MRI SedationPhase 4NCT07369128

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

A Phase 4 study testing Dexmedetomidine (IV) 0.5 mcg/kg, Propofol (IV) 2-4 mg/kg and Dexmedetomidine (IV) 1 mcg/kg in people with MRI Sedation and Pediatric Sedation, run by Boston Children's Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 1 year to 12 years
Conditions the study is for: MRI Sedation, Pediatric Sedation, Propofol Dosage
What is being tested?: Dexmedetomidine (IV) 0.5 mcg/kg, Propofol (IV) 2-4 mg/kg and Dexmedetomidine (IV) 1 mcg/kg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: 1 siteUnited States
Study dates: 30 Jun 2026to Mar 2028
Phase: Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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.

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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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Samuel Kim, BS contact

617-919-3692

samuel.kim@childrens.harvard.edu

Rachel Bernier, MPH contact

857-218-5348

rachel.bernier@childrens.harvard.edu

United States1 site, 1 recruiting

Boston Children's Hospital
Boston, Massachusetts, 02115
Joseph Cravero, MD, joseph.cravero@childrens.harvard.edu
Recruiting

Other trials in United States

About this study

Official title: A Randomized, Dose-Ranging Trial of Propofol-Only and 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.

Conditions: MRI Sedation, Pediatric Sedation, Propofol Dosage, Emergence Delirium, Anesthesia, Recovery Time, Dexmedetomidine
Being tested: Dexmedetomidine (IV) 0.5 mcg/kg, Propofol (IV) 2-4 mg/kg, Dexmedetomidine (IV) 1 mcg/kg, Propofol (IV) 1-2 mg/kg, Propofol (IV) Infusion 250 mcg/kg/min
Keywords: pediatrics, sedation, dexmedetomidine, propofol, MRI
Medical subject headings: Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dexmedetomidine (IV) 0.5 mcg/kgDrug
Also called Precedex
If patient is randomized to the DLP arm, patient will receive an IV bolus of 0.5 mcg/kg dexmedetomidine over 5 minutes.
Propofol (IV) 2-4 mg/kgDrug
Also called Diprivan
If patient is randomized to the P arm, patient will receive 2-4 mg/kg titrated, IV bolus of propofol until sleep is induced.
Dexmedetomidine (IV) 1 mcg/kgDrug
Also called Precedex
If patient is randomized to the DHP arm, patient will receive an IV bolus of 1 mcg/kg dexmedetomidine over 5 minutes.
Propofol (IV) 1-2 mg/kgDrug
Also called Diprivan
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.
Propofol (IV) Infusion 250 mcg/kg/minDrug
Also called Diprivan
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.
Propofol (IV) Infusion 150 mcg/kg/minDrug
Also called Diprivan
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.

Study groups in NCT07369128
Study group	Role	What they receive
Propofol Only (P)	Active comparator	1 mg/kg (max 25 kg) of IV lidocaine (standard of care) will be given. 2-4 mg/kg titrated bolus of propofol will be administered, which can be repeated 2x until a Ramsay Sedation Score of 5-6 is achieved. After that, 250 mcg/kg/min infusion of propofol will be initiated and can be titrated up to a maximum of 300 mcg/kg/min to maintain a Ramsay Sedation Score of 5-6. If not sedated after 5 more minutes, record a technique failure and continue sedation at anesthesiologist's discretion. Per standard of care, the propofol infusion may be decreased if the blood pressure decreases by more than 30% from lowest expected norms or if there is any indication of possible airway obstruction. Receives: Drug: Propofol (IV) 2-4 mg/kg; Drug: Propofol (IV) Infusion 250 mcg/kg/min
Dexmedetomidine (high)-Propofol (DHP)	Active comparator	1 mcg/kg dexmedetomidine (DEX) bolus over 5-10 minutes will be delivered by fractionated doses or infusion. After the DEX bolus is complete, 1 mg/kg (max 25 mg) of IV lidocaine will be administered followed by a dose of 2-3 mg/kg titrated bolus of propofol (P), which can be repeated 2x until a Ramsay Sedation Score of 5-6 is achieved. After this, 150 mcg/kg/min infusion of P will be initiated. If the Ramsay Sedation score of 5-6 is not achieved within 2 minutes, 1-2 mg/kg bolus of P may be administered and P infusion will be increased to 200 mcg/kg/min. The P infusion can be titrated up to a maximum of 300 mcg/kg/min if needed to maintain a Ramsay Sedation Score of 5-6. If not sedated after 5 more minutes, record a technique failure and continue sedation at anesthesiologist's discretion. Per standard of care, the propofol infusion may be decreased if the blood pressure decreases by more than 30% from lowest expected norms or if there is any indication of possible airway obstruction. Receives: 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	0.5 mcg/kg dexmedetomidine (DEX) bolus over 5-10 minutes will be delivered by fractionated doses or infusion. After the DEX bolus is complete, 1 mg/kg (max 25 mg) of IV lidocaine will be administered followed by a dose of 2-3 mg/kg titrated bolus of propofol (P), which can be repeated 2x until a Ramsay Sedation Score of 5-6 is achieved. After this, 150 mcg/kg/min infusion of P will be initiated. If the Ramsay Sedation score of 5-6 is not achieved within 2 minutes, 1-2 mg/kg bolus of P may be administered and P infusion will be increased to 200 mcg/kg/min. The P infusion can be titrated up to a maximum of 300 mcg/kg/min if needed to maintain a Ramsay Sedation Score of 5-6. If not sedated after 5 more minutes, record a technique failure and continue sedation at anesthesiologist's discretion. Per standard of care, the propofol infusion may be decreased if the blood pressure decreases by more than 30% from lowest expected norms or if there is any indication of possible airway obstruction. Receives: Drug: Dexmedetomidine (IV) 0.5 mcg/kg; Drug: Propofol (IV) 1-2 mg/kg; Drug: Propofol (IV) Infusion 150 mcg/kg/min

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

Peak Pediatric Anesthesia Emergence Delirium (PAED) Score
The peak (highest) PAED score will be obtained in the post-anesthesia recovery area (PACU).
Measured: Up to 180 minutes or duration of PACU stay
Incidence of Adverse Events
Arterial desaturation, airway obstruction, hypotension and bradycardia
Measured: Up to 240 minutes or from induction of anesthesia/sedation to immediately during recovery
Incidences of Patient Movements/MRI Interruptions
If patient moved during their MRI and caused an interruption of the scan.
Measured: Up to 90 minutes or duration of MRI scan
Incidence of Technique Failure
Lack of adequate sedation for MRI scan in spite of the sedation as described above (based on anesthesiologist's discretion or PSSS)
Measured: Up to 120 minutes or from induction of anesthesia/sedation to end of MRI scan
Case Duration
Total number of minutes in the MRI scanner
Measured: Up to 90 minutes or duration of MRI scan
Post Anesthesia Care Unit (PACU) Duration
Total number of minutes in the PACU
Measured: Up to 180 minutes or duration of PACU stay
Ramsay Sedation Score
Average Ramsay Sedation Score
Measured: 10 minutes or from anesthesia induction to MRI scan start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 2026Mar 2028

First posted27 Jan 2026
Study start30 Jun 2026
Primary completionDec 2027 (estimated)
Study completionMar 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for MRI SedationStudies of the same condition, open and under way.
More trials run by Boston Children's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 105 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07369128
Sponsor's protocol ID: IRB-P00052391
Status last verified: Jan 2026
First submitted: 24 Jan 2026
Last updated: 21 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 29882298
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.
PubMed 36620110
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.
PubMed 27779360
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.
PubMed 34036674
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.
PubMed 40349256
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.
PubMed 25714157
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.
PubMed 36173243