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

NCT07369128 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB-P00052391
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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 the dose that would provide the optimal sedation for these scans and minimize excess anesthetic exposure.

Conditions

MRI Sedation; Pediatric Sedation; Propofol Dosage; Emergence Delirium, Anesthesia; Recovery Time; Dexmedetomidine

Keywords

pediatrics; sedation; dexmedetomidine; propofol; MRI

Outcome Measures

Primary Outcomes (1)

• Total Propofol (mcg/kg/min) consumption

  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.

  Up to 120 minutes or from induction of anesthesia/sedation to end of MRI scan

Secondary Outcomes (6)

• Peak Pediatric Anesthesia Emergence Delirium (PAED) Score

  Up to 180 minutes or duration of PACU stay

• Incidence of Adverse Events

  Up to 240 minutes or from induction of anesthesia/sedation to immediately during recovery

• Incidences of Patient Movements/MRI Interruptions

  Up to 90 minutes or duration of MRI scan

• Incidence of Technique Failure

  Up to 120 minutes or from induction of anesthesia/sedation to end of MRI scan

• Case Duration

  Up to 90 minutes or duration of MRI scan

Study Arms (3)

Propofol Only (P)

ACTIVE COMPARATOR

If randomized to the P arm, the patient will receive a 2-4 mg/kg titrated IV bolus of propofol until sleep is induced. 250 mcg/kg/min infusion of IV propofol will then be started.

Drug: Propofol (IV) 2-4 mg/kg; Drug: Propofol (IV) Infusion 250 mcg/kg/min

Dexmedetomidine (high)-Propofol (DHP)

ACTIVE COMPARATOR

If randomized to the DHP arm, patient will receive an IV bolus of 1 mcg/kg of dexmedetomidine followed by a 1-2 mg/kg titrated IV bolus of propofol until sleep. 150 mcg/kg/min infusion of IV propofol will then be started. If not sedated within 10 minutes: 1-2 mg/kg bolus of propofol. If not sedated within 2 more minutes: 1-2 mg/kg bolus of propofol and increase propofol infusion to 200 mcg/kg/min (Can be titrated up to a maximum of 300 mcg/kg/min). If not sedated after 5 more minutes, record a technique failure and continue sedation at anesthesiologist's discretion.

Drug: Dexmedetomidine (IV) 1 mcg/kg; Drug: Propofol (IV) 1-2 mg/kg; Drug: Propofol (IV) Infusion 150 mcg/kg/min

Dexmedetomidine (low)-Propofol (DLP)

ACTIVE COMPARATOR

If randomized to the DLP arm, patient will receive an IV bolus of 0.5 mcg/kg of dexmedetomidine followed by a 1-2 mg/kg titrated IV bolus of propofol until sleep. 150 mcg/kg/min infusion of IV propofol will then be started. If not sedated within 10 minutes: 1-2 mg/kg bolus of propofol. If not sedated within 2 more minutes: 1-2 mg/kg bolus of propofol and increase propofol infusion to 200 mcg/kg/min (Can be titrated up to a maximum of 300 mcg/kg/min). If not sedated after 5 more minutes, record a technique failure and continue sedation at anesthesiologist's discretion.

Drug: Dexmedetomidine (IV) 0.5 mcg/kg; Drug: Propofol (IV) 1-2 mg/kg; Drug: Propofol (IV) Infusion 150 mcg/kg/min

Interventions

Dexmedetomidine (IV) 0.5 mcg/kg DRUG

If patient is randomized to the DLP arm, patient will receive an IV bolus of 0.5 mcg/kg dexmedetomidine over 5 minutes.

Also known as: Precedex

Dexmedetomidine (low)-Propofol (DLP)

Propofol (IV) 2-4 mg/kg DRUG

If patient is randomized to the P arm, patient will receive 2-4 mg/kg titrated, IV bolus of propofol until sleep is induced.

Also known as: Diprivan

Propofol Only (P)

Dexmedetomidine (IV) 1 mcg/kg DRUG

If patient is randomized to the DHP arm, patient will receive an IV bolus of 1 mcg/kg dexmedetomidine over 5 minutes.

Also known as: Precedex

Dexmedetomidine (high)-Propofol (DHP)

Propofol (IV) 1-2 mg/kg DRUG

If the patient is randomized to the DLP or DHP arm, following the dexmedetomidine bolus, the patient will receive a titrated, IV bolus of 1-2 mg/kg propofol.

Also known as: Diprivan

Dexmedetomidine (high)-Propofol (DHP); Dexmedetomidine (low)-Propofol (DLP)

Propofol (IV) Infusion 250 mcg/kg/min DRUG

If the patient is randomized to the P arm, following the bolus of propofol, the patient will be started on an IV propofol infusion of 250 mcg/kg/min.

Also known as: Diprivan

Propofol Only (P)

Propofol (IV) Infusion 150 mcg/kg/min DRUG

If the patient is randomized to the DLP or DHP arm, following the titrated propofol bolus, the patient will be started on an IV propofol infusion of 150 mcg/kg/min.

Also known as: Diprivan

Dexmedetomidine (high)-Propofol (DHP); Dexmedetomidine (low)-Propofol (DLP)

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients presenting as outpatients, scheduled to receive an anesthetic for MRI of brain, body (spine, chest, abdomen, and/or pelvis) and/or extremity (arm and/or leg).
• Patients must be a candidate for the sedation technique described in this study with a natural airway. This decision will be made by a staff member of the Department of Anesthesiology.
• Between 1 and 12 years of age.
• ASA status I, II, or III

You may not qualify if:

• Inpatient at BCH
• Diagnosis of a difficult airway, severe obstructive sleep apnea that is not compatible with spontaneous ventilation in a supine position, or requires an oral airway.
• Congenital heart disease or history of dysrhythmia.
• Taking digoxin or beta-blocker
• Anxiolytic medication is ordered before the MRI (e.g., midazolam or ketamine).
• History or a family (parent or sibling) history of malignant hyperthermia.
• Allergy to or has a contraindication to propofol or dexmedetomidine.
• Tracheostomy or other mechanical airway device present
• Received within the past 12 hours an oral or intravenous alpha-adrenergic, beta-adrenergic agonist, or antagonist drugs (e.g., clonidine, propranolol, albuterol).
• Patient is not scheduled to receive anesthesia-sedation care or is noted to "try-without anesthesia" for the MRI
• Patient has significant developmental or psychological delays
• Patient scheduled for scan of duration \<30 minutes or \>90 minutes

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (7)

• Nagoshi M, Reddy S, Bell M, Cresencia A, Margolis R, Wetzel R, Ross P. Low-dose dexmedetomidine as an adjuvant to propofol infusion for children in MRI: A double-cohort study. Paediatr Anaesth. 2018 Jul;28(7):639-646. doi: 10.1111/pan.13400. Epub 2018 Jun 7.

  PMID: 29882298 BACKGROUND

• Ramaprasannakumar SK, Bhadrinarayan V, Venkataramaiah S. The Effectiveness of Three Regimens of Sedation for Children Undergoing Magnetic Resonance Imaging: A Clinical Study. Anesth Essays Res. 2022 Jul-Sep;16(3):345-352. doi: 10.4103/aer.aer_45_22. Epub 2022 Dec 9.

  PMID: 36620110 BACKGROUND

• Boriosi JP, Eickhoff JC, Klein KB, Hollman GA. A retrospective comparison of propofol alone to propofol in combination with dexmedetomidine for pediatric 3T MRI sedation. Paediatr Anaesth. 2017 Jan;27(1):52-59. doi: 10.1111/pan.13041. Epub 2016 Oct 25.

  PMID: 27779360 BACKGROUND

• Vinson AE, Peyton J, Kordun A, Staffa SJ, Cravero J. Trends in Pediatric MRI sedation/anesthesia at a tertiary medical center over time. Paediatr Anaesth. 2021 Sep;31(9):953-961. doi: 10.1111/pan.14225. Epub 2021 Jun 22.

  PMID: 34036674 BACKGROUND

• Kim SY, Booth JM, Staffa SJ, Kordun A, Yu J, Cravero JP. A dose-ranging pilot trial of dexmedetomidine-propofol in children undergoing magnetic resonance imaging. J Anesth. 2025 Dec;39(6):989-994. doi: 10.1007/s00540-025-03511-z. Epub 2025 May 11.

  PMID: 40349256 BACKGROUND

• Rappaport BA, Suresh S, Hertz S, Evers AS, Orser BA. Anesthetic neurotoxicity--clinical implications of animal models. N Engl J Med. 2015 Feb 26;372(9):796-7. doi: 10.1056/NEJMp1414786.

  PMID: 25714157 BACKGROUND

• Mallory MD, Travers C, Cravero JP, Kamat PP, Tsze D, Hertzog JH. Pediatric Sedation/Anesthesia for MRI: Results From the Pediatric Sedation Research Consortium. J Magn Reson Imaging. 2023 Apr;57(4):1106-1113. doi: 10.1002/jmri.28392. Epub 2022 Aug 12.

  PMID: 36173243 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Propofol

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Joseph Cravero, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Kim, BS

CONTACT

617-919-3692; samuel.kim@childrens.harvard.edu

Rachel Bernier, MPH

CONTACT

857-218-5348; rachel.bernier@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesia, Critical Care and Pain Medicine, Principal Investigator

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: January 27, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)