Clinical trial NCT01344759: Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea
Official title: Effect of Increasing Depth of Dexmedetomidine and Propofol Anesthesia on Upper Airway Morphology in Children With History of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Apnea, Obstructive
Keywords: Obstructive Sleep Apnea
MRI
Pediatrics
Dexmedetomidine
Propofol
Anesthesia
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Patients with documented history of OSA by polysomnography who require anesthesia for MRI sleep study or MRI brain imaging study.
2. Subjects must be 12 months to 25 years of age (inclusive)
3. 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:

1. 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).
2. The subject is allergic to or has a contraindication to propofol or dexmedetomidine.
3. The subject has a tracheostomy or other mechanical airway device
4. The subject is not scheduled to receive anesthesia-sedation care for the MRI
5. The subject has a history or a family (parent or sibling) history of malignant hyperthermia.

Primary outcomes:
measure: Cross Sectional Area of the Pharyngeal Airway
timeFrame: during MRI within first 10 minutes of scanning
Secondary outcomes:
measure: Obstructive Index Until Recovery Room Discharge
timeFrame: During MRI and until recovery room discharge - approximately 30-250 minutes
measure: Respiratory Disturbance Index
timeFrame: During MRI and until recovery room discharge - approximately 30-250 minutes
measure: Needed Artificial Airway
timeFrame: During MRI and until recovery room discharge - approximately 30-250 minutes
measure: Room Air SpO2
timeFrame: During MRI and until recovery room discharge - approximately 30-250 minutes
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Mohamed Mahmoud, MD
role: PRINCIPAL_INVESTIGATOR
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