Propofol-only vs dexmedetomidine-propofol for sedation in children undergoing MRI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional phase 4 trial compares two sedation regimens for pediatric MRI: propofol alone versus a combination of dexmedetomidine and propofol. Children aged 1 to 12 years requiring MRI and with a suitable airway are enrolled and randomized to receive either regimen, with dosing strategies including IV dexmedetomidine and propofol as specified. The study aims to assess outcomes such as emergence behavior, recovery time, and safety in a real-world outpatient setting at Boston Children’s Hospital. The approach builds on prior evidence suggesting dexmedetomidine may reduce airway events and potentially offer neuroprotective advantages compared with propofol alone. Results could inform optimal sedation strategies for pediatric MRI procedures.

Why it matters

Who can join: the full rules

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

Where it's running

• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Joseph Cravero, MD — Boston Children's Hospital
• Study coordinator: Samuel Kim, BS
• Email: samuel.kim@childrens.harvard.edu
• Phone: 617-919-3692

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sedation with dexmedetomidine, propofol, or both during cataract surgery

  This project will test whether dexmedetomidine, propofol, or their combination (each given with fentanyl) provides the best sedation, safety, and surgeon satisfaction for adults having cataract surgery.

  Recruiting Saint-Joseph University · Beirut · NCT07556133

• Dexmedetomidine to See if Delirium Drops After Hip Fracture Surgery

  This observational study tests whether using dexmedetomidine around hip fracture surgery helps prevent postoperative delirium in adults 65 and older.

  Recruiting Aarhus University Hospital · Aarhus · NCT07867899

• Esmolol vs Dexmedetomidine for opioid-sparing in laparoscopic gynecologic surgery

  This study tests whether low-dose esmolol or dexmedetomidine, given during surgery, reduces opioid use and improves pain control after laparoscopic hysterectomy compared with placebo.

  Recruiting National and Kapodistrian University of Athens · Athens · NCT07846722

• Dexmedetomidine with taVNS to see if PTSD after trauma surgery can be reduced

  This study tests whether giving dexmedetomidine together with transcutaneous vagus nerve stimulation after emergency trauma surgery can lower the chances of developing PTSD.

  Recruiting Affiliated Hospital of Nantong University · Nantong, Jiangsu · NCT07813962

• Propofol vs. Dexmedetomidine for Preventing Emergence Agitation in Children After Sevoflurane Anesthesia

  This trial tests whether a single dose of propofol or a single dose of dexmedetomidine, given after surgery, better prevents emergence agitation in children recovering from sevoflurane anesthesia.

  Recruiting Phase 4 Pakistan Institute of Medical Sciences · Islamabad, Federal · NCT07799311

• Dexmedetomidine vs magnesium as intraperitoneal add-ons to bupivacaine for laparoscopic gallbladder removal

  This study tests whether adding dexmedetomidine or magnesium sulfate to bupivacaine injected inside the abdomen provides better pain relief after laparoscopic cholecystectomy for adults without serious health issues.

  Recruiting Alexandria University · Alexandria · NCT07693621

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.