Comparing two anesthetics for sleep endoscopy in children with sleep apnea
Trial of Dexmedetomidine Versus Propofol Sedation for Drug-Induced Sleep Endoscopy in Pediatric Obstructive Sleep Apnea
This study is testing which of two anesthetics works better during sleep endoscopy for kids with sleep apnea to see how it affects their airway and future treatment outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 3 Years to 11 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05303987 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effects of two anesthetics, dexmedetomidine and propofol, on airway collapse during drug-induced sleep endoscopy in children diagnosed with obstructive sleep apnea (OSA). The research will assess whether the level of airway collapse observed during the procedure correlates with persistent OSA after adenotonsillectomy, a common surgical treatment for this condition. By evaluating these anesthetics, the study seeks to improve understanding of their impact on airway dynamics in pediatric patients.
Who should consider this trial
Good fit: Ideal candidates are children diagnosed with obstructive sleep apnea who are surgical candidates for adenotonsillectomy and require sleep endoscopy due to risk factors for residual apnea.
Not a fit: Patients who do not have obstructive sleep apnea or are not candidates for adenotonsillectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better anesthetic choices for children undergoing procedures for obstructive sleep apnea, potentially improving surgical outcomes.
How similar studies have performed: While there have been studies on anesthetic effects in adults, this specific comparison in pediatric obstructive sleep apnea is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Erin Kirkham, MD MPH — University of Michigan
- Study coordinator: Brittany Nordhaus
- Email: nbrittan@med.umich.edu
- Phone: 734-232-1740
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.