Effect of Tegileridine Versus Sufentanil as Analgesic Components on Opioid-Induced Cough During Anesthesia Induction
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: Tegilerdine, Sufentanil.
- Кому может быть актуально
- Состояния в реестре: General Anesthetic Drug Adverse Reaction. Базовые параметры: 18 лет — 65 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 Affiliated Lianyungang Hospital of Xuzhou Medical University
Обзор
In patients undergoing general anesthesia with planned tracheal intubation , a prospective, randomized, controlled study was conducted to record the occurrence of cough 2 minutes after injection of Sufentanil or Tegilerdine. The cough was graded based on the frequency and duration: Grade I, no cough; Grade II, a single mild cough; Grade III, multiple coughs with duration \<1 second; Grade IV, continuous coughing with a duration \>15 seconds.
Подробное описание
Using a computer-generated randomized number table, patients were divided into two groups: the experimental group receiving Tiliglitidine (T group) at 20-50ug/kg, and the control group receiving Sufentanil (S group) at 0.2-0.4 μg/kg. After patients arrived in the operating room, routine monitoring including non-invasive blood pressure, electrocardiogram, and oxygen saturation was performed, and intravenous access was established. Patients were oxygenated and given the study drug before anesthesia induction. No other drugs were administered to the patients before giving the study drug. During anesthesia induction, patients received intravenous injection of Tiliglitide or Sufentanil according to their group. The severity of coughing was graded based on the number of coughing episodes: graded by the number and duration of coughs: Grade I, no cough, breathing regular; Grade II, a single mild cough; Grade III, multiple coughs, lasting less than 15 seconds; Grade IV, continuous coughs, lasting more than 15 seconds.
Вмешательства
- Препарат Tegilerdine
Inject Tegilerdine in the induction of general anesthesia - Препарат Sufentanil
Inject Sufentanil in the induction of general anesthesia
Первичные конечные точки
- Incidence of choking cough response [Срок оценки: 2 minutes after administration]
Вторичные конечные точки (4)
- Grading of choking and coughing response [Срок оценки: 2 minutes after administration]
- Blood pressure [Срок оценки: before injection of Tegilerdine or Sufentanil (T0), 2 minutes after injection (T1), 1 minute before intubation (T2), 1 minute after intubation (T3), and 3 minutes after intubation (T4）]
- Heart rate [Срок оценки: before injection of Tegilerdine or Sufentanil (T0), 2 minutes after injection (T1), 1 minute before intubation (T2), 1 minute after intubation (T3), and 3 minutes after intubation (T4）]
- Adverse reaction [Срок оценки: 2 minutes after administration]
Критерии участия
Критерии включения
- Age between 18 and 65 years, 18 ≤ BMI (kg/m²) ≤ 30;
- ASA grade I \~ III;
- Scheduled elective surgery under general anesthesia with tracheal intubation.
Критерии исключения
- Patients with chronic cough (cough lasting >8 weeks) or asthma;
- Patients with a history of allergy to the drugs used during the study;
- Patients with severe cardiovascular disease, intracranial lesions, eye lesions, or lung lesions.
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
- Двойное слепое
- Основная цель
- Другое
Центры проведения
Китай · 1 центр
- The Affiliated Lianyungang Hospital of Xuzhou Medical University — Lianyungang
Идентификаторы
NCT: NCT07323043 · KY-20250815003-01