Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation
|ClinicalTrials.gov 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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Active Comparator: Atropine, fentanyl and succinylcholine
20 mcg/kg atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.
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.
an equivalent volume of normal saline to atropine IV
Other Name: 0.9% sodium chloride
- 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;
- 2 minutes prior to intubation (after atropine or placebo dose)
- during intubation
- 2 minutes after intubation (once ETT secured to face)
- Heart rate < 100 BPM [ Time Frame: 5-6 minutes ]
- Oxygen saturation < 85% [ Time Frame: 5-6 minutes ]
- Duration of intubation attempts [ Time Frame: 1-2 minutes ]
- Number of intubation attempts [ Time Frame: 5-6 minutes ]
- Lowest heart rate after premedication [ Time Frame: 5-6 minutes ]
- Lowest oxygen saturation after premedication [ Time Frame: 5-6 minutes ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595399
|Contact: Michael R Narvey, MDemail@example.com|
|Contact: Jehier Afifi, MD||9024706944||Jehier.firstname.lastname@example.org|
|Health Sciences Centre||Recruiting|
|Winnipeg, Manitoba, Canada, R3A1R9|
|Contact: Michael Narvey, MD 2047872720 email@example.com|
|Principal Investigator: Michael R Narvey, MD|
|Sub-Investigator: Jehier Afifi, MD|
|Sub-Investigator: John Baier, MD|
|Principal Investigator:||Michael R Narvey, MD||University of Manitoba|