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

NCT01819064 | Completed Phase 4 Results

• 1 other identifier: Atropine in infants
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bradycardia; Arrhythmias

Keywords

Atropine; bradycardia; tachycardia

Outcome Measures

Primary Outcomes (1)

• Incidence of Bradycardia

  incidence of bradycardia or other arrhythmias

  five minutes

Study Arms (1)

Infants and children less than 15Kg.

EXPERIMENTAL

This group consists of children who are ASA physical status I and II, less than 2 years of age and scheduled for elective surgical procedure and weigh less than 15Kg will receive atropine 5 mcg/kg IV during sevoflurane anesthesia.

Drug: Atropine

Interventions

Atropine DRUG

intravenous atropine affect on heart rate

Also known as: atropine sulfate, atropine injection

Infants and children less than 15Kg.

Eligibility Criteria

• Age: 1 Day - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Women and Children's Hospital of Buffalo

Buffalo, New York, 14222, United States

Location

Related Publications (1)

• Eisa L, Passi Y, Lerman J, Raczka M, Heard C. Do small doses of atropine (<0.1 mg) cause bradycardia in young children? Arch Dis Child. 2015 Jul;100(7):684-8. doi: 10.1136/archdischild-2014-307868. Epub 2015 Mar 11.

  PMID: 25762533 DERIVED

MeSH Terms

Conditions

Bradycardia; Arrhythmias, Cardiac; Tachycardia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Dr. Jerrold Lerman
• Organization: Women and Children's Hospital of Buffalo, State University of New York at Buffalo

jlerman@buffalo.edu

7168787701

Study Officials

• Jerrold Lerman, MD FRCPC

  SUNY at Buffalo, Women and Children's Hospital of Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Observer of ECG rhythm strips was unaware of the study hypothesis, the study drug administered, the dose given and the arrhythmias sought. Your statement that masking a single outcome implies a multi-arm study precludes a panoramic perspective of clinical research study designs and scenarios in which assessors may be effectively blinded.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Anesthesiology

Model Details: This is a single arm study where a dose of atropine was administered and the ECG recorded.

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: March 27, 2013
• Study Start: February 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 6, 2023
• Results First Posted: March 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)