Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea
Recruitment status was Recruiting
The purpose of this research study is to examine the effects of two commonly used anesthetic drugs, dexmedetomidine and propofol, have on the shape and muscle tone of the upper airway in children, adolescents, and young adults with a history of obstructive sleep apnea (OSA) having an MRI scan.
The results of this study will help in making the best decisions regarding the anesthesia medications that are most appropriate for children, adolescents, and young adults with OSA during MRI studies.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Increasing Depth of Dexmedetomidine and Propofol Anesthesia on Upper Airway Morphology in Children With History of Obstructive Sleep Apnea|
- Cross sectional area of the pharyngeal airway [ Time Frame: during MRI within first 10 minutes of scanning ] [ Designated as safety issue: No ]The primary outcome measures will be the cross sectional area of the pharyngeal airway of the patients measured at two levels (soft palate and base of the tongue).
- Patient obstructive index and airway maintenance until Recovery Room discharge [ Time Frame: during MRI and until Recovery Room discharge - approximately 30 - 250 minutes ] [ Designated as safety issue: No ](a) anteroposterior dimension and transverse dimension of the pharyngeal airway of the patients measured at two levels: soft palate and base of the tongue, (b) patient movement during scan,(c) episodes of low oxygen saturation(d) placement of adjunct airway such as oral/nasal airway, laryngeal mask airway or endotracheal tube, (e) examine the relationship between OSA severity and episodes of desaturation and artificial airway placement, (f) PACU discharge time (g) arterial blood pressure and heart rate relative to baseline following dexmedetomidine and propofol.
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||February 2012|
|Estimated Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Propofol||
Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
Other Name: Diprivan
|Active Comparator: Dexmedetomidine||
Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.
Other Name: Precedex
Patients with OSA are at risk for airway obstruction (a condition that makes it difficult to breath) during sedation and anesthesia. Dexmedetomidine and propofol are safe and effective drugs regularly used by anesthesiologists. These drugs are used to put patients to sleep for operations and certain studies like MRI scans. However, there have been no studies describing the effects these drugs have on the upper airway of children, adolescents, and young adults with OSA.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344759
|Contact: Mohamed Mahmoud, MD||513636 email@example.com|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Mohamed Mahmoud, MD 513-636-4408 firstname.lastname@example.org|
|Principal Investigator: Mohamed Mahmoud, MD|
|Principal Investigator:||Mohamed Mahmoud, MD||Children's Hospital Medical Center, Cincinnati|