Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation

This study is currently recruiting participants.
Verified May 2012 by University of Manitoba
Information provided by (Responsible Party):
University of Manitoba Identifier:
First received: May 8, 2012
Last updated: September 23, 2013
Last verified: May 2012

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.

Condition Intervention Phase
Drug: atropine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation

Resource links provided by NLM:

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Heart rate less than 80 BPM and oxygen saturation less than 80% [ Time Frame: 5-6 minutes ] [ Designated as safety issue: Yes ]

    Heart rate and transcutaneous oxygen saturation will be monitored continuously during the procedure and data will be recorded at 3 stages;

    1. 2 minutes prior to intubation (after atropine or placebo dose)
    2. during intubation
    3. 2 minutes after intubation (once ETT secured to face)

Secondary Outcome Measures:
  • Heart rate < 100 BPM [ Time Frame: 5-6 minutes ] [ Designated as safety issue: Yes ]
  • Oxygen saturation < 85% [ Time Frame: 5-6 minutes ] [ Designated as safety issue: Yes ]
  • Duration of intubation attempts [ Time Frame: 1-2 minutes ] [ Designated as safety issue: Yes ]
  • Number of intubation attempts [ Time Frame: 5-6 minutes ] [ Designated as safety issue: Yes ]
  • Lowest heart rate after premedication [ Time Frame: 5-6 minutes ] [ Designated as safety issue: Yes ]
  • Lowest oxygen saturation after premedication [ Time Frame: 5-6 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: April 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 0.9% sodium chloride

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.


Ages Eligible for Study:   up to 2 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01595399

Contact: Michael R Narvey, MD 2047872720
Contact: Jehier Afifi, MD 9024706944

Canada, Manitoba
Health Sciences Centre Recruiting
Winnipeg, Manitoba, Canada, R3A1R9
Contact: Michael Narvey, MD    2047872720   
Principal Investigator: Michael R Narvey, MD         
Sub-Investigator: Jehier Afifi, MD         
Sub-Investigator: John Baier, MD         
Sponsors and Collaborators
University of Manitoba
Principal Investigator: Michael R Narvey, MD University of Manitoba
  More Information

No publications provided

Responsible Party: University of Manitoba Identifier: NCT01595399     History of Changes
Other Study ID Numbers: R500458
Study First Received: May 8, 2012
Last Updated: September 23, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neuromuscular Depolarizing Agents processed this record on April 17, 2014