Actively Recruiting
Dex +/- Caffeine Sedation in a Post-MRI Recovery in a Pediatric Population
Led by University of Chicago · Updated on 2025-09-12
100
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dex +/- Caffeine Sedation in a Post-MRI Recovery in a Pediatric Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergo Magnetic Resonance Imaging (MRI) scan
- Age 3 years to 12 years old
- Male or Female
- Weight less than or equal to 33.3 kg
- American Society of Anesthesiologists (ASA) physical status 1 to 3
- No history of arrhythmia or congenital heart disease
- Consent obtained from at least one parent
- No history of liver or kidney impairment
- No history of head trauma
- No prior difficulty with anesthesia
- No personal or family history of malignant hyperthermia
You will not qualify if you...
- Age less than 3 years or greater than 12 years
- Weight greater than 33.3 kg
- ASA physical status greater than 3
- History of arrhythmia, congenital heart disease, liver, or 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
Z
Zheng Xie, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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