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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 is a Phase 4 study that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 105 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07369128
The ClinicalTrials.gov registry entry for NCT07369128 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Dexmedetomidine (IV) 0.5 mcg/kg is the first listed.
NCT07369128 reports 0 study locations.
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.
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