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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jerrold Lerman, State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT01819064
First received: February 4, 2013
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Bradycardia
Arrhythmias
Drug: Atropine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Do Small Doses of Atropine Cause Bradycardia in Young Children

Resource links provided by NLM:


Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:
  • Incidence of Bradycardia [ Time Frame: five minutes ] [ Designated as safety issue: Yes ]
    Incidence of bradycardia during the first 5 minutes after atropine


Enrollment: 60
Study Start Date: February 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Children less than 5Kg.
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 5Kg will receive atropine 5 mcg/kg IV during sevoflurane anesthesia.
Drug: Atropine
intravenous atropine in low doses does not cause bradycardia
Other Names:
  • atropine sulfate
  • atropine injection
Drug: Atropine
IV dose at 5 mcg/kg
Other Names:
  • atropine sulfate
  • atropine injection
Children weighing 5Kg to 15Kg
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 between 5Kg and 15Kg will receive atropine 5 mcg/kg IV during sevoflurane anesthesia.
Drug: Atropine
intravenous atropine in low doses does not cause bradycardia
Other Names:
  • atropine sulfate
  • atropine injection
Drug: Atropine
IV dose at 5 mcg/kg
Other Names:
  • atropine sulfate
  • atropine injection

Detailed Description:

60 neonates and 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.

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children less than 2 yrs of age, weighing less than 15Kg coming to Women and Children's hospital of Buffalo for elective surgery.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. History of heart disease
  2. Any condition predisposing to arrhythmia
  3. Any medication known to influence the heart rate
  4. Child taking anti-cholinergic medication routinely
  5. The use of succinylcholine anticipated (will cause bradycardia)
  6. Rapid sequence intubation is required (due to aspiration risk)
  7. Known difficult airway (may be difficult to bag mask ventilate)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819064

Locations
United States, New York
Women and Children's Hospital of Buffalo
Buffalo, New York, United States, 14222
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
Principal Investigator: Jerrold Lerman, MD FRCPC SUNY at Buffalo, Women and Children's Hospital of Buffalo
  More Information

No publications provided

Responsible Party: Jerrold Lerman, Clinical Professor of Anesthesiology, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT01819064     History of Changes
Other Study ID Numbers: Atropine in infants
Study First Received: February 4, 2013
Last Updated: August 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York at Buffalo:
Atropine
bradycardia
tachycardia

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Bradycardia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Atropine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014