NCT02633241|CompletedPhase 4ResultsDMCFDA Drug
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Sponsor study identifier
interventional
71
1 country
1
Study Start
March 2, 2017
Actual (reported)Primary Completion
September 6, 2022
Actual (reported)Study Completion
September 6, 2022
Actual (reported)This is a pilot study to determine if a standard bolus dose and infusion of dexmedetomidine can significantly decrease the dose of propofol (infusion) required for accomplishing an MRI. The investigators studied three arms to examine the effectiveness of dexmedetomidine. Arm 1 was a single bolus of 1.0 mcg/kg with 1.0 mcg/kg/hr infusion followed by propofol infusion. Arm 2 was a bolus of 1.0 mcg/kg with 0.5 mcg/kg/hr infusion followed by propofol infusion. Arm 3 was only a single bolus of 1.0 mcg/kg with no infusion followed by propofol infusion.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 6, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 11, 2015
Actual (reported)December 17, 2015
Actual (reported)March 2, 2017
Actual (reported)August 28, 2019
Actual (reported)September 6, 2022
Actual (reported)September 6, 2022
Actual (reported)Dosage/Consumption
Dosage and consumption of dexmedetomidine infusion
Prior to beginning the MRI and throughout the MRI scan - approximately one hour.
Incidence of Patient Movement and MRI Interruption
If patient moved during their MRI and caused an interruption of the scan.
During the MRI scan, until completion, approximately one hour.
Incidence of Adverse Events
arterial desaturation, airway obstruction, hypotension and bradycardia
From the time the medication is initiated just (5 minutes) prior to the MRI scan and during the MRI scan and immediately during recovery - approximately one hour and twenty minutes in total.
Patients in this cohort will receive a combination of Dexmedetomidine 1mcg/kg bolus, Dexmedetomidine 1 mcg/kg/hour infusion, and Propofol 100mcg/kg/minute to accomplish an MRI examination.
Patients in this cohort will receive a combination of Dexmedetomidine 1mcg/kg bolus, Dexmedetomidine 0.5 mcg/kg/hour infusion, and Propofol 100mcg/kg/minute to accomplish an MRI examination.
First, the investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 1mcg/kg/hour. At the 5 minute point, propofol will be given (2-3mg/kg bolus followed by 100mcg/kg/min infusion). The attending clinician will determine whether or not the child is in an adequate state to begin the MRI scan. If the sedative effect of the dexmedetomidine-propofol does not produce a sufficiently sedated state within 10 minutes, a repeat bolus of propofol 2mg/kg will be administered. The dose of Dexmedetomidine will not be changed. The dose will be repeated if the child is not adequately sedated in 2 more minutes. At this time infusion rate of propofol will be increased to 200 mcg/kg/minute. If the child is not sedated in 5 more minutes, the outcome will be recorded as a technique failure and sedation will continue at the discretion of the anesthesiologist.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Dexmedetomidine bolus and high infusion-Propofol
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Dexmedetomidine bolus and low infusion-Propofol
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordBoston Children's Hospital
Boston, Massachusetts, 02115, United States
Rappaport BA, Suresh S, Hertz S, Evers AS, Orser BA. Anesthetic neurotoxicity--clinical implications of animal models. N Engl J Med. 2015 Feb 26;372(9):796-7. doi: 10.1056/NEJMp1414786.
Wu J, Mahmoud M, Schmitt M, Hossain M, Kurth D. Comparison of propofol and dexmedetomedine techniques in children undergoing magnetic resonance imaging. Paediatr Anaesth. 2014 Aug;24(8):813-8. doi: 10.1111/pan.12408. Epub 2014 May 12.
Joseph Cravero, MD
Boston Children's Hospital
71 participants (actual enrollment reported by the registry).
First Submitted
December 11, 2015
First Posted
December 17, 2015
Study Start
March 2, 2017
Actual (reported)Clobazam Adjunctive Treatment of Adults With Refractory Focal Epilepsy
Case Times
Number of minutes from the start of sedation medication administration to the time the patient is adequately sedated for the MRI scan,
Timeframe immediately before the MRI scan while sedation medication is administered - approximately 10 minutes
Incidence of Technique Failure
During the MRI scan until completion - approximately one hour
Sedation Infusion Time
For the duration of the MRI scan - approximately one hour
Case Duration
Duration of the MRI scan - approximately one hour
Recovery Time
from completion of the MRI scan until prepared for discharge - approximately 90 minutes
Patients in this cohort will receive dexmedetomidine 1mcg/kg over 5 minutes and then propofol 2-3mg/kg titrated bolus followed by 100mcg/kg/min infusion to accomplish MRI
First, the investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 0.5mcg/kg/hour. At the 5 minute point, propofol will be given (2-3mg/kg bolus followed by 100mcg/kg/min infusion). The attending clinician will determine whether or not the child is in an adequate state to begin the MRI scan. If the sedative effect of the dexmedetomidine-propofol does not produce a sufficiently sedated state within 10 minutes, a repeat bolus of propofol 2mg/kg will be administered. The dose of Dexmedetomidine will not be changed. The dose will be repeated if the child is not adequately sedated in 2 more minutes. At this time infusion rate of propofol will be increased to 200 mcg/kg/minute. If the child is not sedated in 5 more minutes, the outcome will be recorded as a technique failure and sedation will continue at the discretion of the anesthesiologist.
First, the investigators will begin by administering dexmedetomidine 1mcg/kg over 5 minutes. When this is completed, they will administer propofol 2-3mg/kg titrated bolus followed by 100mcg/kg/min infusion which can also be titrated up or down to a maximum of 300mcg/kg/min to keep the blood pressure and heart rate within 30% of baseline levels.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Heard CM, Joshi P, Johnson K. Dexmedetomidine for pediatric MRI sedation: a review of a series of cases. Paediatr Anaesth. 2007 Sep;17(9):888-92. doi: 10.1111/j.1460-9592.2007.02272.x.
Triltsch AE, Welte M, von Homeyer P, Grosse J, Genahr A, Moshirzadeh M, Sidiropoulos A, Konertz W, Kox WJ, Spies CD. Bispectral index-guided sedation with dexmedetomidine in intensive care: a prospective, randomized, double blind, placebo-controlled phase II study. Crit Care Med. 2002 May;30(5):1007-14. doi: 10.1097/00003246-200205000-00009.
Primary Completion
September 6, 2022
Actual (reported)Study Completion
September 6, 2022
Actual (reported)Last Updated
June 27, 2023
Results First Posted
August 28, 2019
Record last verified: 2023-06
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Source: ClinicalTrials.gov.
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