Evaluating the Effects of Propofol vs. Dexmedetomidine (NCT03552146) | Clinical Trial Compass
UnknownNot Applicable
Evaluating the Effects of Propofol vs. Dexmedetomidine
United States60 participantsStarted 2018-07-24
Plain-language summary
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.)
Who can participate
Age range3 Months – 36 Months
SexALL
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Inclusion criteria
✓. Patient (or Parent/Guardian) is English speaking
✓. Patient is undergoing a scheduled, elective non-contrast MRI of the brain
✓. Patient is \> 3 months to \<36 months of age
Exclusion criteria
✕. Patients undergoing MRI with contrast
✕. Patients older than 36 months of age or younger than 3 months of age
✕. Patients presenting to Emergency Department (ED) out of screening hours
✕. Patients who are not English speaking
✕. Patients who have history or record of propofol or dexmedetomidine allergy
✕. 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.
What they're measuring
1
Procedural times to achieve optimal sedation
Timeframe: Start of procedure to discharge (up to 8 hours)