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Набор скоро начнётся NCT07639723

Aprepitant to Improve Same Day Discharge for TKA

Фаза IV С лечением PONV

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 Injection, Ondansetron (Zofran), Dexamethasone, Placebo.
Кому может быть актуально
Состояния в реестре: PONV. Базовые параметры: 18 лет — 90 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 →
Официальное название

Preoperative Aprepitant to Improve Same-Day Discharge After Total Knee Arthroplasty: A Randomized Double-Blind Placebo-Controlled Trial

Обзор

The purpose of this research is to study whether adding an FDA approved medication called aprepitant (a medication given to patients like you to reduce or eliminate nausea and vomiting) to the usual treatment to prevent nausea and vomiting given to patients during knee replacement surgery helps more patients go home on the same day of surgery (before midnight) by eliminating nausea and vomiting.

Подробное описание

This is a prospective, randomized, double-blind, placebo-controlled trial involving adults undergoing primary total knee arthroplasties at Endeavor Health SKH with presumed same-day discharge (as identified by the orthopedic surgery team prior to surgery). Patients will be randomly assigned to either receive 32 mg of intravenous (IV) preoperative aprepitant, in addition to the standard antiemetic protocol (4 mg IV dexamethasone after induction of MAC sedation anesthesia and 4 mg IV ondansetron at surgical closure), or the standard protocol with placebo (saline solution in same volume at the time aprepitant is given in the preoperative holding area by nursing). Aprepitant will be administered by the preoperative nurse in the holding area to ensure blinding of the anesthesia, surgical, and postoperative teams. All patients will receive either epidural or spinal anesthesia following our standard regional anesthesia protocol, with or without an adductor canal block. Intraoperatively, all patients will receive propofol infusions titrated to a RASS of 0 to -2 per the standard of care protocol at SKH. All patients will receive postoperative rescue antiemetics as needed and within the PACU admission order set choices for PONV.

Вмешательства

  • Препарат Aprepitant Injection
    32mg aprepitant will be administered intravenously preoperatively during single sided total knee arthroscopy
  • Препарат Ondansetron (Zofran)
    4 mg IV ondansetron will be given at surgical closure during total knee arthroscopy
  • Препарат Dexamethasone
    4 mg IV dexamethasone will be given after induction of MAC sedation anesthesia during total knee arthroscopy
  • Другое Placebo
    Patients will receive 32 mg of intravenous (IV) placebo preoperatively for a total knee arthroscopy

Первичные конечные точки

  • difference in the incidence of same-day discharges between two randomized groups of anti-emetic regimens for anesthesia care [Срок оценки: patients will be followed from arrival for surgery to 7 days post operatively]
Вторичные конечные точки (12)
  • Rescue antiemetics [Срок оценки: From date of admission to perioperative procedural area until hospital discharge or up to 30 days whichever is first]
  • Incidence of vomiting [Срок оценки: Upon post-anesthesia care unit (PACU) arrival (within ~2-3 hours after procedure), upon PACU discharge (~4-5 hours after procedure/medically cleared to leave PACU), admission to ASU directly after medically cleared from PACU to discharge from ASU]
  • patients with no PONV [Срок оценки: arrival at hospital to post op day 7]
  • Compare the incidence of PONV in PACU and ASU [Срок оценки: Upon post-anesthesia care unit (PACU) arrival (within ~2-3 hours after procedure), upon PACU discharge (~4-5 hours after procedure/medically cleared to leave PACU), admission to ASU directly after medically cleared from PACU to discharge from ASU]
  • Clinically important PONV [Срок оценки: Upon post-anesthesia care unit (PACU) arrival (within ~2-3 hours after procedure), upon PACU discharge (~4-5 hours after procedure/medically cleared to leave PACU), admission to ASU directly after medically cleared from PACU to discharge from ASU]
  • Readmission rates [Срок оценки: Discharge of hospital to 7 days post operatively]
  • Postoperative Delirium Measured by 4AT Assessment [Срок оценки: Preoperative baseline and upon PACU discharge (~4 hours after procedure/medically cleared to leave PACU).]
  • Compare APFEL Score [Срок оценки: Preoperatively in Holding area]
  • Compare length of stays between groups [Срок оценки: From date of procedure through hospital discharge (up to 30 days after procedure date, whichever comes first)]
  • opioid consumption [Срок оценки: From date of procedure through hospital discharge (up to 30 days after procedure date, whichever comes first)]
  • Patient Satisfaction [Срок оценки: post operative day 1 and 5]
  • Adverse Events [Срок оценки: These events will be assessed after immediate administration in the preoperative holding area and within 4 hours postoperatively]

Критерии участия

Критерии включения

  • Receiving primary, unilateral elective TKA with or without abductor canal block
  • Asa I-III
  • Age 18-90
  • Ability to receive ondansetron and dexamethasone
  • Ability to consent and complete surveys
  • English or Spanish speaking
  • Receiving regional anesthesia (epidural or spinal) for surgery

Критерии исключения

  • Allergy to any of the anti-emetics being administered
  • Current treatment of pimozide
  • Emergent surgery
  • Revision/ multiple revisions of TKA
  • Clinical suspicion of possible bowel obstruction
  • Need for general anesthesia
  • Pregnant/breast feeding
  • AST> 2.5 x the upper limit of normal or ALT> 2.5 x upper limit of normal, bilirubin> 1.5x upper limit of normal
  • Need for opioid or benzodiazepine antagonists
  • Not planned for same day discharge
  • Enrollment in a different drug trial for TKA
  • Unable to consent in English or Spanish

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
Тройное слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Endeavor Health Skokie Hospital — Skokie

Идентификаторы

NCT: NCT07639723 · IRB2026-0126

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗