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Dexmedetomidine vs Propofol Sedation for Pediatric Obstructive Sleep Apnea

Phase 2

Recruiting

Led By Erin Kirkham, MD MPH

Research Sponsored by Erin Kirkham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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.

Must not have

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

Contraindication to receiving general anesthesia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during drug induced sleep endoscopy (dise) procedure, as judged subsequently by video review by the three raters

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of two anesthetics on upper airway collapse during sleep endoscopy in children with sleep apnea.

Who is the study for?

This trial is for children aged 3 to under 12 with obstructive sleep apnea confirmed by a sleep study. They should benefit from a sleep endoscopy before tonsil and adenoid removal surgery, especially if they are obese, have severe OSA, small tonsils but severe symptoms, are African American or over 7 years old. Kids who've had previous upper airway surgeries or have certain medical risks or allergies can't participate.

What is being tested?

The study compares the effects of two sedatives—Dexmedetomidine and Propofol—during drug-induced sleep endoscopy in kids with obstructive sleep apnea. It aims to see how each drug affects airway collapse during the procedure and if this relates to persistent OSA after surgery.

What are the potential side effects?

Possible side effects include reactions specific to Dexmedetomidine such as low blood pressure, slow heart rate, dry mouth; and for Propofol: pain at injection site, low blood pressure, fast or slow heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am eligible for surgery to treat sleep apnea, as confirmed by an ear, nose, and throat doctor.

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I have been diagnosed with sleep apnea based on a sleep study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to or cannot take certain anesthesia drugs.

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I cannot have general anesthesia due to health risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during drug induced sleep endoscopy (dise) procedure, as judged subsequently by video review by the three raters

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during drug induced sleep endoscopy (dise) procedure, as judged subsequently by video review by the three raters

This trial's timeline: 3 weeks for screening, Varies for treatment, and during drug induced sleep endoscopy (dise) procedure, as judged subsequently by video review by the three raters for reporting.