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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

1 Year - 12 Years

Healthy Volunteers

Not accepted

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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study Details

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.

Key Dates

Start date

Jun 30, 2026

Status verified

Jan 2026

Primary completion

Dec 31, 2027

Completion

Mar 31, 2028

Study Design

Enrollment

105 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Active Comparator: Propofol Only (P)
  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.
• Active Comparator: Dexmedetomidine (high)-Propofol (DHP)
  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.
• Active Comparator: Dexmedetomidine (low)-Propofol (DLP)
  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.

Primary Outcome Measure

Total Propofol (mcg/kg/min) consumption [ Time Frame: Up to 120 minutes or from induction of anesthesia/sedation to end of MRI scan ]

Central Contacts

• Samuel Kim, BS
  617-919-3692
  [email protected]
• Rachel Bernier, MPH
  857-218-5348
  [email protected]

Locations (1)

Find similar trials in Boston, MA

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