Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation
- Registration Number
- NCT01595399
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- Any infant (preterm and term) up to 46 weeks corrected age requiring (nonemergent) intubation.
- IV access is obtained
- Informed parental consent
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atropine, fentanyl and succinylcholine atropine 20 mcg/kg atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV. placebo, fentanyl and succinylcholine Placebo an equivalent volume of normal saline to atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.
- Primary Outcome Measures
Name Time Method Heart rate less than 80 BPM and oxygen saturation less than 80% 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
Name Time Method 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 Heart rate < 100 BPM 5-6 minutes Oxygen saturation < 85% 5-6 minutes
Trial Locations
- Locations (1)
Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada