NCT06538584 · University of Chicago
Dex +/- Caffeine Sedation in a Post-MRI Recovery in a Pediatric Population
What this 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.
View original scientific description
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.
Interventions
DRUG
Caffeine citrate 15mg/kg
Subjects will be randomized prior to surgery into one of the two study arms. One arm will receive 15mg/kg Caffeine citrate 15 minutes post surgery.
DRUG
0.9% Sodium Citrate
Subjects will be randomized prior to surgery into one of the two study arms. One arm will receive 0.9% Sodium Citrate/kg 15 minutes post surgery.
Primary outcome measures
Improve rate of wakefulness post surgery
Time frame: Up to 2 hours
Subject post-surgery wakefulness recovery with caffeine based on a modified Aldrete score
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 12, 2025 · Source of record for eligibility and locations