Trial Outcomes & Findings for Comparing Safety and Efficacy of Dexmedetomidine and Propofol (NCT NCT01152021)
NCT ID: NCT01152021
Last Updated: 2019-05-21
Results Overview
Adverse events will be described by type, system involvement and level of severity.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
15 participants
Primary outcome timeframe
During sedation, recovery period and overnight, up to 24 hours
Results posted on
2019-05-21
Participant Flow
Participant milestones
| Measure |
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.
|
Propofol Group
Propofol bolus of 1 mg/kg over 1 minute then up to two additional 1 mg/kg boluses may be given (total 3 mg/kg) - each over a one (1) minute interval, waiting 30 seconds after completion of each bolus 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 given 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.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
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.
|
Propofol Group
Propofol bolus of 1 mg/kg over 1 minute then up to two additional 1 mg/kg boluses may be given (total 3 mg/kg) - each over a one (1) minute interval, waiting 30 seconds after completion of each bolus 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 given 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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
4
|
|
Overall Study
Study drug had expired
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
No access to study drug in Pharmacy
|
0
|
1
|
Baseline Characteristics
Comparing Safety and Efficacy of Dexmedetomidine and Propofol
Baseline characteristics by cohort
| Measure |
Dexmedetomidine Group
n=8 Participants
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.
|
Propofol Group
n=7 Participants
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.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=93 Participants
|
7 participants
n=4 Participants
|
15 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: During sedation, recovery period and overnight, up to 24 hoursAdverse events will be described by type, system involvement and level of severity.
Outcome measures
| Measure |
Dexmedetomidine Group
n=8 Participants
Adverse events in subjects who received dexmedetomidine given bolus and infusion for duration of scan, with or without IV pentobarbital
|
Propofol Group
n=7 Participants
Adverse events in subjects who received propofol bolus and infusion with or without IV pentobarbital
|
|---|---|---|
|
Number of Adverse Events During the Sedation and Recovery Period
|
4 Number of events
|
5 Number of events
|
SECONDARY outcome
Timeframe: During sedation, recovery and overnight, up to 24 hoursPopulation: 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.
Sedation scores, mean arterial blood pressures, clinical observations during sedation and recovery period
Outcome measures
Outcome data not reported
Adverse Events
Dexmedetomidine Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Propofol Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dexmedetomidine Group
n=8 participants at risk
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.
|
Propofol Group
n=7 participants at risk
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 interval, 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.
|
|---|---|---|
|
Blood and lymphatic system disorders
hypotension
|
50.0%
4/8 • Number of events 4
|
42.9%
3/7 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
low pulse oximetry level
|
0.00%
0/8
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
cluster seizures
|
0.00%
0/8
|
14.3%
1/7 • Number of events 1
|
Additional Information
Rachel Dabek
Department of Anesthesia, Perioperative and Pain Medicine
Phone: 857-218-5413
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place