Trial Outcomes & Findings for A Pilot Study of Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging (NCT NCT02633241)
NCT ID: NCT02633241
Last Updated: 2023-06-27
Results Overview
Dosage and consumption of dexmedetomidine infusion
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
71 participants
Primary outcome timeframe
Prior to beginning the MRI and throughout the MRI scan - approximately one hour.
Results posted on
2023-06-27
Participant Flow
Patients were recruited from 3.2.2017 and the final patient was enrolled 9.6.2022. Recruitment occurred after mail and phone contact approximately 2 weeks before the study and consent was obtained on the day of the study.
Participant milestones
| Measure |
Dexmedetomidine (High)-Propofol Arm
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 (2mg/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.
|
Dexmedetomidine (Low)-Propofol Arm
The investigators will administer dexmedetomidine 1 mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 0.5 mcg/kg/hour. At the 5 minute point, propofol will be given (2mg/kg bolus followed by 100 mcg/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 2 mg/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.
|
Dexmedetomidine (Bolus Only)-Propofol Arm
The investigators will administer dexmedetomidine 1 mcg/kg over 5 minutes. At the 5 minute point, propofol will be given (2 mg/kg bolus followed by 100 mcg/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 2 mg/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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
41
|
|
Overall Study
COMPLETED
|
13
|
14
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
Baseline characteristics by cohort
| Measure |
Dexmedetomidine (High)-Propofol Arm
n=13 Participants
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 (2mg/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.
|
Dexmedetomidine (Low)-Propofol Arm
n=14 Participants
The investigators will administer dexmedetomidine 1 mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 0.5 mcg/kg/hour. At the 5 minute point, propofol will be given (2mg/kg bolus followed by 100 mcg/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 2 mg/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.
|
Dexmedetomidine (Bolus Only)-Propofol Arm
n=28 Participants
The investigators will administer dexmedetomidine 1 mcg/kg over 5 minutes. At the 5 minute point, propofol will be given (2 mg/kg bolus followed by 100 mcg/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 2 mg/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.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
13 Participants
n=13 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
14 Participants
n=14 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
28 Participants
n=28 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
55 Participants
n=55 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=13 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
0 Participants
n=14 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
0 Participants
n=28 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
0 Participants
n=55 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=13 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
0 Participants
n=14 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
0 Participants
n=28 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
0 Participants
n=55 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
|
Age, Continuous
|
2.6 years
n=13 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
4.6 years
n=14 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
3.6 years
n=28 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
3.6 years
n=55 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
|
Sex: Female, Male
Female
|
3 Participants
n=13 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
4 Participants
n=14 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
12 Participants
n=28 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
19 Participants
n=55 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
|
Sex: Female, Male
Male
|
10 Participants
n=13 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
10 Participants
n=14 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
16 Participants
n=28 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
36 Participants
n=55 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
13 participants
n=13 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
14 participants
n=14 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
28 participants
n=28 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
55 participants
n=55 Participants • 71 participants were enrolled but only 55 completed the study. Analysis was only performed on these 55 participants.
|
PRIMARY outcome
Timeframe: Prior to beginning the MRI and throughout the MRI scan - approximately one hour.Population: Patients who completed the study and received a dexmedetomidine infusion
Dosage and consumption of dexmedetomidine infusion
Outcome measures
| Measure |
Dexmedetomidine (High)-Propofol Arm
n=13 Participants
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 (2mg/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.
|
Dexmedetomidine (Low)-Propofol Arm
n=14 Participants
First, the investigators will administer dexmedetomidine 1 mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 0.5 mcg/kg/hour. At the 5 minute point, propofol will be given (2 mg/kg bolus followed by 100 mcg/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 2 mg/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.
|
Dexmedetomidine (Bolus Only)-Propofol Arm
First, the investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. At the 5 minute point, propofol will be given (2mg/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 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.
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|---|---|---|---|
|
Dosage/Consumption
|
0.36 mcg/kg/min
Interval 0.22 to 0.51
|
0.25 mcg/kg/min
Interval 0.17 to 0.33
|
—
|
PRIMARY outcome
Timeframe: During the MRI scan, until completion, approximately one hour.If patient moved during their MRI and caused an interruption of the scan.
Outcome measures
| Measure |
Dexmedetomidine (High)-Propofol Arm
n=13 Participants
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 (2mg/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.
|
Dexmedetomidine (Low)-Propofol Arm
n=14 Participants
First, the investigators will administer dexmedetomidine 1 mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 0.5 mcg/kg/hour. At the 5 minute point, propofol will be given (2 mg/kg bolus followed by 100 mcg/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 2 mg/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.
|
Dexmedetomidine (Bolus Only)-Propofol Arm
n=28 Participants
First, the investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. At the 5 minute point, propofol will be given (2mg/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 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.
|
|---|---|---|---|
|
Incidence of Patient Movement and MRI Interruption
|
2 patients
|
3 patients
|
2 patients
|
PRIMARY outcome
Timeframe: 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.arterial desaturation, airway obstruction, hypotension and bradycardia
Outcome measures
| Measure |
Dexmedetomidine (High)-Propofol Arm
n=13 Participants
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 (2mg/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.
|
Dexmedetomidine (Low)-Propofol Arm
n=14 Participants
First, the investigators will administer dexmedetomidine 1 mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 0.5 mcg/kg/hour. At the 5 minute point, propofol will be given (2 mg/kg bolus followed by 100 mcg/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 2 mg/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.
|
Dexmedetomidine (Bolus Only)-Propofol Arm
n=28 Participants
First, the investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. At the 5 minute point, propofol will be given (2mg/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 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.
|
|---|---|---|---|
|
Incidence of Adverse Events
|
1 incidents
Interval 0.0 to 1.0
|
1 incidents
Interval 0.0 to 1.0
|
3 incidents
Interval 0.0 to 3.0
|
PRIMARY outcome
Timeframe: Timeframe immediately before the MRI scan while sedation medication is administered - approximately 10 minutesNumber of minutes from the start of sedation medication administration to the time the patient is adequately sedated for the MRI scan,
Outcome measures
| Measure |
Dexmedetomidine (High)-Propofol Arm
n=13 Participants
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 (2mg/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.
|
Dexmedetomidine (Low)-Propofol Arm
n=14 Participants
First, the investigators will administer dexmedetomidine 1 mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 0.5 mcg/kg/hour. At the 5 minute point, propofol will be given (2 mg/kg bolus followed by 100 mcg/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 2 mg/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.
|
Dexmedetomidine (Bolus Only)-Propofol Arm
n=28 Participants
First, the investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. At the 5 minute point, propofol will be given (2mg/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 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.
|
|---|---|---|---|
|
Case Times
|
7 minutes
Interval 5.5 to 10.0
|
7 minutes
Interval 5.5 to 10.0
|
7 minutes
Interval 5.5 to 10.0
|
SECONDARY outcome
Timeframe: During the MRI scan until completion - approximately one hourlack of adequate sedation for MRI scan in spite of the sedation as described above
Outcome measures
| Measure |
Dexmedetomidine (High)-Propofol Arm
n=13 Participants
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 (2mg/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.
|
Dexmedetomidine (Low)-Propofol Arm
n=14 Participants
First, the investigators will administer dexmedetomidine 1 mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 0.5 mcg/kg/hour. At the 5 minute point, propofol will be given (2 mg/kg bolus followed by 100 mcg/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 2 mg/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.
|
Dexmedetomidine (Bolus Only)-Propofol Arm
n=28 Participants
First, the investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. At the 5 minute point, propofol will be given (2mg/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 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.
|
|---|---|---|---|
|
Incidence of Technique Failure
|
0 incidents
|
0 incidents
|
0 incidents
|
SECONDARY outcome
Timeframe: For the duration of the MRI scan - approximately one hourPopulation: Patients who completed the study and received a dexmedetomidine infusion
The number of minutes that the patient was receiving dexmedetomidine infusion
Outcome measures
| Measure |
Dexmedetomidine (High)-Propofol Arm
n=13 Participants
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 (2mg/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.
|
Dexmedetomidine (Low)-Propofol Arm
n=14 Participants
First, the investigators will administer dexmedetomidine 1 mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 0.5 mcg/kg/hour. At the 5 minute point, propofol will be given (2 mg/kg bolus followed by 100 mcg/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 2 mg/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.
|
Dexmedetomidine (Bolus Only)-Propofol Arm
First, the investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. At the 5 minute point, propofol will be given (2mg/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 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.
|
|---|---|---|---|
|
Sedation Infusion Time
|
43 minutes
Interval 37.0 to 55.0
|
50 minutes
Interval 31.0 to 56.0
|
—
|
SECONDARY outcome
Timeframe: Duration of the MRI scan - approximately one hourtotal number of minutes in the MRI scanner,
Outcome measures
| Measure |
Dexmedetomidine (High)-Propofol Arm
n=13 Participants
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 (2mg/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.
|
Dexmedetomidine (Low)-Propofol Arm
n=14 Participants
First, the investigators will administer dexmedetomidine 1 mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 0.5 mcg/kg/hour. At the 5 minute point, propofol will be given (2 mg/kg bolus followed by 100 mcg/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 2 mg/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.
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Dexmedetomidine (Bolus Only)-Propofol Arm
n=28 Participants
First, the investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. At the 5 minute point, propofol will be given (2mg/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 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.
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|---|---|---|---|
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Case Duration
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52.8 minutes
Standard Deviation 21.2
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53.3 minutes
Standard Deviation 16.8
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40.1 minutes
Standard Deviation 17.4
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SECONDARY outcome
Timeframe: from completion of the MRI scan until prepared for discharge - approximately 90 minutesnumber of minutes in the recovery area until the patient appeared awake (eye opening),
Outcome measures
| Measure |
Dexmedetomidine (High)-Propofol Arm
n=13 Participants
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 (2mg/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.
|
Dexmedetomidine (Low)-Propofol Arm
n=14 Participants
First, the investigators will administer dexmedetomidine 1 mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 0.5 mcg/kg/hour. At the 5 minute point, propofol will be given (2 mg/kg bolus followed by 100 mcg/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 2 mg/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.
|
Dexmedetomidine (Bolus Only)-Propofol Arm
n=28 Participants
First, the investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. At the 5 minute point, propofol will be given (2mg/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 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.
|
|---|---|---|---|
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Recovery Time
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63.5 minutes
Standard Deviation 22
|
60.9 minutes
Standard Deviation 23.6
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42.5 minutes
Standard Deviation 22.4
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Adverse Events
Dexmedetomidine (High)-Propofol Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexmedetomidine (Low)-Propofol Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexmedetomidine (Bolus Only) -Propofol Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place