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

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Enhanced Recovery After Surgery in a Pediatric Population

In brief

Dexmedetomidine (Dex), a selective α2-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 sedation for non-surgical procedures negatively affects throughput, thus increasing the cost of care. Patient safety and satisfaction suffer as a result. The children wake feeling tired and sluggish. The children don't feel back to normal for an extended period of time, which is not surprising given that the half-life for Dex metabolism in 2-3 hours in humans. 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. In humans, it has been found that caffeine at 7.5 mg/kg (15 mg caffeine citrate equivalent to 7.5 mg caffeine base) sped emergence from isoflurane anesthesia with minimal hemodynamic effects in healthy human volunteers. The goal of this clinical trial is to determine whether caffeine will facilitate the recovery of Dex sedation after a Magnetic Resonance Imaging (MRI) procedure by measuring the time from the end of Dex infusion to the time meeting the discharge criteria.

Key facts

Study ID: NCT06538584
Run by: University of Chicago
People needed: 100
Starts: 2024-09-09
Expected to finish: 2027-12-31
Last updated by the study team: 2025-09-12

Who can join

Age: 3 and older, up to 12. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Undergo Magnetic Resonance Imaging (MRI) scan
Age ≥3 and ≤ 12 yr old
Both Male and Female
Weight ≤33.3 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

You may not qualify if…

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

Where it is running

University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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