Phase 4
N=71
A Pilot Study of Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging
Epilepsy · Cerebral Palsy · Developmental Delay
Bottom Line
View on ClinicalTrials.gov: NCT02633241 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Dosage/Consumption — 0.36; 0.25 mcg/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexmedetomidine bolus and high infusion-Propofol (Drug); Dexmedetomidine bolus and low infusion-Propofol (Drug); Dexmedetomidine bolus only - Propofol (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Joseph Cravero
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dosage/Consumption |
0.36; 0.25 | — |
| PRIMARY Incidence of Patient Movement and MRI Interruption |
2; 3; 2 | — |
| PRIMARY Incidence of Adverse Events |
1; 1; 3 | — |
| PRIMARY Case Times |
7; 7; 7 | — |
| SECONDARY Incidence of Technique Failure |
0; 0; 0 | — |
| SECONDARY Sedation Infusion Time |
43; 50 | — |
| SECONDARY Case Duration |
52.8; 53.3; 40.1 | — |
| SECONDARY Recovery Time |
63.5; 60.9; 42.5 | — |
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 studied three arms to examine the effectiveness of dexmedetomidine. Arm 1 was a single bolus of 1.0 mcg/kg with 1.0 mcg/kg/hr infusion followed by propofol infusion. Arm 2 was a bolus of 1.0 mcg/kg with 0.5 mcg/kg/hr infusion followed by propofol infusion. Arm 3 was only a single bolus of 1.0 mcg/kg with no infusion followed by propofol infusion.
Eligibility Criteria
Inclusion Criteria
- 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).
- 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.
- The subjects must be 1 and 12 years.
- The subject's legally authorized representative has given written informed consent to participate in the study.
- American Society of Anesthesiologist status I, II, or III
Exclusion Criteria
- The subject is residing in the Pediatric Intensive Care Unit, the Cardiac Intensive Care Unit, or Neonatal Intensive Care Unit.
- Diagnosis of a difficult airway or severe obstructive sleep apnea that is not compatible with spontaneous ventilation in a supine position.
- Congenital heart disease or history of dysrhythmia.
- Patient taking digoxin or beta-blocker
- Anxiolytic medication is ordered before the MRI (e.g., midazolam or ketamine).
- The subject has a history or a family (parent or sibling) history of malignant hyperthermia.
- The subject is allergic to or has a contraindication to propofol or dexmedetomidine.
- The subject has previously been treated under this protocol.
- The subject has a tracheostomy or other mechanical airway device.
- 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).
- The subject is not scheduled to receive anesthesia-sedation care for the MRI.
- The subject received one of the anesthetic regimens for the same MRI during the past six months.
Data sourced from ClinicalTrials.gov (NCT02633241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.