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NCT Number: NCT05303987

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

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.

Recruiting

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Key information

Age range

3 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Brittany Nordhaus

CONTACT

[email protected]

734-232-1740

Erin Kirkham, MD MPH

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.
  • 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 of age at the time of consent
  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Brittany Nordhaus

CONTACT

[email protected]

734-232-1740

Sponsors and collaborators

Lead sponsor

Erin Kirkham

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 31, 2022
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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