A Pilot Study of Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot study to determine if a standard bolus dose and infusion of dexmedetomidine can significantly decrease the dose of propofol (infusion) required for accomplishing an MRI. The investigators are adding a second arm to this study to examine the effectiveness of dexmedetomidine (single) bolus dose (with no infusion) followed by propofol infusion to accomplish MRI.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joseph Cravero; Joseph P. Cravero
• Treatments: Dexmedetomidine; Propofol

Criteria

Inclusion Criteria:

1. Subjects presenting as out-patients, scheduled to receive an anesthetic for MRI of body (spine, chest, abdomen, and/or pelvis) and/or extremity (arm and/or leg).

2. The subject must be a candidate for the sedation technique described in this study with a natural airway (see exclusion criteria described below). This decision will be made by a staff member of the Department of Anesthesiology.

3. The subjects must be 1 and 12 years.

4. The subject's legally authorized representative has given written informed consent to participate in the study.

5. American Society of Anesthesiologist status I, II, or III

Exclusion Criteria:

1. The subject is residing in the Pediatric Intensive Care Unit, the Cardiac Intensive Care Unit, or Neonatal Intensive Care Unit.

2. Diagnosis of a difficult airway or severe obstructive sleep apnea that is not compatible with spontaneous ventilation in a supine position.

3. Congenital heart disease or history of dysrhythmia.

4. Patient taking digoxin or beta-blocker

5. Anxiolytic medication is ordered before the MRI (e.g., midazolam or ketamine).

6. The subject has a history or a family (parent or sibling) history of malignant hyperthermia.

7. The subject is allergic to or has a contraindication to propofol or dexmedetomidine.

8. The subject has previously been treated under this protocol.

9. The subject has a tracheostomy or other mechanical airway device.

10. The subject has received within the past 12 hours an oral or intravenous alpha-adrenergic, beta-adrenergic agonist, or antagonist drugs (e.g., clonidine, propranolol, albuterol).

11. The subject is not scheduled to receive anesthesia-sedation care for the MRI.

12. The subject received one of the anesthetic regimens for the same MRI during the past six months.