NCT06538584 Dex +/- Caffeine Sedation in a Post-MRI Recovery in a Pediatric Population
| NCT ID | NCT06538584 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Chicago |
| Condition | Enhanced Recovery After Surgery in a Pediatric Population |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-09-09 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2024-09-09 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Zheng Xie, MD,PhD
PRINCIPAL INVESTIGATOR
University of Chicago
Frequently Asked Questions
Who can join the NCT06538584 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 12 Years, studying Enhanced Recovery After Surgery in a Pediatric Population. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06538584 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06538584 currently recruiting?
Yes, NCT06538584 is actively recruiting participants. Contact the research team at jxie@bsd.uchicago.edu for enrollment information.
Where is the NCT06538584 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06538584 clinical trial?
NCT06538584 is sponsored by University of Chicago. The principal investigator is Zheng Xie, MD,PhD at University of Chicago. The trial plans to enroll 100 participants.