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Идёт набор NCT05577962

Opioid Free Anesthesia on the Quality of Early Recovery

Фаза IV С лечением Opioid-free Anesthesia

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: OFA group (group T).
Кому может быть актуально
Состояния в реестре: Opioid-free Anesthesia. Базовые параметры: 18 лет — 99 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
Китай
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

The Effect of Opioid-free Anesthesia Protocol on the Early Quality of Recovery After Thyroidectomy (TOFA Trial): Study Protocol for a Prospective, Monocentric, Randomized, Single-blinded Trial

Обзор

To analyze and compare the effect of OFA scheme and traditional balanced anesthesia scheme on QoR15 after thyroidectomy, and further clarify the safety and rationality of OFA scheme in perioperative application of thyroid surgery.

Подробное описание

OFA scheme (group T) was given dexamethasone 8mg for anti-inflammatory and antiemetic before operation, flurbiprofen axetil 50mg for preemptive analgesia, and dexmedetomidine was infused under ECG monitoring at an initial rate of 0.5 μ G/kg (more than 10min), then changed to 0.2ug/kg/h, and stopped infusion 20 minutes before operation closure. Before induction, lidocaine (1mg/kg), esketamine (0.5mg/kg), propofol (1-2mg/kg) and rocuronium (0.6mg/kg) were infused slowly, and endotracheal intubation was carried out when the anesthetic was fully effective and the BIS value was about 40. After successful intubation.During the operation, continuous propofol (BIS-guided) plus dexmedetomidine 0.2 μg/kg/h (stopped 20 min before skin closure) plus lidocaine 1 mg/kg/h was used to maintain the depth of anesthesia; The routine anesthesia group (Group C) was induced to give sufentanil 0.3-0.5ug/kg, propofol 1-2mg/kg, rocuronium 0.6mg/kg slowly, and then intubated when the anesthetic was fully effective and the BIS value was about 40. Remifentanil was continuously pumped 0.1-0.2ug/kg during operation min. Total intravenous propofol (BIS guided) plus a continuous remifentanil infusion at 0.1-0.2 μg/kg/min was used to maintain the depth of anesthesia.

Вмешательства

  • Препарат OFA group (group T)
    OFA scheme (group T) was given dexamethasone 8mg for anti-inflammatory and antiemetic before operation, flurbiprofen axetil 50mg for preemptive analgesia, and dexmedetomidine was infused under ECG monitoring at an initial rate of 0.5 μ G/kg (more than 10min), then changed to 0.2ug/kg/h, and stopped infusion 20 minutes before operation closure. Before induction, lidocaine (1mg/kg), esketamine (0.5mg/kg), propofol (1-2mg/kg) and rocuronium (0.6mg/kg) were infused slowly, and endotracheal intubatio

Первичные конечные точки

  • The QoR-15 score [Срок оценки: Hour 24 after surgery]
Вторичные конечные точки (8)
  • Postoperative VAS score [Срок оценки: Hour 24，Hour 48，Hour 72 after surgery]
  • Postoperative complication rate [Срок оценки: Hour 24，Hour 48，Hour 72 after surgery]
  • Opioid consumption [Срок оценки: Hour 24，Hour 48，Hour 72 after surgery]
  • Anesthesia related adverse events [Срок оценки: Hour 24，Hour 48，Hour 72 after surgery]
  • Postoperative fatigue, ICFS scores after surgery [Срок оценки: Hour 24，Hour 48，Hour 72 after surgery]
  • Postoperative mental state [Срок оценки: Hour 24，Hour 48，Hour 72 after surgery]
  • Incidence of chronic pain and quality of life [Срок оценки: 3 months after surgery]
  • the QoR-15 score 48,72 hours after surgery [Срок оценки: 48,72 hours after sugery]

Критерии участия

Критерии включения

  • Patients undergoing elective thyroidectomy under general anesthesia
  • >18 year old
  • The informed consent form has been signed
  • American Society of Anesthesiologists (ASA) anesthesia grade I - II

Критерии исключения

  • Long term use of opioids
  • Long term use of NSAIDs
  • Have a history of psychosis, epilepsy, preoperative anxiety, depression, and emotional management disorders
  • Patients with increased gastric contents reflux and respiratory tract aspiration
  • Operation time>3h
  • Severe liver and kidney insufficiency, cardiac insufficiency, bradycardia with 2 ° II or 3° atrioventricular block
  • Those who are allergic to or have contraindications to drugs that may be used in the test
  • Those who cannot cooperate with researchers

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • Beijing Friendship Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT05577962 · opioid-free anesthesia

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗