Heart Rate Response to Atropine Doses Less Than 0.1mg IV to Anesthetized Infants
Primary Purpose
Bradycardia, Arrhythmias
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atropine
Sponsored by
About this trial
This is an interventional other trial for Bradycardia focused on measuring Atropine, bradycardia, tachycardia
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)
Sites / Locations
- Women and Children's Hospital of Buffalo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Infants and children less than 15Kg.
Arm Description
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.
Outcomes
Primary Outcome Measures
Incidence of Bradycardia
incidence of bradycardia or other arrhythmias
Secondary Outcome Measures
Full Information
NCT ID
NCT01819064
First Posted
February 4, 2013
Last Updated
April 5, 2023
Sponsor
State University of New York at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT01819064
Brief Title
Heart Rate Response to Atropine Doses Less Than 0.1mg IV to Anesthetized Infants
Official Title
Do Small Doses of Atropine Cause Bradycardia in Young Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
60 infants, ASA physical status I and II, undergoing elective surgical procedures will be enrolled after signed informed parental consent.
All children will be fasted according to institutional guidelines and unpremedicated. After arriving in the operating room, EKG, pulse oximeter and blood pressure monitors will be applied (Datex-Ohmeda Aisys).
Anesthesia will be induced with 66% N2O in O2 and 8% sevoflurane. Respiration will be supported by a properly sized face mask through which he/she is allowed to breath spontaneously. Respiration will continue spontaneously through a facemask at 2 MAC sevoflurane in 66% N2O.
All children will be positioned supine, warmed with a forced air warmer and given 20 ml/kg IV balanced salt solution over 30 minutes after the IV has been established. The end-tidal pCO2 will maintained 35-45 mmHg and oxygen saturation >96%.
After a 22 or 24G IV cannula is inserted, 0.005 mg/kg atropine will be administered intravenously over 5 seconds through a fast-flowing IV and followed by 5 ml of normal saline to flush it in through the IV deadspace. The study (ECG recording) period will extend from 30 seconds before atropine administration to 5 minutes after injection. During this time the heart rate and rhythm (through lead II) will be monitored and recorded continuously using an analogue interface system. EKG will be recorded on paper continuously for the 330 seconds of the study.
The recording will be analyzed for the heart rate (based on the R-R interval) and arrhythmias by a physician blinded to the study. Blinding means that the individual is unaware of the hypothesis of the study and what medication was administered to account for any changes in heart rate. Bradycardia is defined as a 20% reduction from baseline heart rate while tachycardia is a heart rate > 160 beats/minute(6). Any heart rate < 100/minute will be considered a bradycardia in this age group. Arrhythmia is any disorder of rhythm or rate observed. These will be summarized for each child.
All heart rate responses will be recorded and reviewed. The time to record the heart rate after atropine, which will occur before surgery, will add less than 5 additional minutes to the anesthetic since it will overlap the time taken for other surgical preparatory events.
The blood pressure will be monitored non-invasively immediately before receiving atropine and at one and five minutes after it is given.
The primary outcome is the incidence of bradycardia during the first 5 minutes after atropine will be determined by reviewing the electrocardiogram. All continuous data will be reported as means +/- standard deviation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Arrhythmias
Keywords
Atropine, bradycardia, tachycardia
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
This is a single arm study where a dose of atropine was administered and the ECG recorded.
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Infants and children less than 15Kg.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atropine
Other Intervention Name(s)
atropine sulfate, atropine injection
Intervention Description
intravenous atropine affect on heart rate
Primary Outcome Measure Information:
Title
Incidence of Bradycardia
Description
incidence of bradycardia or other arrhythmias
Time Frame
five minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerrold Lerman, MD FRCPC
Organizational Affiliation
SUNY at Buffalo, Women and Children's Hospital of Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women and Children's Hospital of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25762533
Citation
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.
Results Reference
derived
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Heart Rate Response to Atropine Doses Less Than 0.1mg IV to Anesthetized Infants
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