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Propofol-Only Versus Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Notable Lead sponsor: Boston Children's Hospital to Boston Children's Hospital Show 7 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Start date changed from estimate of Jun 2026 to Jun 30, 2026
    • Interventions: Dexmedetomidine (IV) 0.5 mcg/kg (Drug), Dexmedetomidine (IV) 1 mcg/kg (Drug), Propofol (IV) 1-2 mg/kg (Drug), Propofol (IV) 2-4 mg/kg… to Dexmedetomidine (IV) 0.5 mcg/kg (Drug), Dexmedetomidine (IV) 1 mcg/kg (Drug), Propofol (IV) 1-2 mg/kg (Drug), Propofol (IV) 2-4 mg/kg…
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 3 of 7 entries
    • Site details revised
    • Publications: details revised at 7 of 7 entries
  2. Notable Recruitment openedv2 Show 4 more changesShow less
    • Start date: Feb 2026 to Jun 2026
    • Secondary endpoints: 6 to 7
    • Site details revised
    • Eligibility criteria expanded, about 1 word
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The most common imaging procedure requiring sedation/anesthesia for the pediatric population is magnetic resonance imaging (MRI). However, the optimal anesthetic/sedation plan has not been determined for these procedures. Historically, common medications have included the use of pentobarbital and propofol, but in 2015, publication in the New England Journal of Medicine highlighted the accumulating evidence for the possible neurotoxic effects of these types of anesthetics in animal models and a collection of epidemiologic studies in humans. Although these initial possibilities have since been proven as less of a concern, in the interim, data has shown that alternative sedative agents, such as dexmedetomidine, may not have the same neurotoxic effect and could possibly even provide neuroprotection. Dexmedetomidine also possesses other beneficial traits such as reducing risks of pulmonary atelectasis or upper airway collapse, typically found with the administration of propofol. A concern raised by previous studies has been the possibility that the addition of dexmedetomidine could increase recovery times, leading to disruptions in workflow. Although it has been shown that large doses of dexmedetomidine exposure may lead to longer PACU stays, it is uncertain whether a small dose of dexmedetomidine would have such a significant impact. Based on the investigators' pilot trial6, the investigators found that a bolus of 1 mcg/kg dose of dexmedetomidine with a bolus of titrated propofol of 2-3 mg/kg and an infusion of propofol of 100 mcg/kg/min provided adequate sedation for successful scans, reduced propofol (infusion) exposure by 60%, and did not significantly increase recovery times. Finally, there is a paucity in literature for studies examining a range of doses subsequently; often, a control group is compared to a single, self-selected dose of choice. Here, the investigators hope to provide a range of doses to minimize selection bias in our study design and determine the dose that would provide the optimal sedation for these scans and minimize excess anesthetic exposure.
Trial Details
NCT Number NCT07369128
Lead Sponsor Boston Children's Hospital
Conditions
(from sponsor)
MRI Sedation, Pediatric Sedation, Propofol Dosage, Emergence Delirium, Anesthesia, Recovery Time, Dexmedetomidine
Related terms Emergence Delirium
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov