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

Launched by ERIN KIRKHAM · Mar 22, 2022

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ClinConnect Summary

This clinical trial is studying two different medications, dexmedetomidine and propofol, to see how they affect the airway during a special procedure called sleep endoscopy in children with obstructive sleep apnea (OSA). OSA is a condition where a child's breathing is interrupted during sleep, often due to blockages in the airway. The researchers want to find out if one medication is better than the other at helping doctors see how the airway collapses when the child is asleep. They are also looking to understand if the way the airway collapses at different levels can help predict if a child might still have OSA after undergoing a common surgery, called adenotonsillectomy, which removes the tonsils and adenoids.

To be part of this study, children aged 3 to 11 years must have been diagnosed with obstructive sleep apnea and be considered for the adenotonsillectomy surgery. They should have certain risk factors for ongoing sleep apnea after surgery. Parents or guardians need to be willing to sign a consent form and help fill out some questionnaires in English or Spanish. The study is currently recruiting participants, and it’s important for families to know that some children may not be eligible if they have had certain surgeries or have specific allergies. Participating in this trial will involve a sleep endoscopy procedure where doctors will observe how the child’s airway behaves under sedation.

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Eligibility 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
• • 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