Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea

Cincinnati Children's Hospital Medical Center

Status and phase: Completed; Phase 4

Conditions: Sleep Apnea, Obstructive

Treatments: Drug: Dexmedetomidine; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01344759

CCHMC 2009-0514

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 12 months to 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Propofol

Active Comparator group

Treatment:

Drug: Propofol

Dexmedetomidine

Active Comparator group

Treatment:

Drug: Dexmedetomidine