Recruiting
Phase 2

Dexmedetomidine vs. Propofol

Sponsor:

Erin Kirkham

Code:

NCT05303987

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 3 - 11

Healthy Volunteers: Not accepted

Interventions

Propofol sedation

Dexmedetomidine sedation

Study Details

Brief 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.

Conditions

Obstructive Sleep Apnea

Study ID

NCT05303987

Start date

Oct 5, 2022

Status verified date

May, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 11

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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.
2. Considered to be a surgical candidate for adenotonsillectomy to treat OSA by an board-certified or board-eligible otolaryngologist.
3. 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:

1. Obese (>95th percentile of body mass index for age)
2. Severe preoperative OSA (AHI ≥10 events/hour)
3. Discordance between awake physical exam (eg. small tonsils) and sleep apnea symptoms or severity;
4. African American race
5. Age ≥7 years old
4. Male or Female ages 3.00 - 11.99 years of age at the time of consent
5. Parent/guardian ability to understand and willingness to sign a written informed consent..
6. Parent/guardian must understand/read/speak English or Spanish and be able and willing to complete questionnaires.

Exclusion Criteria:

1. Previous adenotonsillectomy or other upper airway surgery (including tracheostomy) with the exception of isolated adenoidectomy if it occurred >18 months prior to recruitment.
2. 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
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

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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

Interventions

Propofol sedation

After induction with sevoflurane then Propofol will be initiated.

If adequate sedation cannot be attained then a ketamine rescue can be given.

Dexmedetomidine sedation

After induction with sevoflurane then Dexmedetomidine will be given.

If adequate sedation cannot be attained then a ketamine rescue can be given.

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 and Locations

Central contacts

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Erin Kirkham, MD MPH

More Information

Sponsor

Erin Kirkham

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • Drug-Induced Sleep Endoscopy
  • Propofol
  • Dexmedetomidine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Erin Kirkham on 2026-05-14.