Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01344759|
Recruitment Status : Completed
First Posted : April 29, 2011
Results First Posted : February 23, 2016
Last Update Posted : March 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive||Drug: Dexmedetomidine Drug: Propofol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Increasing Depth of Dexmedetomidine and Propofol Anesthesia on Upper Airway Morphology in Children With History of Obstructive Sleep Apnea|
|Study Start Date :||June 2009|
|Primary Completion Date :||November 2011|
|Study Completion Date :||November 2011|
|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
- Cross Sectional Area of the Pharyngeal Airway [ Time Frame: during MRI within first 10 minutes of scanning ]The primary outcome measures will be the cross sectional area of the pharyngeal airway of the patients measured at two levels soft palate (nasopharyngeal) and base of the tongue (retroglossal). Magnetic resonance images of the airway were obtained during low (1 mcg/kg/hr) and high (3 mcg/kg/hr) doses of DEX or low (100 mcg/kg/m) and high (200 mcg/kg/m) doses of Propofol. All were administered through an intravenous (IV) catheter.
- Obstructive Index Until Recovery Room Discharge [ Time Frame: During MRI and until recovery room discharge - approximately 30-250 minutes ]The Obstructive Index is a count of the obstructive apnea events per hour of sleep
- Respiratory Disturbance Index [ Time Frame: During MRI and until recovery room discharge - approximately 30-250 minutes ]The respiratory disturbance index is a count of respiratory disturbance events per hour of sleep.
- Needed Artificial Airway [ Time Frame: During MRI and until recovery room discharge - approximately 30-250 minutes ]This is the count of the number of patients who needed an artificial airway.
- Room Air SpO2 [ Time Frame: During MRI and until recovery room discharge - approximately 30-250 minutes ]The patient's oxygen saturation on room air.
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): NCT01344759
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Mohamed Mahmoud, MD||Children's Hospital Medical Center, Cincinnati|