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NCT01819064 · ClinicalTrials.gov registry record · Phase 4
Heart Rate Response to Atropine Doses Less Than 0.1mg IV to Anesthetized Infants
A Phase 4 study, sponsored by State University of New York at Buffalo.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT01819064: Completed Phase 4 study, sponsored by State University of New York at Buffalo.
NCT01819064 is a Phase 4 study that has completed, run by State University of New York at Buffalo. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01819064, a Phase 4 study, has completed, sponsored by State University of New York at Buffalo.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
incidence of bradycardia or other arrhythmias
Interventions
- DRUG Atropine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2013-02 |
| Est. Completion | 2013-07 |
| Phase | Phase 4 |
What the finished NCT01819064 record still lists
NCT01819064 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Atropine is the first listed.
NCT01819064 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01819064 about?
NCT01819064 is a clinical study titled "Heart Rate Response to Atropine Doses Less Than 0.1mg IV to Anesthetized Infants". 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...
What is the current status of trial NCT01819064?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2013-02. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01819064?
The interventions under investigation include: Atropine (DRUG).
Who is sponsoring clinical trial NCT01819064?
This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01819064's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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