Evaluating the Effects of Propofol vs. Dexmedetomidine



Status:Recruiting
Healthy:No
Age Range:Any
Updated:7/27/2018
Start Date:July 24, 2018
End Date:March 31, 2019
Contact:David Fagin, MD
Email:david.fagin@pema.com
Phone:404-785-6000

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Evaluation of the Effects on Efficiency of a Sedation Service by Switching From Propofol to Dexmedetomidine

The primary purpose of this observational study is to compare what drugs work best in
sedating children (> 3 months to < 36 months) who need an MRI. This type of research may help
clinicians (healthcare providers) learn more about how dexmedetomidine works compared to
propofol. The investigators are planning to have 60 children complete the study at Children's
Healthcare of Atlanta at Scottish Rite. Half (30) of the patients will be randomized to
receive dexmedetomidine and the other half will receive propofol. (Both drugs are licensed
and approved for the sedation performed for consented patients.)

There are several different medications commonly being used to facilitate the administration
of radiologic procedures on children. Procedures such as Magnetic Resonance Imaging (MRIs)
require that the patient remain still for the duration of the test. Propofol has become the
drug of choice for many sedation services due to its rapid onset of action, rapid recovery
time, ability to achieve sedation reliably and favorable safety profile. Dexmedetomidine, a
selective alpha-2- adrenergic agonist, has also gained popularity with sedation services. Its
main advantage over propofol is that it has minimal respiratory complications when compared
to propofol. The sedative effect from dexmedetomidine preserves a natural sleep pattern and
induces cooperative sedation in which patients are easily arousable. In pediatric studies,
the most frequent adverse effect have been related to its potential to cause hypotension and
bradycardia, which resolve with dose reduction. Additionally, dexmedetomidine does not seem
to have as much impairment of cognitive function and has an opioid sparing effect.
Dexmedetomidine, however, has a longer onset of action and longer recovery time compared to
propofol, which has limited its use with many sedation services.

Inclusion Criteria:

1. Patient (or Parent/Guardian) is English speaking

2. Patient is undergoing a scheduled, elective non-contrast MRI of the brain

3. Patient is > 3 months to <36 months of age

Exclusion Criteria:

1. Patients undergoing MRI with contrast

2. Patients older than 36 months of age or younger than 3 months of age

3. Patients presenting to Emergency Department (ED) out of screening hours

4. Patients who are not English speaking

5. Patients who have history or record of propofol or dexmedetomidine allergy

6. Patients with known or history of anaphylaxis to eggs, egg products, soybeans, or soy
based products; if patient has a history of a hypersensitivity reaction associated
with exposure to eggs, egg products, soybeans, or soy based products, approval must be
given by the treating attending physician and documented on the patient's medical
record.

7. Patients with unstable cardiac or respiratory status as determined by treating
attending physician

8. Patients who are receiving digoxin
We found this trial at
1
site
1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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