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

Phase 2

Recruiting

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: Dexmedetomidine sedation; Drug: Propofol sedation

• Registration Number: NCT05303987
• Lead Sponsor: Erin Kirkham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Study Start: 2022-10-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14
• Primary Completion: 2026-08-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine sedation	Dexmedetomidine sedation	1 mcg/kg loading dose, then continue at an infusion of 1 mcg/kg/hour
Propofol sedation	Propofol sedation	2.5 mg/kg loading dose, then continue at an infusion of 250 mcg/kg/minute.

Primary Outcome Measures

Name	Time	Method
Mean obstruction score at the tongue base	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States