Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Manitoba.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01595399
First received: May 8, 2012
Last updated: September 23, 2013
Last verified: May 2012
  Purpose

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
Bradycardia
Hypoxemia
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.

  Eligibility

Ages Eligible for Study:   up to 2 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595399

Contacts
Contact: Michael R Narvey, MD 2047872720 mnarvey@hsc.mb.ca
Contact: Jehier Afifi, MD 9024706944 Jehier.afifi@iwk.nshealth.ca

Locations
Canada, Manitoba
Health Sciences Centre Recruiting
Winnipeg, Manitoba, Canada, R3A1R9
Contact: Michael Narvey, MD    2047872720    mnarvey@hsc.mb.ca   
Principal Investigator: Michael R Narvey, MD         
Sub-Investigator: Jehier Afifi, MD         
Sub-Investigator: John Baier, MD         
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Michael R Narvey, MD University of Manitoba
  More Information

No publications provided

Responsible Party: University of Manitoba
ClinicalTrials.gov 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:
bradycardia
hypoxemia
intubation
premedication

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Atropine
Succinylcholine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Mydriatics
Neuromuscular Agents
Neuromuscular Blocking Agents
Neuromuscular Depolarizing Agents
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014