The Effect of Remimazolam Versus Propofol on Postoperative Extubation Time
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: Remimazolam, propofol.
- Кому может быть актуально
- Состояния в реестре: Laparoscopic Hepatectomy. Базовые параметры: 18 лет — 80 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 Remimazolam Versus Propofol on Postoperative Extubation Time in Patients Undergoing Laparoscopic Hepatectomy: A Randomized Controlled Trial
Обзор
This clinical trial aims to help us understand how two drugs, Propofol and Remazoloam, affect when researchers remove a Participants' breathing tube after liver surgery (laparoscopic liver resection).The main research questions include: comparing the time to breathing tube removal between patients who receive each drug, comparing changes in heart rate and blood pressure during surgery, and comparing the rates of unwanted medical events after surgery. Researchers will give either Propofol or Remimazolam as a sedative medicine for anesthesia. This will allow the researchers to compare the time to breathing tube removal after surgery. Participants will complete their surgery according to a pre-planned surgical plan.
Подробное описание
This study is a clinical randomized controlled trial aimed at comparing the postoperative extubation time of remimazolam versus propofol in patients undergoing laparoscopic liver resection. Additionally, the study will compare intraoperative hemodynamic parameters, the incidence of adverse events during the anesthesia emergence period, length of stay in the post-anesthesia care unit (PACU), hospital length of stay, and the incidence of postoperative complications. Patients meeting the inclusion criteria will sign informed consent forms and be randomly assigned to one of two groups. Routine preoperative preparation will be performed. After entering the operating room, anesthesia induction and maintenance will be carried out according to the study protocol. After surgery, all patients will be transferred to the PACU. Extubation will be performed when extubation criteria are met, and patients will be returned to the ward when the Steward recovery score reaches ≥4. Data on postoperative extubation time, PACU stay, hospital length of stay, and postoperative complications will be recorded. Finally, data analysis and results reporting will be conducted.This trial can provide meaningful references for clinical drug selection. At the same time, this study will fill the gaps in clinical evidence in this field.
Вмешательства
- Препарат Remimazolam
Anesthesia induction: Intravenous injection of remimazolam 0.2-0.4 mg/kg. Anesthesia maintenance: Continuous infusion of remimazolam at 0.4-0.7mg/kg/h. - Препарат propofol
Anesthesia induction: Intravenous injection of propofol 1.5-2.5 mg/kg. Anesthesia maintenance: Continuous infusion of propofol at 4-10 mg/kg/h.
Первичные конечные точки
- Extubation time (minutes) [Срок оценки: From the time of cessation of intravenous sedative infusion until the time of tracheal extubation, up to 24 hours postoperatively.]
Вторичные конечные точки (8)
- Incidence of Adverse Events During Anesthesia Emergence (per patient) [Срок оценки: From the time of cessation of continuous intravenous sedative infusion until the time of PACU discharge, up to 24 hours postoperatively.]
- PACU Length of Stay (minutes) [Срок оценки: From the time of PACU admission until the time of PACU discharge, up to 24 hours postoperatively.]
- Postoperative Hospital Stay (days) [Срок оценки: From the time of the end of surgery until the time of hospital discharge, up to 30 days postoperatively.]
- Incidence of Postoperative Complications (per patient) [Срок оценки: From the time of the end of surgery until the time of hospital discharge, up to 30 days postoperatively.]
- Mean Arterial Pressure (mmHg) [Срок оценки: From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.]
- Heart Rate (bpm) [Срок оценки: From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.]
- Stroke Volume Variation (%) [Срок оценки: From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.]
- Cardiac Index (L/min/m²) [Срок оценки: From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.]
Критерии участия
Критерии включения
- 1): Planned to undergo laparoscopic hepatectomy.
2): Has signed the informed consent form.
3): Aged 18 to 80 years.
4): Body Mass Index (BMI) ranging from 18 to 28 kg/m².
5): American Society of Anesthesiologists (ASA) physical status classification I to III.
Критерии исключения
- 1）: Severe cardiopulmonary dysfunction, or hepatic/renal dysfunction.
2）: Diagnosis of neuropsychiatric disorders.
3）: Pregnant or lactating women.
4）: A history of allergy or contraindication to benzodiazepines, propofol, or any of their components.
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
- Другое
Центры проведения
Китай · 1 центр
- The First Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
Идентификаторы
NCT: NCT07611344 · IRB[2025]680