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Dex +/- Caffeine Sedation in a Post-MRI Recovery in a Pediatric Population

RecruitingPhase 1, Phase 2Ages 3 Years - 12 YearsAllUniversity of Chicago
NCT06538584 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

Dexmedetomidine (Dex), a selective ฮฑ2-adrenergic receptor agonist, is the most used sedative for procedural sedation in children and in pediatric Intensive Care Unit (PICU) because it is associated with less respiratory depression and also less neurotoxicity; rather Dex appears neuroprotective. Unfortunately, Dex is associated with very long emergence times and may cause bradycardia and hypotension. However, using sedation dosing guidelines (by consensus among SPS members) 1-3 mcg/kg bolus and a 1-2 mcg/kg/hour infusion, hemodynamic compromise is less significant and rarely requires intervention in these patients. With this Dex sedation protocol, these pediatric patients usually take an average of 45 minutes (30-60 minutes) to wake and become alert and up to 2 hours to be discharged. Without reversal agents, emergence times from Dex sedation are slow. The prolonged recovery after Dex se

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Undergo Magnetic Resonance Imaging (MRI) scan * Age โ‰ฅ3 and โ‰ค 12 yr old * Both Male and Female * Weight โ‰ค33.3 kg * American Society of Anesthesiologists ASA) physical status 1-3 * No History of Arrhythmia (3-leads Electrocardiogram \[EKG\] applied before and after the sedation) or congenital heart disease * Capable of obtaining consent from at least one parent * No history of liver and kidney impairment * No history of head trauma * No prior history of difficulty with anesthesia * No personal or family history of malignant hyperthermia Exclusion Criteria: * Age \<3 or \>12 * Weight \>33.3 kg * ASA physical status \> 3 * History Arrhythmia, congenital heart disease, liver, and kidney diseases * Prior difficulty with anesthesia * Personal or family history of malignant hyperthermia * Unable to obtain consent * History of head trauma * Female subjects who are pregnant
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What it tests

  • Caffeine citrate 15mg/kg
  • 0.9% Sodium Citrate
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Where

1 site
University of Chicago Medical Center
Chicago, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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