Comparing Safety and Efficacy of Dexmedetomidine and Propofol
This study is currently recruiting participants.
Verified September 2012 by Children's Hospital Boston
Sponsor:
Children's Hospital Boston
Information provided by (Responsible Party):
Randy Prescilla, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01152021
First received: June 25, 2010
Last updated: September 14, 2012
Last verified: September 2012
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | June 25, 2010 | ||||||||
| Last Updated Date | September 14, 2012 | ||||||||
| Start Date ICMJE | August 2011 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Number of adverse events during the sedation and recovery period as a measure of safety and tolerability. [ Time Frame: 6 - 8 months ] [ Designated as safety issue: Yes ] Adverse events will be described by type and level of severity. |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01152021 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
To compare propofol and dexmedetomidine with respect to clinical parameters (sedation scales, hemodynamic variables, clinical observations) [ Time Frame: 6 - 8 months ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Comparing Safety and Efficacy of Dexmedetomidine and Propofol | ||||||||
| Official Title ICMJE | Comparing Safety and Efficacy of Dexmedetomidine and Propofol in Patients Requiring Sedation for MRI Scanning | ||||||||
| 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. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
| Condition ICMJE | MRI Sedation | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 192 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 3 Years to 11 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01152021 | ||||||||
| Other Study ID Numbers ICMJE | 09-05-0250 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Randy Prescilla, Children's Hospital Boston | ||||||||
| Study Sponsor ICMJE | Children's Hospital Boston | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Children's Hospital Boston | ||||||||
| Verification Date | September 2012 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||