A Pilot Study of Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging

PHASE4CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

March 2, 2017

Primary Completion Date

September 6, 2022

Study Completion Date

September 6, 2022

Conditions
EpilepsyCerebral PalsyDevelopmental Delay
Interventions
DRUG

Dexmedetomidine bolus and high infusion-Propofol

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.

DRUG

Dexmedetomidine bolus and low infusion-Propofol

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.

DRUG

Dexmedetomidine bolus only - Propofol

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.

Trial Locations (1)

02115

Boston Children's Hospital, Boston

All Listed Sponsors
lead

Joseph Cravero

OTHER

NCT02633241 - A Pilot Study of Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging | Biotech Hunter | Biotech Hunter