Dexmedetomidine + Propofol for Pediatric Sedation
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Joseph Cravero, MD
Principal Investigator
Boston Children's Hospital
Are You a Good Fit for This Trial?
This trial is for children aged 1-12 who need sedation for an MRI scan. They should be healthy or have mild systemic disease (ASA I, II, III) and can breathe on their own during the procedure. It's not suitable for kids who aren't fit for the described sedation method.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive sedation with either Propofol only or Dexmedetomidine-Propofol combination for MRI scans
Post-Anesthesia Recovery
Participants are monitored in the PACU for recovery and adverse events
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dexmedetomidine
- Propofol
Trial Overview
The study compares different doses of Propofol alone versus a combination of Dexmedetomidine and Propofol in pediatric patients undergoing MRI to find the best balance between effective sedation and quick recovery without increasing neurotoxic risks.
How Is the Trial Designed?
3
Treatment groups
Active Control
If randomized to the P arm, the patient will receive a 2-4 mg/kg titrated IV bolus of propofol until sleep is induced. 250 mcg/kg/min infusion of IV propofol will then be started.
If randomized to the DHP arm, patient will receive an IV bolus of 1 mcg/kg of dexmedetomidine followed by a 1-2 mg/kg titrated IV bolus of propofol until sleep. 150 mcg/kg/min infusion of IV propofol will then be started. If not sedated within 10 minutes: 1-2 mg/kg bolus of propofol. If not sedated within 2 more minutes: 1-2 mg/kg bolus of propofol and increase propofol infusion to 200 mcg/kg/min (Can be titrated up to a maximum of 300 mcg/kg/min). If not sedated after 5 more minutes, record a technique failure and continue sedation at anesthesiologist's discretion.
If randomized to the DLP arm, patient will receive an IV bolus of 0.5 mcg/kg of dexmedetomidine followed by a 1-2 mg/kg titrated IV bolus of propofol until sleep. 150 mcg/kg/min infusion of IV propofol will then be started. If not sedated within 10 minutes: 1-2 mg/kg bolus of propofol. If not sedated within 2 more minutes: 1-2 mg/kg bolus of propofol and increase propofol infusion to 200 mcg/kg/min (Can be titrated up to a maximum of 300 mcg/kg/min). If not sedated after 5 more minutes, record a technique failure and continue sedation at anesthesiologist's discretion.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor
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