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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Erin Kirkham
Study ID
NCT05303987
Phase
PHASE2
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
3 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Propofol sedation — DRUG
    After induction with sevoflurane then Propofol will be initiated. If adequate sedation cannot be attained then a ketamine rescue can be given.
  • Dexmedetomidine sedation — DRUG
    After induction with sevoflurane then Dexmedetomidine will be given. If adequate sedation cannot be attained then a ketamine rescue can be given.

Study Details

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.

Key Dates

Start date
Oct 5, 2022
Status verified
May 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Propofol sedation
    2.5 mg/kg loading dose, then continue at an infusion of 250 mcg/kg/minute.
  • Experimental: Dexmedetomidine sedation
    1 mcg/kg loading dose, then continue at an infusion of 1 mcg/kg/hour

Primary Outcome Measure

Mean obstruction score at the tongue base [ Time Frame: During Drug Induced Sleep Endoscopy (DISE) procedure, as judged subsequently by video review by the three raters ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Brittany Nordhaus
[email protected]
734-232-1740
Erin Kirkham, MD MPH (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan· Ann Arbor, MI

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