Dexmedetomidine Versus Propofol Sedation for Drug-Induced Sleep Endoscopy in Pediatric Obstructive Sleep Apnea

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3-11
SponsorErin Kirkham

About this trial

This research study is designed to learn, first, whether two anesthetics have different effects on collapse seen within the upper airway during sleep endoscopy. A second purpose is to learn whether collapse at several levels of the upper airway is associated with obstructive sleep apnea that persists after adenotonsillectomy, the surgery that removes the tonsils and adenoids.

Eligibility criteria

Qualifiers

Diagnosed with Obstructive sleep apnea (OSA) by the following criteria: Obstructive Apnea Index (OAI) ≥ 1 or Apnea Hypopnea Index (AHI) ≥ 1.5, confirmed on nocturnal, laboratory-based polysomnography within the previous 12 months scored using American Academy of Sleep Medicine pediatric criteria in an accredited sleep lab.

Considered to be a surgical candidate for adenotonsillectomy to treat OSA by an board-certified or board-eligible otolaryngologist.

Obese (>95th percentile of body mass index for age)

Severe preoperative OSA (AHI ≥10 events/hour)

Disqualifiers

Previous adenotonsillectomy or other upper airway surgery (including tracheostomy) with the exception of isolated adenoidectomy if it occurred >18 months prior to recruitment.

Major medical diagnosis that may be exacerbated by the study treatment, pose undue risk to the patient, or that may impact interpretation of study results

History of allergic reaction to or contraindication to receiving propofol, dexmedetomidine, ketamine or sevoflurane

Allergy to eggs, egg products, soybeans or soybean products.

Trial design

Treatments tested in this trial

  • Propofol sedation
  • Dexmedetomidine sedation

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Erin Kirkham

Lead sponsor

University of Michigan

Sponsor institution

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator