Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07369128 · ClinicalTrials.gov registry record · Phase 4
Propofol-Only Versus Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging
A Phase 4 study, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 105
- Enrollment target
NCT07369128: Recruiting Phase 4 study, sponsored by Boston Children's Hospital.
NCT07369128 is a Phase 4 study that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 105 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07369128, a Phase 4 study, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 105 participants
- Enrollment target
Study Summary
The most common imaging procedure requiring sedation/anesthesia for the pediatric population is magnetic resonance imaging (MRI). However, the optimal anesthetic/sedation plan has not been determined for these procedures. Historically, common medications have included the use of pentobarbital and propofol, but in 2015, publication in the New England Journal of Medicine highlighted the accumulating evidence for the possible neurotoxic effects of these types of anesthetics in animal models and a collection of epidemiologic studies in humans. Although these initial possibilities have since been proven as less of a concern, in the interim, data has shown that alternative sedative agents, such as dexmedetomidine, may not have the same neurotoxic effect and could possibly even provide neuroprotection. Dexmedetomidine also possesses other beneficial traits such as reducing risks of pulmonary atelectasis or upper airway collapse, typically found with the administration of propofol. A concern raised by previous studies has been the possibility that the addition of dexmedetomidine could increase recovery times, leading to disruptions in workflow. Although it has been shown that large doses of dexmedetomidine exposure may lead to longer PACU stays, it is uncertain whether a small dose of dexmedetomidine would have such a significant impact. Based on the investigators' pilot trial6, the investigators found that a bolus of 1 mcg/kg dose of dexmedetomidine with a bolus of titrated propofol of 2-3 mg/kg and an infusion of propofol of 100 mcg/kg/min provided adequate sedation for successful scans, reduced propofol (infusion) exposure by 60%, and did not significantly increase recovery times. Finally, there is a paucity in literature for studies examining a range of doses subsequently; often, a control group is compared to a single, self-selected dose of choice. Here, the investigators hope to provide a range of doses to minimize selection bias in our study design and determine th
Primary Outcome
The total amount of propofol (mcg/kg/min) consumed will be measured for the duration of anesthesia time for the P, DLP, and DHP arms.
Interventions
- DRUG Dexmedetomidine (IV) 0.5 mcg/kg
- DRUG Propofol (IV) 2-4 mg/kg
- DRUG Dexmedetomidine (IV) 1 mcg/kg
- DRUG Propofol (IV) 1-2 mg/kg
- DRUG Propofol (IV) Infusion 250 mcg/kg/min
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2026-06 |
| Est. Completion | 2028-03 |
| Phase | Phase 4 |
What NCT07369128 shows while recruiting
NCT07369128 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 5 interventions - of which Dexmedetomidine (IV) 0.5 mcg/kg is the first listed.
NCT07369128 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07369128 about?
NCT07369128 is a clinical study titled "Propofol-Only Versus Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging". The most common imaging procedure requiring sedation/anesthesia for the pediatric population is magnetic resonance imaging (MRI). However, the optimal anesthetic/sedation plan has not been determined for these procedures. Historically, common medications have included the use of pentobarbital and pr...
What is the current status of trial NCT07369128?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 105 participants. The study started on 2026-06. Estimated completion is 2028-03.
What interventions are being tested in trial NCT07369128?
The interventions under investigation include: Dexmedetomidine (IV) 0.5 mcg/kg (DRUG), Propofol (IV) 2-4 mg/kg (DRUG), Dexmedetomidine (IV) 1 mcg/kg (DRUG), Propofol (IV) 1-2 mg/kg (DRUG), Propofol (IV) Infusion 250 mcg/kg/min (DRUG).
Who is sponsoring clinical trial NCT07369128?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07369128's enrollment target sits among peer trials
105 749th of 2000 higher than 1,247 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03372317 · 105 participants
Tau PET in Imaging and Cognition: Healthy Adults From 55-90
- NCT04253964 · 105 participants · Phase 2
Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy
- NCT04742452 · 105 participants · NA
Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears
- NCT04875429 · 105 participants · NA
Zenith® Fenestrated+ Clinical Study
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia