Status:
RECRUITING
Dexmedetomidine Versus Propofol Sedation for Drug-Induced Sleep Endoscopy in Pediatric Obstructive Sleep Apnea
Lead Sponsor:
Erin Kirkham
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
3-11 years
Phase:
PHASE2
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
October 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05303987
Start Date
October 5 2022
End Date
August 31 2026
Last Update
August 24 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109