BradycardiaPhase 4NCT01819064
Heart Rate Response to Atropine Doses Less Than 0.1mg IV to Anesthetized Infants
A Phase 4 study testing Atropine in people with Bradycardia and Arrhythmias, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 2 years
- Conditions the study is for
- Bradycardia, Arrhythmias
- What is being tested?
- Atropine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jul 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Women and Children's Hospital of Buffalo
Buffalo, New York, 14222
About this study
Official title: Do Small Doses of Atropine Cause Bradycardia in Young Children
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.
Read the 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.
- Conditions
- Bradycardia, Arrhythmias
- Being tested
- Atropine
- Keywords
- Atropine, bradycardia, tachycardia
- Medical subject headings
- Bradycardia, Arrhythmias, Cardiac, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtropineDrug
Also called atropine sulfate, atropine injection
intravenous atropine affect on heart rate
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Bradycardia
incidence of bradycardia or other arrhythmias
Measured: five minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm study where a dose of atropine was administered and the ECG recorded.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerrold Lerman, State University of New York at Buffalo
- Investigators
- Jerrold Lerman, MD FRCPC, Principal investigator, SUNY at Buffalo, Women and Children's Hospital of Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819064
- Sponsor's protocol ID
- Atropine in infants
- Status last verified
- Apr 2023
- First submitted
- 4 Feb 2013
- Last updated
- 6 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25762533
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Small Doses of Atropine Cause Bradycardia in Young Children
- ClinicalTrials.gov ID
- NCT01819064
- Acronym / sponsor ID
- Atropine in infants
- Conditions
- Bradycardia, Arrhythmias
- Keywords
- Atropine, bradycardia, tachycardia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Posted 28 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm study where a dose of atropine was administered and the ECG recorded.
| Arm | Type | Receives |
|---|---|---|
| Infants and children less than 15Kg. | Experimental | Drug: AtropineThis 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. |
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtropineAlso: atropine sulfate, atropine injectionintravenous atropine affect on heart rate | Drug | Infants and children less than 15Kg. |
Primary outcome
Incidence of Bradycardia
Time frame: five minutes
incidence of bradycardia or other arrhythmias
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25762533Eisa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerrold Lerman, MD FRCPC principal investigator
SUNY at Buffalo, Women and Children's Hospital of Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atropine in people with Bradycardia and Arrhythmias, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Bradycardia (time frame: five minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01819064, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.