Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea

Completed · Phase 4

Conditions studied: Sleep Apnea, Obstructive

In brief

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.

Key facts

Study ID

NCT01344759

Run by

Children's Hospital Medical Center, Cincinnati

People needed

60

Starts

2009-06-01

Expected to finish

2011-11-01

Last updated by the study team

2018-08-08

Who can join

Age: 1 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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