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Идёт набор NCT07556523

Patient Quality of Recovery After TAVR With Different Sedation Regimens

Фаза IV С лечением Transcatheter Aortic Valve Replacement (TAVR) Aortic Valve Stenosis

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, Dexmedetomidine, Midazolam, Fentanyl.
Кому может быть актуально
Состояния в реестре: Transcatheter Aortic Valve Replacement (TAVR), Aortic Valve Stenosis. 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
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Обзор

The goal of this clinical trial is to learn whether the type of sedation medication used during a transcatheter aortic valve replacement (TAVR) affects how people recover after the procedure. The main question this study aims to answer is whether different sedation regimens (propofol, dexmedetomidine, or midazolam with fentanyl) lead to differences in quality of recovery on the first day after the procedure. Researchers will compare three commonly used sedation medications (propofol, dexmedetomidine, or midazolam with fentanyl) to determine whether they lead to differences in recovery following a TAVR. Participants will: * Be enrolled before their scheduled TAVR procedure * Be randomly assigned to receive one of the three sedation medications during their procedure * Complete short surveys on postoperative days 1 and 7 about pain levels, how they feel during their recovery, and how satisfied they were with their anesthesia experience

Вмешательства

  • Препарат Propofol
    Propofol will be administered intravenously for intraoperative sedation during transcatheter aortic valve replacement (TAVR), with initiation and maintenance infusion dosing of 5-100 mcg/kg/min, titrated to clinical effect according to standard anesthesia practice.
  • Препарат Dexmedetomidine
    Dexmedetomidine will be administered intravenously for intraoperative sedation during transcatheter aortic valve replacement (TAVR), with initiation and maintenance infusion dosing of 0.2-1.0 mcg/kg/hr, titrated to clinical effect according to standard anesthesia practice.
  • Препарат Midazolam
    Midazolam will be administered intravenously for intraoperative sedation during TAVR and titrated to achieve adequate sedation and analgesia according to standard anesthesia practice.
  • Препарат Fentanyl
    Fentanyl will be administered intravenously for intraoperative sedation during TAVR and titrated to achieve adequate sedation and analgesia according to standard anesthesia practice.

Первичные конечные точки

  • Quality of Recovery on Postoperative Day 1 Measured by QoR-15 Survey [Срок оценки: From baseline assessment prior to transcatheter aortic valve replacement (TAVR) through postoperative day 1]
Вторичные конечные точки (12)
  • Heart Rate Change [Срок оценки: Intraoperative period through PACU admission]
  • Length of Stay [Срок оценки: From date of procedure through hospital discharge (up to 30 days after procedure date, whichever comes first)]
  • Patient Satisfaction with Anesthesia Measured by 5-Point Likert Scale [Срок оценки: Postoperative day 1 and postoperative day 7]
  • Pain Scores Measured by Visual Analog Scale (VAS) [Срок оценки: Upon post-anesthesia care unit (PACU) arrival (within ~2 hours after procedure), upon PACU discharge (~4 hours after procedure/medically cleared to leave PACU), on postoperative day 1, and postoperative day 7]
  • Quality of Recovery on Postoperative Day 7 Measured by QoR-15 Survey [Срок оценки: Postoperative day 7]
  • Cardiologist Operating Conditions Rating [Срок оценки: Immediately after completion of the TAVR procedure (intraoperative period)]
  • 30-Day Readmission Rates [Срок оценки: Within 30 days post-hospital discharge.]
  • Incidence of Hypotension Requiring Medical Intervention [Срок оценки: Intraoperative period]
  • Fluid Administration From Start of Procedure Through PACU Discharge [Срок оценки: From procedure start through post-anesthesia care unit discharge (~4 hours after procedure/medically cleared to leave PACU)]
  • Incidence of Intraoperative Bradycardia [Срок оценки: Intraoperative period]
  • Surgical Bleeding [Срок оценки: Intraoperative period]
  • Conversion to General Anesthesia [Срок оценки: Intraoperative period]

Критерии участия

Критерии включения

  • 18-90 years old, inclusive
  • Undergoing transfemoral TAVR under Monitored Anesthesia Care (MAC)
  • Speaks English or Spanish
  • Consents to participate

Критерии исключения

  • Preoperative heart rate < 50 bpm or arrhythmias (e.g., AFib with RVR)
  • Conduction abnormalities (e.g., 2nd/3rd degree AV block without pacer)
  • Allergy or contraindication to study drugs
  • Pulmonary artery pressure > 70mmHg
  • Morbid obesity BMI > 50
  • Pregnancy
  • 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
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Endeavor Health — Glenview

Идентификаторы

NCT: NCT07556523 · IRB2025-0154

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗