Dex +/- Caffeine Sedation in a Post-MRI Recovery in a Pediatric Population
University of Chicago · NCT06538584
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 3–12 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 1, Phase 2
- Target enrollment
- 100
- US sites recruiting
- 1
- Study start
- September 9, 2024
- Record last updated
- September 12, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: Caffeine citrate 15mg/kg; 0.9% Sodium Citrate
Conditions: Enhanced Recovery After Surgery in a Pediatric Population
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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
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
Recruiting US locations
University of Chicago Medical Center
Chicago, IL 60637
Site contact: Zheng (Jimmy) Xie, MD, PhD · 773-702-2667 · JXie@dacc.uchicago.edu
Study contacts (from the official record)
- Zheng Xie, MD, PhD · 773-702-2667 · jxie@bsd.uchicago.edu
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