Safety and Efficacy of Intravenous (IV) Dexmedetomidine During Flexible Bronchoscopy and Endobronchial Ultrasound
To achieve safe,consistent, continuous sedation using Dexmedetomidine in advaced bronchoscopy procedures that may reduce the need for rapid pain sedative infusion.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Safety and Efficacy of Intravenous Dexmedetomidine Infusion During Flexible Bronchoscoy and Endobronchical Ultrasound|
- Achieve safe, consistent, continous moderate sedation using Dexmedetomidine in advanced bronchoscopy procedures, alleviating the need for rapid sedative infusion. [ Time Frame: at conclusion of subject enrollemtn ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
No Intervention: 1
Subjects randomized to arm 1 of the study will recieve standard of care conscious sedation for EBUS; midasolam and or fentanyl.
Active Comparator: 2
Subjects undergoing EBUS randomized to arm 2 of the study will recieve demedetomadine hydrochloride plus standard of care conscious sedation
Drug: dexmedetomidine hydrochloride
Dose of 0.4ug/kg/hr to 1.5ug/kg/hr to achieve a RASS score of -1 to-3 during the bronchoscopy procedure. Dexmedetomidine will infused a half hour before the proceudure is started and will continue throughout the procedure. Traditional sedatives (midazolam and or fentanyl) will be given prn.
Other Name: Precedex
Dexmedetomidine hydrochloride as a single agent produces sedation, pain relief, anxiety redution, stable respiratory rates, and predictable cardiovascular responses. Dexmedetomidine facilitates patient comfort, compliance and comprehension by offering sedation with the ability to awaken patients. This study is being done to determine sedation efficacy and dosing; measure reduction or eliminate the need for rapid sedative infusion during bronchoscopy; improvement of patient comfort and safety during complex bronchoscopy; establish a new paradigm for moderate sedation during flexible bronchoscopy
|United States, Massachusetts|
|Burlington, Massachusetts, United States, 01805|
|Principal Investigator:||David R Riker, MD||Lahey Clinic Medical Center|