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Набор скоро начнётся NCT07371728

Effect of Aprepitant on Post-operative Nausea and Vomiting in Otologic Surgery

Фаза IV С лечением Otologic Disease

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: Aprepitant, Placebo.
Кому может быть актуально
Состояния в реестре: Otologic Disease. Базовые параметры: от 18 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
Канада
Следующий шаг
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Официальное название

Effect of Aprepitant on Post-operative Nausea and Vomiting in Otologic Surgery: A Pilot Randomized-Controlled Trial

Обзор

This project is being carried out to study the use of a medication to reduce nausea and vomiting after ear surgery.

Подробное описание

Post-operative nausea and vomiting (PONV) is one of the most common post-surgical complications and is associated with prolonged hospital stays, higher readmission rates, and heightened physical and emotional burden on patients and their families. While the general incidence of PONV is reported to be approximately 20-30% across all specialties, it may affect up to 60-80% of patients undergoing middle ear surgery. Indeed, surgical drilling and irrigation close to inner ear structures may stimulate the vestibular system and activate the chemoreceptor trigger zone and emetic center.

Aprepitant is a novel selective neurokinin-1 (NK1) antagonist which has been extensively studied for the prevention of chemotherapy-induced nausea and vomiting. Randomized controlled trials in gynecologic and open abdominal surgery have shown pre-operative oral aprepitant may provide benefit in reducing nausea and vomiting in the post-operative setting, even beyond commonly employed anti-emetics such as 5HT3 receptor antagonists4. While some authors have reported on its use in thyroid, facial plastics and transsphenoidal surgery, no trial to date has specifically investigated the use of pre-operative aprepitant as an adjunctive medication to reduce post-operative nausea and vomiting in patients undergoing middle ear surgery.

The hypothesis of this research project is that pre-operative aprepitant will provide the added benefit in reducing the incidence of post-operative nausea and vomiting in patients undergoing middle ear surgery when administered in conjunction with a 5-HT3 antagonist and dexamethasone.

Вмешательства

  • Препарат Aprepitant
    Participants will be randomly assigned to the intervention or control group in a 1:1 ratio. Oral aprepitant of 80mg will be administered within an hour of induction for an otological surgery.
  • Другое Placebo
    Participants will be randomly assigned to the intervention or control group in a 1:1 ratio. An oral placebo capsule will be administered within an hour of induction for an otological surgery.

Первичные конечные точки

  • Incidence of clinically important postoperative nausea and vomiting [Срок оценки: 6h to 48h postoperatively]

Критерии участия

Критерии включения

  • Adult patients undergoing middle ear surgery including tympanoplasty with or without ossicular chain reconstruction, tympanomastoidectomy or stapedectomy
  • Patient using a hormonal contraceptive will be included, but warned aprepitant may reduce the efficacy of hormonal contraception thus an alternative or backup contraceptive methods should be used for one month after surgery

Критерии исключения

  • Children (<18 years old)
  • Patients unable to complete the post-procedure questionnaire (either due to time constraints, neurocognitive impairment, etc.)
  • Patients taking concomitant medications that are substrates, inhibitors or inducers of CYP3A4 or CYP2CP that are at risk of having a clinically significant effect
  • Patients with a history of hypersensitivity reaction to any of the medications used in the study
  • Patients who are pregnant or breastfeeding
  • Patients unable to receive general anesthesia (i.e. procedures performed under local anesthesia with or without sedation)
  • Patients with severe hepatic insufficiency (Child-Pugh class C)
  • Patients on total intravenous anesthesia (TIVA)

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
Лечение

Центры проведения

Канада · 1 центр
  • Jewish General Hospital — Montreal

Идентификаторы

NCT: NCT07371728 · 2026-4646

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗