Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea

Phase 4

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	-
Dexmedetomidine	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
Cross Sectional Area of the Pharyngeal Airway	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.

Secondary Outcome Measures

Name	Time	Method
Obstructive Index Until Recovery Room Discharge	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
Room Air SpO2	During MRI and until recovery room discharge - approximately 30-250 minutes	The patient's oxygen saturation on room air.
Respiratory Disturbance Index	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	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.