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

Study Overview
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Brief Summary
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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.

Official Title
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Trial of Dexmedetomidine Versus Propofol Sedation for Drug-Induced Sleep Endoscopy in Pediatric Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: Propofol sedation
* Drug: Dexmedetomidine sedation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 6 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. Clinical determination by the child's otolaryngologist surgeon that the child would benefit from sleep endoscopy prior to adenotonsillectomy due to one or more reported risk factors for residual sleep apnea after surgery, which may include: Obese (>95th percentile of body mass index for age) Severe preoperative OSA (AHI ≥10 events/hour) Discordance between awake physical exam (eg. small tonsils) and sleep apnea symptoms or severity; African American race Age ≥7 years old Male or Female ages 3.00 - 11.99 years Parent/guardian ability to understand and willingness to sign a written informed consent.. Parent/guardian must understand/read/speak English or Spanish and be able and willing to complete questionnaires. Exclusion Criteria: 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. Contraindication to receiving general anesthesia

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol sedation<br>2.5 mg/kg loading dose, then continue at an infusion of 250 mcg/kg/minute. | Drug: Propofol sedation<br>* After induction with sevoflurane then Propofol will be initiated. If adequate sedation cannot be attained then a ketamine rescue can be given.<br>|
| Experimental: Dexmedetomidine sedation<br>1 mcg/kg loading dose, then continue at an infusion of 1 mcg/kg/hour | Drug: Dexmedetomidine sedation<br>* After induction with sevoflurane then Dexmedetomidine will be given. If adequate sedation cannot be attained then a ketamine rescue can be given.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean obstruction score at the tongue base | The degree of obstruction is scored on a 4-point scale as 0% (0), <50% (1), 50-99% (2), or 100% (3). Scores from the 3 surgeons will be averaged for use in analysis. | During Drug Induced Sleep Endoscopy (DISE) procedure, as judged subsequently by video review by the three raters | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-Induced Sleep Endoscopy, Propofol, Dexmedetomidine