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Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01595399
Recruitment Status : Unknown
Verified May 2012 by University of Manitoba.
Recruitment status was:  Recruiting
First Posted : May 10, 2012
Last Update Posted : September 24, 2013
Information provided by (Responsible Party):
University of Manitoba

Brief 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.

Condition or disease Intervention/treatment Phase
Bradycardia Hypoxemia Drug: atropine Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation
Study Start Date : April 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

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 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

Primary Outcome Measures :
  1. Heart rate less than 80 BPM and oxygen saturation less than 80% [ Time Frame: 5-6 minutes ]

    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 :
  1. Heart rate < 100 BPM [ Time Frame: 5-6 minutes ]
  2. Oxygen saturation < 85% [ Time Frame: 5-6 minutes ]
  3. Duration of intubation attempts [ Time Frame: 1-2 minutes ]
  4. Number of intubation attempts [ Time Frame: 5-6 minutes ]
  5. Lowest heart rate after premedication [ Time Frame: 5-6 minutes ]
  6. Lowest oxygen saturation after premedication [ Time Frame: 5-6 minutes ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01595399

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

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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
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Principal Investigator: Michael R Narvey, MD University of Manitoba
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Responsible Party: University of Manitoba Identifier: NCT01595399    
Other Study ID Numbers: R500458
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: September 24, 2013
Last Verified: May 2012
Keywords provided by University of Manitoba:
Additional relevant MeSH terms:
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Signs and Symptoms, Respiratory
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Adjuvants, Anesthesia
Anti-Arrhythmia 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