Recruiting

Atropine vs. No Atropine

Sponsor:

University of Manitoba

Code:

NCT01595399

Conditions

Bradycardia

Hypoxemia

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

atropine

Placebo

Study Details

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.

Conditions

Bradycardia

Hypoxemia

Study ID

NCT01595399

Start date

Apr, 2012

Status verified date

May, 2012

Completion date

Jun, 2014

Anticipated

Primary completion date

Jun, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Atropine, fentanyl and succinylcholine

20 mcg/kg atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.

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.

Interventions

atropine

Atropine 0.02 mg/kg IV

Placebo

an equivalent volume of normal saline to atropine IV

Primary outcome measure

  • Heart rate less than 80 BPM and oxygen saturation less than 80% [ Time Frame: 5-6 minutes ]

Central Contacts and Locations

Central contacts

Michael R Narvey, MD

2047872720mnarvey@hsc.mb.ca

Jehier Afifi, MD

9024706944Jehier.afifi@iwk.nshealth.ca

Locations

Health Sciences Centre

Recruiting

Winnipeg, Manitoba, Canada, R3A1R9

Contacts

Michael Narvey, MD

2047872720mnarvey@hsc.mb.ca

Principal Investigator:

Michael R Narvey, MD

More Information

Sponsor

University of Manitoba

Last update posted

Sep 24, 2013

Last verified

May, 2012

Keywords

  • bradycardia
  • hypoxemia
  • intubation
  • premedication

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2013-09-24.