Идёт набор NCT05303987
Dexmedetomidine Versus Propofol Sedation for Drug-Induced Sleep Endoscopy in Pediatric Obstructive Sleep Apnea
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Propofol sedation, Dexmedetomidine sedation.
- Кому может быть актуально
- Состояния в реестре: Obstructive Sleep Apnea. Базовые параметры: 3 лет — 11 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Trial of Dexmedetomidine Versus Propofol Sedation for Drug-Induced Sleep Endoscopy in Pediatric Obstructive Sleep Apnea
Обзор
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.
Вмешательства
- Препарат Propofol sedation
After induction with sevoflurane then Propofol will be initiated. If adequate sedation cannot be attained then a ketamine rescue can be given. - Препарат Dexmedetomidine sedation
After induction with sevoflurane then Dexmedetomidine will be given. If adequate sedation cannot be attained then a ketamine rescue can be given.
Первичные конечные точки
- Mean obstruction score at the tongue base [Срок оценки: During Drug Induced Sleep Endoscopy (DISE) procedure, as judged subsequently by video review by the three raters]
Критерии участия
Критерии включения
- 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 of age at the time of consent
- 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.
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Диагностика
Центры проведения
США · 1 центр
- University of Michigan — Ann Arbor
Публикации
- Kirkham EM, Hoi K, Melendez JB, Henderson LM, Leis AM, Puglia MP 2nd, Chervin RD. Propofol versus dexmedetomidine during drug-induced sleep endoscopy (DISE) for pediatric obstructive sleep apnea. Sleep Breath. 2021 Jun;25(2):757-765. doi: 10.1007/s11325-020-02179-x. Epub 2020 Sep 2. PMID 32876805
- Mahmoud M, Jung D, Salisbury S, McAuliffe J, Gunter J, Patio M, Donnelly LF, Fleck R. Effect of increasing depth of dexmedetomidine and propofol anesthesia on upper airway morphology in children and adolescents with obstructive sleep apnea. J Clin Anesth. 2013 Nov;25(7):529-41. doi: 10.1016/j.jclinane.2013.04.011. Epub 2013 Oct 2. PMID 24096043
- Kandil A, Subramanyam R, Hossain MM, Ishman S, Shott S, Tewari A, Mahmoud M. Comparison of the combination of dexmedetomidine and ketamine to propofol or propofol/sevoflurane for drug-induced sleep endoscopy in children. Paediatr Anaesth. 2016 Jul;26(7):742-51. doi: 10.1111/pan.12931. Epub 2016 May 23. PMID 27212000
Идентификаторы
NCT: NCT05303987 · HUM00207865 · K23HL153897