Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea



Status:Completed
Conditions:Insomnia Sleep Studies, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any - 25
Updated:8/10/2018
Start Date:June 2009
End Date:November 2011

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

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.

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.

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.
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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