Actively Recruiting

Phase 4
Age: 1Year - 12Years
All Genders
ID07369128

A Randomized, Dose-Ranging Trial of Propofol-Only and Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging

Led by Boston Children's Hospital · Updated on 2026-05-29

105

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating sedation methods for children aged 1 to 12 years undergoing magnetic resonance imaging (MRI). The study focuses on comparing the use of propofol alone versus a combination of dexmedetomidine and propofol to find the best sedation approach that minimizes anesthetic exposure while maintaining effective sedation. This research is motivated by concerns about possible neurotoxic effects of common anesthetics and the potential benefits of dexmedetomidine, which may reduce risks like airway collapse and pulmonary issues. Participants will be randomly assigned to one of three sedation plans: propofol only, high-dose dexmedetomidine with propofol, or low-dose dexmedetomidine with propofol. Each plan involves specific dosing schedules, including intravenous boluses and continuous propofol infusions, adjusted to maintain a targeted sedation level. Lidocaine is also given as part of the standard care protocol. The study aims to find the optimal dose of dexmedetomidine combined with propofol that provides adequate sedation without prolonging recovery time. During the MRI procedure, sedation depth will be closely monitored using sedation scores, and researchers will track propofol consumption, recovery duration, and any adverse events or interruptions. Various assessments will be conducted during and after the MRI, including measuring emergence delirium and sedation scores, as well as observing patient movements and technique failures. The total observation time includes the MRI scan and post-anesthesia care unit (PACU) stay, ensuring comprehensive safety and effectiveness monitoring throughout the sedation and recovery periods.

CONDITIONS

Brief Title

Propofol-Only Versus Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging

Who Can Participate

Age: 1Year - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled as outpatients for anesthesia during MRI of brain, body, or extremities
  • Candidates for sedation technique with natural airway as decided by anesthesiology staff
  • Age between 1 and 12 years
  • ASA status I, II, or III
Not Eligible

You will not qualify if you...

  • Inpatients at Boston Children's Hospital
  • Diagnosis of difficult airway or severe obstructive sleep apnea incompatible with spontaneous breathing
  • Congenital heart disease or history of heart rhythm problems
  • Taking digoxin or beta-blocker medication
  • Use of anxiolytic drugs before MRI (e.g., midazolam or ketamine)
  • Personal or family history of malignant hyperthermia
  • Allergy or contraindication to propofol, lidocaine, or dexmedetomidine
  • Presence of tracheostomy or mechanical airway device
  • Use of alpha- or beta-adrenergic drugs within past 12 hours
  • Not scheduled for anesthesia-sedation or planned try-without anesthesia for MRI
  • Significant developmental or psychological delays
  • MRI scan expected to last less than 30 minutes or more than 90 minutes

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 90 minutes or duration of MRI scan

Participants receive sedation with either propofol only or a combination of dexmedetomidine and propofol during their MRI procedure. Sedation includes IV boluses and infusions to achieve and maintain a specific sedation level.

1 visit (in-person) on the day of MRI

Post-anesthesia Care

Duration - Up to 180 minutes or duration of PACU stay

Participants are monitored in the Post Anesthesia Care Unit (PACU) following sedation until recovery is adequate.

Approximately 1 follow-up visit (in-person) immediately after MRI

Trial Site Locations

Total: 1 location

1

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

S

Samuel Kim, BS

R

Rachel Bernier, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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Published Research Related To This Trial

The Effectiveness of Three Regimens of Sedation for Children Undergoing Magnetic Resonance Imaging: A Clinical Study.

Shwethashri Kondavagilu Ramaprasannakumar, Varadarajan Bhadrinarayan, Sudhir Venkataramaiah

https://pubmed.ncbi.nlm.nih.gov/36620110

A retrospective comparison of propofol alone to propofol in combination with dexmedetomidine for pediatric 3T MRI sedation.

Juan P Boriosi, Jens C Eickhoff, Kristi B Klein...

https://pubmed.ncbi.nlm.nih.gov/27779360