Phase
Condition
Sleep Apnea Syndromes
Treatment
Propofol sedation
Dexmedetomidine sedation
Clinical Study ID
Ages 3-11 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosed with Obstructive sleep apnea (OSA) by the following criteria: ObstructiveApnea Index (OAI) ≥ 1 or Apnea Hypopnea Index (AHI) ≥ 1.5, confirmed on nocturnal,laboratory-based polysomnography within the previous 12 months scored using AmericanAcademy of Sleep Medicine pediatric criteria in an accredited sleep lab.
Considered to be a surgical candidate for adenotonsillectomy to treat OSA by anboard-certified or board-eligible otolaryngologist.
Clinical determination by the child's otolaryngologist surgeon that the child wouldbenefit from sleep endoscopy prior to adenotonsillectomy due to one or more reportedrisk 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 apneasymptoms 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 informedconsent..
Parent/guardian must understand/read/speak English or Spanish and be able andwilling to complete questionnaires.
Exclusion
Exclusion Criteria:
Previous adenotonsillectomy or other upper airway surgery (including tracheostomy)with the exception of isolated adenoidectomy if it occurred >18 months prior torecruitment.
Major medical diagnosis that may be exacerbated by the study treatment, pose unduerisk 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
Study Design
Connect with a study center
University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
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