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Compares treatment options for MRI Sedation
Official title Propofol-Only Versus Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging
ClinicalTrials.gov ID: NCT07369128
What this study is testing
What is Dexmedetomidine (IV) 0.5 mcg/kg?
Dexmedetomidine (IV) 0.5 mcg/kg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for mri sedation.
Also referred to as Precedex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 12
You may be able to join if
- Patients presenting as outpatients, scheduled to receive an anesthetic for MRI of brain, body (spine, chest, abdomen, and/or pelvis) and/or extremity...
- 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...
- Between 1 and 12 years of age.
- ASA status I, II, or III
You likely can't join if
- 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...
- 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.
See the full eligibility 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
- 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 \ 90 minutes
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.