012

Study Record Updates

• Last Update Posted (Estimate): September 24, 2013
• Last Update Submitted That Met QC Criteria: September 23, 2013
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: intubation; premedication; bradycardia; hypoxemia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Arrhythmias, Cardiac; Bradycardia; Hypoxia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Atropine
• Other Study ID Numbers: R500458