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Набор скоро начнётся NCT07112157

Efficacy of Oxalidine and Sufentanil in Strabismus Correction

Без фазы С лечением Strabismus Surgery

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: Oliceridine, Sulfentanil.
Кому может быть актуально
Состояния в реестре: Strabismus Surgery. Базовые параметры: 3 лет — 60 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
Список центров уточняется — проверьте первичный протокол.
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

Efficacy of Oxalidine and Sufentanil in Strabismus Correction: a Non Inferiority Trial

Обзор

The purpose of this study is to compare the anesthetic effect of oxalidine and sufentanil in strabismus surgery through a non inferiority test, including analgesic efficacy, intraoperative hemodynamic stability, postoperative recovery quality and the incidence of adverse reactions. . This study will provide a new evidence-based basis for the application of opioids in ophthalmic short surgery, and may improve the perioperative experience of patients.

Подробное описание

Since surgery involves fine manipulation of the ocular muscles, postoperative pain and oculocardiac reflex (OCR) are common clinical challenges. Therefore, anesthesia management should not only ensure adequate analgesia, but also minimize stress reactions and adverse reactions caused by surgical stimuli. At present, opioids such as sufentanil are widely used in the anesthesia scheme of such surgery because of its potent analgesia and stable hemodynamic characteristics. However, sufentanil may cause respiratory depression, postoperative nausea and vomiting (PONV) and other side effects, and its high lipid solubility may prolong the postoperative recovery time.

Oliceridine is a new selective μ - opioid receptor agonist. Compared with traditional opioids, it has the characteristics of biased activation of G protein pathway, which may provide effective analgesia and reduce the adverse reactions mediated by β - arrestin pathway (such as respiratory depression and gastrointestinal dysfunction). Recent studies have shown that oselidine has shown good safety and efficacy in postoperative analgesia, but its application in short ophthalmic surgery (such as strabismus correction) has not been fully explored.

Вмешательства

  • Препарат Oliceridine
    After entering the room, the patient was intravenously injected with oselidine at a dose of 0.08mg/kg during anesthesia induction
  • Препарат Sulfentanil
    After the patient entered the room, sufentanil was injected intravenously during anesthesia induction with a dose of 0.4 μ g/kg

Первичные конечные точки

  • Adequate rate of intraoperative analgesia [Срок оценки: From enrollment to the end of treatment at 1 day]
  • Success rate of initial insertion of laryngeal mask [Срок оценки: From enrollment to the end of treatment at 1 day]
Вторичные конечные точки (4)
  • Ocular Heart Reflex (OCR) incidence rate [Срок оценки: From enrollment to the end of treatment at 1 day]
  • Hemodynamic fluctuations [Срок оценки: From enrollment to the end of treatment at 1 day]
  • Respiratory inhibition: [Срок оценки: From enrollment to the end of treatment at 1 day]
  • Postoperative nausea and vomiting (PONV) (0-24h) [Срок оценки: From enrollment to the end of treatment at 1 day]

Критерии участия

Критерии включения

  • The patients to be treated with strabismus correction under general anesthesia are 3-60 years old, regardless of gender.

The American Society of anesthesiologists (ASA) classification is Ⅰ - Ⅱ. Patients or their guardians (for child patients) voluntarily participated in the trial and signed the informed consent form with informed consent.

Критерии исключения

  • Those who are allergic to oxalidine, sufentanil or any of the ingredients in their preparations.

Patients with severe heart, liver, kidney and other important organ dysfunction.

Have a history of epilepsy or central nervous system disease. Other opioid analgesics were used within 48 hours before operation. Pregnant or lactating women. Patients with mental disorders who are unable to cooperate to complete the test related assessment.

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
Четверное слепое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07112157 · HenanPPH-FNN3

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗