Comparing Safety and Efficacy of Dexmedetomidine and Propofol
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|ClinicalTrials.gov Identifier: NCT01152021|
Recruitment Status : Terminated (Publication of a similar study. Not ethical to continue.)
First Posted : June 29, 2010
Last Update Posted : July 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Safety and Efficacy of Sedation Medications||Drug: Dexmedetomidine Drug: Propofol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparing Safety and Efficacy of Dexmedetomidine and Propofol in Patients Requiring Sedation for MRI Scanning|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Active Comparator: 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.
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.
Other Name: Precedex
Active Comparator: Propofol Group
Propofol bolus at an initial dose of 1 mg/kg over 1 minute then up to two additional 1 mg/kg boluses may be administered (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.
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.
Other Name: Diprivan
- Number of adverse events during the sedation and recovery period as a measure of safety and tolerability. [ Time Frame: 6 - 8 months ]Adverse events will be described by type and level of severity.
- To compare propofol and dexmedetomidine with respect to clinical parameters (sedation scales, hemodynamic variables, clinical observations) [ Time Frame: 6 - 8 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01152021
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Randy Prescilla, MD||Boston Children’s Hospital|