Safety and Efficacy of Sedation Medications
Conditions
Keywords
dexmedetomidine, propofol, sedation, MRI, scanning, pediatric, children, Magnetic Resonance Imaging
Brief summary
This is a prospective, open label randomized study. The purpose of this study is to compare propofol with dexmedetomidine for pediatric monitored anesthesia care for MRI, specifically identifying important patient demographics and looking at important outcomes including adverse events.
Detailed description
Patients will be randomized to either arm of the study. Throughout the sedation and recovery period, all study patients will have careful, routine documentation of hemodynamics (blood pressure, heart rate, plus oximeter, respiratory rate) as well as sedation depth. Patients will remain in recovery room until they have maintained discharge criteria for 30 minutes.
Interventions
DRUGDexmedetomidine
An initial bolus of 2 mcg/kg of dexmedetomidine will be administered over 10 minutes. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a 1.5 mcg/kg/hr infusion is initiated until the MRI is complete.
DRUGPropofol
An initial bolus of 1mg/kg of propofol will be administered over 1 minute. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a propofol infusion of 125 mcg/kg/min is initiated until the MRI is complete.
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Patient is 3 - 11 years * Patient is scheduled for MRI at Children's Hospital Boston. * Patient meets criteria to receive either dexmedetomidine or propofol sedation * Patient's guardian provides written consent
Exclusion criteria
* Patient does not meet established sedation criteria * Patient has history of allergy, intolerance, or reaction to dexmedetomidine or propofol or hypersensitivity * Patient has current, repaired, or risk for Moya-Moya disease * Patient has had a stroke within the past six months * Patient has uncontrolled hypertension * Patient currently uses beta antagonist, alpha 2 agonist or calcium blocker * Known soy, Lecithin, or egg allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events During the Sedation and Recovery Period | During sedation, recovery period and overnight, up to 24 hours | Adverse events will be described by type, system involvement and level of severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Parameters (Sedation Scales, Hemodynamic Variables, Clinical Observations) | During sedation, recovery and overnight, up to 24 hours | Sedation scores, mean arterial blood pressures, clinical observations during sedation and recovery period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexmedetomidine Group Dexmedetomidine given as 2mcg/kg bolus over 10 minutes followed by 1.5mcg/kg/hr infusion for duration of scan. The bolus may be repeated up to 2 times at any time during the sedation in the event that adequate sedation conditions (minimum Ramsay Sedation Score of 4) are not achieved. In the event that dexmedetomidine is unable to achieve motionless conditions, after a total of 3 boluses, 0.5 mg/kg IV pentobarbital may be administered at q1 minute intervals up to a maximum of 2 mg/kg, per established protocol.
Dexmedetomidine: An initial bolus of 2 mcg/kg of dexmedetomidine will be administered over 10 minutes. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a 1.5 mcg/kg/hr infusion is initiated until the MRI is complete. | 8 |
| Propofol Group Propofol bolus at an initial dose of 1 mg/kg over 1 minute then up to 2 additional 1 mg/kg boluses may be given (total 3 mg/kg) - each over 1 minute, wait 30 seconds after bolus completion to reassess sedation level. Once a minimum Ramsey Sedation Score 4 is achieved, an infusion at 125 mcg/kg/min is initiated. It may be titrated to 300 mcg/kg/min. If there is movement or awakening the patient may be rebolused with no more than 2 doses of Propofol at 1 mg/kg over 1 minute, in the same dosing manner as described above, waiting 30 seconds between doses. If adequate sedation is not achieved, 0.5 mg/kg IV pentobarbital may be administered at q1 minute intervals up to a maximum of 2 mg/kg.
Propofol: An initial bolus of 1mg/kg of propofol will be administered over 1 minute. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a propofol infusion of 125 mcg/kg/min is initiated until the MRI is complete. | 7 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 4 |
| Overall Study | No access to study drug in Pharmacy | 0 | 1 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Study drug had expired | 1 | 0 |
Baseline characteristics
| Characteristic | Dexmedetomidine Group | Propofol Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 8 Participants | 7 Participants | 15 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 8 participants | 7 participants | 15 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 4 / 8 | 4 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 |
Outcome results
Primary
Number of Adverse Events During the Sedation and Recovery Period
Adverse events will be described by type, system involvement and level of severity.
Time frame: During sedation, recovery period and overnight, up to 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexmedetomidine Group | Number of Adverse Events During the Sedation and Recovery Period | 4 Number of events |
| Propofol Group | Number of Adverse Events During the Sedation and Recovery Period | 5 Number of events |
Secondary
Clinical Parameters (Sedation Scales, Hemodynamic Variables, Clinical Observations)
Sedation scores, mean arterial blood pressures, clinical observations during sedation and recovery period
Time frame: During sedation, recovery and overnight, up to 24 hours
Population: Enrollment was slow and during enrollment for this study, a paper from Cincinnati Children Hospital Medical Center compared use of dexmedetomidine and propofol in children undergoing MRI, which answered most of the questions that this study wanted to address. With the publication of these results, the investigator decided to discontinue this study.