Propofol-Only Versus Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging
Key facts
- Who runs it
- Boston Children's Hospital
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 105 people, planned
- Started
- 30 Jun 2026
- Expected to end
- Mar 2028
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments 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
- Propofol (IV) Infusion 150 mcg/kg/min
- Record updated
- 21 September 2026
Who can take part
- Age
- 1 year to 12 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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 take part
- Anxiolytic medication is ordered before the MRI (e.g., midazolam or ketamine)
- Received within the past 12 hours an oral or intravenous alpha-adrenergic, beta-adrenergic agonist, or antagonist drugs (e.g., clonidine, propranolol, albuterol)
- Congenital heart disease or history of dysrhythmia
- History or a family (parent or sibling) history of malignant hyperthermia
- Allergy to or has a contraindication to propofol, lidocaine, or dexmedetomidine
- 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
- Taking digoxin or beta-blocker
- Tracheostomy or other mechanical airway device present
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 12 years old?
Where in United States
- Boston Children's HospitalBoston, United StatesContact: Joseph Cravero, MDTaking people
About the trial
What the trial wants to find out
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.
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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.
The 3 groups in the trial
- Propofol Only (P)Existing treatment, for comparison
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.
Treatment: Propofol (IV) 2-4 mg/kg and Propofol (IV) Infusion 250 mcg/kg/min
- Dexmedetomidine (high)-Propofol (DHP)Existing treatment, for comparison
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.
Treatment: Dexmedetomidine (IV) 1 mcg/kg, Propofol (IV) 1-2 mg/kg, and Propofol (IV) Infusion 150 mcg/kg/min
- Dexmedetomidine (low)-Propofol (DLP)Existing treatment, for comparison
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.
Treatment: Dexmedetomidine (IV) 0.5 mcg/kg, Propofol (IV) 1-2 mg/kg, and Propofol (IV) Infusion 150 mcg/kg/min
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Randomized, Dose-Ranging Trial of Propofol-Only and Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging
- Fit questions
- Built from NCT07369128, who can take part
- Record updated
- 21 September 2026