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NCT Number: NCT07369128

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 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.

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Key information

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Joseph Cravero, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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, lidocaine, 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

Treatment and study plan

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.

Other names: Precedex

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.

Other names: Diprivan

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.

Other names: Precedex

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.

Other names: Diprivan

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.

Other names: Diprivan

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.

Other names: Diprivan

Primary outcomes

  1. Total Propofol (mcg/kg/min) consumption

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

    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.

Secondary outcomes

  1. Peak Pediatric Anesthesia Emergence Delirium (PAED) Score

    Time frame: Up to 180 minutes or duration of PACU stay

    The peak (highest) PAED score will be obtained in the post-anesthesia recovery area (PACU).

  2. Incidence of Adverse Events

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

    Arterial desaturation, airway obstruction, hypotension and bradycardia

  3. Incidences of Patient Movements/MRI Interruptions

    Time frame: Up to 90 minutes or duration of MRI scan

    If patient moved during their MRI and caused an interruption of the scan.

  4. Incidence of Technique Failure

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

    Lack of adequate sedation for MRI scan in spite of the sedation as described above (based on anesthesiologist's discretion or PSSS)

  5. Case Duration

    Time frame: Up to 90 minutes or duration of MRI scan

    Total number of minutes in the MRI scanner

  6. Post Anesthesia Care Unit (PACU) Duration

    Time frame: Up to 180 minutes or duration of PACU stay

    Total number of minutes in the PACU

  7. Ramsay Sedation Score

    Time frame: 10 minutes or from anesthesia induction to MRI scan start

    Average Ramsay Sedation Score

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Bernier, MPH

CONTACT

[email protected]

857-218-5348

Samuel Kim, BS

CONTACT

[email protected]

617-919-3692

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 27, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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