Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Effect of Increasing Depth of Dexmedetomidine and Propofol Anesthesia on Upper Airway Morphology in Children With History of Obstructive Sleep Apnea

Conditions
-----------------
Sleep Apnea, Obstructive

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with documented history of OSA by polysomnography who require anesthesia for MRI sleep study or MRI brain imaging study. Subjects must be 12 months to 25 years of age (inclusive) Either the subject (if subject's age is 18-25) or the subject's legally authorized representative has given written informed consent to participate in the study Exclusion Criteria: The subject has life-threatening medical conditions (American Society of Anesthesiologists Physical Status 4, 5 or 6). The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is. For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III). The subject is allergic to or has a contraindication to propofol or dexmedetomidine. The subject has a tracheostomy or other mechanical airway device The subject is not scheduled to receive anesthesia-sedation care for the MRI The subject has a history or a family (parent or sibling) history of malignant hyperthermia.

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br> | Drug: Propofol<br>* 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.<br>* Other names: Diprivan;|
| Active Comparator: Dexmedetomidine<br> | Drug: Dexmedetomidine<br>* 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.<br>* Other names: Precedex;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cross Sectional Area of the Pharyngeal Airway | 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. | during MRI within first 10 minutes of scanning | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obstructive Index Until Recovery Room Discharge | The Obstructive Index is a count of the obstructive apnea events per hour of sleep | During MRI and until recovery room discharge - approximately 30-250 minutes | 
| Respiratory Disturbance Index | The respiratory disturbance index is a count of respiratory disturbance events per hour of sleep. | During MRI and until recovery room discharge - approximately 30-250 minutes | 
| Needed Artificial Airway | This is the count of the number of patients who needed an artificial airway. | During MRI and until recovery room discharge - approximately 30-250 minutes | 
| Room Air SpO2 | The patient's oxygen saturation on room air. | During MRI and until recovery room discharge - approximately 30-250 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive Sleep Apnea, MRI, Pediatrics, Dexmedetomidine, Propofol, Anesthesia