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NCT06538584 · ClinicalTrials.gov registry record · Phase 1
Dex +/- Caffeine Sedation in a Post-MRI Recovery in a Pediatric Population
A Phase 1 study of Enhanced Recovery After Surgery in a Pediatric Population, sponsored by University of Chicago.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06538584: Recruiting Phase 1 study of Enhanced Recovery After Surgery in a Pediatric Population, sponsored by University of Chicago.
NCT06538584 is a Phase 1 study of Enhanced Recovery After Surgery in a Pediatric Population that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06538584, a Phase 1 study of Enhanced Recovery After Surgery in a Pediatric Population, is actively recruiting participants, sponsored by University of Chicago.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Subject post-surgery wakefulness recovery with caffeine based on a modified Aldrete score
Conditions Studied
Interventions
- DRUG Caffeine citrate 15mg/kg
- DRUG 0.9% Sodium Citrate
Study Locations (1)
Illinois
- University of Chicago Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-09-09 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT06538584 shows while recruiting
NCT06538584 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
The record links to 1 condition, with Enhanced Recovery After Surgery in a Pediatric Population appearing as the primary indexed condition, and to 2 interventions - of which Caffeine citrate 15mg/kg is the first listed.
NCT06538584 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06538584 about?
NCT06538584 is a clinical study titled "Dex +/- Caffeine Sedation in a Post-MRI Recovery in a Pediatric Population". 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. Unfo...
What is the current status of trial NCT06538584?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2024-09-09. Estimated completion is 2027-12-31.
What conditions does trial NCT06538584 study?
This clinical trial studies the following conditions: Enhanced Recovery After Surgery in a Pediatric Population.
What interventions are being tested in trial NCT06538584?
The interventions under investigation include: Caffeine citrate 15mg/kg (DRUG), 0.9% Sodium Citrate (DRUG).
Who is sponsoring clinical trial NCT06538584?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06538584 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06538584's enrollment target sits among peer trials
100 546th of 2000 higher than 1,411 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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