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

Last updated: March 12, 2025
Sponsor: Erin Kirkham
Overall Status: Active - Recruiting

Phase

2

Condition

Sleep Apnea Syndromes

Treatment

Propofol sedation

Dexmedetomidine sedation

Clinical Study ID

NCT05303987
HUM00207865
K23HL153897
  • Ages 3-11
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

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

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

  3. Clinical determination by the child's otolaryngologist surgeon that the child wouldbenefit from sleep endoscopy prior to adenotonsillectomy due to one or more reportedrisk factors for residual sleep apnea after surgery, which may include:

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

  5. Severe preoperative OSA (AHI ≥10 events/hour)

  6. Discordance between awake physical exam (eg. small tonsils) and sleep apneasymptoms or severity;

  7. African American race

  8. Age ≥7 years old

  9. Male or Female ages 3.00 - 11.99 years

  10. Parent/guardian ability to understand and willingness to sign a written informedconsent..

  11. Parent/guardian must understand/read/speak English or Spanish and be able andwilling to complete questionnaires.

Exclusion

Exclusion Criteria:

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

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

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

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

  5. Contraindication to receiving general anesthesia

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Propofol sedation
Phase: 2
Study Start date:
October 05, 2022
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

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