Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Location status: Recruiting
NCT Number: NCT07369128
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.
Interested in participating?
Request Info1 year–12 year
All sexes
Interventional
Phase 4
Boston, Massachusetts, 02115, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
If patient is randomized to the DLP arm, patient will receive an IV bolus of 0.5 mcg/kg dexmedetomidine over 5 minutes.
Other names: Precedex
If patient is randomized to the P arm, patient will receive 2-4 mg/kg titrated, IV bolus of propofol until sleep is induced.
Other names: Diprivan
If patient is randomized to the DHP arm, patient will receive an IV bolus of 1 mcg/kg dexmedetomidine over 5 minutes.
Other names: Precedex
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.
Other names: Diprivan
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.
Other names: Diprivan
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.
Other names: Diprivan
Time frame: Up to 120 minutes or from induction of anesthesia/sedation to end of MRI scan
The total amount of propofol (mcg/kg/min) consumed will be measured for the duration of anesthesia time for the P, DLP, and DHP arms.
Time frame: Up to 180 minutes or duration of PACU stay
The peak (highest) PAED score will be obtained in the post-anesthesia recovery area (PACU).
Time frame: Up to 240 minutes or from induction of anesthesia/sedation to immediately during recovery
Arterial desaturation, airway obstruction, hypotension and bradycardia
Time frame: Up to 90 minutes or duration of MRI scan
If patient moved during their MRI and caused an interruption of the scan.
Time frame: Up to 120 minutes or from induction of anesthesia/sedation to end of MRI scan
Lack of adequate sedation for MRI scan in spite of the sedation as described above (based on anesthesiologist's discretion or PSSS)
Time frame: Up to 90 minutes or duration of MRI scan
Total number of minutes in the MRI scanner
Time frame: Up to 180 minutes or duration of PACU stay
Total number of minutes in the PACU
Time frame: 10 minutes or from anesthesia induction to MRI scan start
Average Ramsay Sedation Score
Contact information is provided by the study sponsor or research team.
Rachel Bernier, MPH
CONTACT
Samuel Kim, BS
CONTACT
Boston Children's Hospital
Other
A Randomized, Dose-Ranging Trial of Propofol-Only and Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04237792
MRI Sedation
Little Rock, Arkansas, United States
View Trial DetailsNCT07714785
Confusion, Delirium
Santiago, Región, Chile
View Trial DetailsNCT07637357
Bariatric Sleeve Gastrectomy, Cognition Disorders
Istanbul, Sancaktepe, Turkey (Türkiye)
View Trial DetailsNCT07556133
Arrhythmias, Cardiac, Bradycardia
Beirut, Lebanon
View Trial Details