Phase 4 N=60 Other

Heart Rate Response to Atropine Doses Less Than 0.1mg IV to Anesthetized Infants

Bradycardia · Arrhythmias

Bottom Line

View on ClinicalTrials.gov: NCT01819064 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2023

Primary outcome: Primary: Incidence of Bradycardia — 0; 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Atropine (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: State University of New York at Buffalo
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Bradycardia	0; 0	—

Summary

An infants heart rate is very important because it ensures that blood is pumped to all organs in the body. Heart rate may decrease during anesthesia and surgery, and this is why the anesthesiologist will often give a medication to prevent this from happening. The most common drug for this purpose is called atropine. The dose of most drugs given to babies is based upon the baby's weight, but some believe that the dose of atropine should not be less than 0.1mg. However there is no evidence to support this minimum dose. A larger dose of atropine may cause a very fast heart rate instead. Anesthesiologists routinely dose the atropine based upon the baby's weight without regard for a minimum dose. The purpose of the present study is to measure the heart rate after doses of atropine in neonates and infants who receive less than 0.1 mg.

Eligibility Criteria

Inclusion Criteria

Age : 0-2 years old
Weight : less than the 95th percentile for age and height ( no more than 15kg )
ASA classification : I-II
Meets the hospital and department of anesthesiology guidelines with respect to peri-operative care

Exclusion Criteria

History of heart disease
Any condition predisposing to arrhythmia
Any medication known to influence the heart rate
Child taking anti-cholinergic medication routinely
The use of succinylcholine anticipated (will cause bradycardia)
Rapid sequence intubation is required (due to aspiration risk)
Known difficult airway (may be difficult to bag mask ventilate)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01819064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.