Swap Anesthetic Versus Continuous Desflurane in Adults Undergoing Bariatric 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: Desflurane, Sevoflurane-Desflurane.
- Кому может быть актуально
- Состояния в реестре: Obesity, Bariatric Surgery. Базовые параметры: от 18 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
- Чили
- 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
Desflurane Versus Sevoflurane-Desflurane Swap in Adults Undergoing Bariatric Surgery: A Randomized Non-Inferiority Trial on Extubation Time
Обзор
This randomized, parallel-group, non-inferiority clinical trial aims to evaluate whether an anesthetic swap strategy consisting of sevoflurane followed by desflurane 30 minutes before the end of surgery is non-inferior to continuous desflurane anesthesia with respect to extubation time in adults undergoing elective laparoscopic bariatric surgery. Secondary outcomes include time to achieve a Patient State Index (PSi) greater than 80, time to achieve an Aldrete score of at least 8, incidence of postoperative nausea and vomiting, post-anesthesia care unit length of stay, and desflurane-related costs.
Подробное описание
Obesity is associated with an increased risk of postoperative respiratory complications, making rapid and safe anesthetic recovery particularly important in patients undergoing bariatric surgery. Desflurane provides rapid emergence because of its favorable pharmacokinetic profile but is associated with higher cost and greater environmental impact than sevoflurane.
This prospective, randomized, parallel-group, non-inferiority trial will compare two inhalational anesthetic strategies in adults undergoing elective laparoscopic bariatric surgery at Clínica Dávila. Participants will be randomly assigned in a 1:1 ratio to receive either continuous desflurane throughout the procedure or a swap strategy consisting of sevoflurane during most of the operation followed by desflurane beginning 30 minutes before surgical closure.
The primary outcome is extubation time, defined as the interval from discontinuation of inhaled anesthetic agents to removal of the endotracheal tube. Secondary outcomes include time to achieve a Patient State Index (PSi) greater than 80, time to achieve an Aldrete score of at least 8 in the post-anesthesia care unit, incidence of postoperative nausea and vomiting, length of stay in the post-anesthesia care unit, and desflurane-related costs. The study is designed to determine whether the swap anesthetic strategy is non-inferior to continuous desflurane while reducing desflurane consumption, with potential benefits for environmental sustainability and healthcare costs.
Вмешательства
- Препарат Desflurane
Desflurane administered as the inhalational anesthetic throughout the surgical procedure. - Препарат Sevoflurane-Desflurane
Sevoflurane administered during the initial phase of surgery followed by desflurane beginning 30 minutes before surgical closure.
Первичные конечные точки
- Extubation Time [Срок оценки: Perioperative]
Вторичные конечные точки (5)
- Time to Achieve Patient State Index Greater Than 80 [Срок оценки: Perioperative]
- Postoperative Nausea and Vomiting [Срок оценки: Up to 24 hours after surgery]
- Time to Achieve an Aldrete Score of at Least 8 [Срок оценки: Up to 24 hours after surgery]
- Time to Post-Anesthesia Care Unit Discharge Readiness [Срок оценки: Up to 24 hours after surgery]
- Desflurane-Related Cost [Срок оценки: Periprocedural (during surgery)]
Критерии участия
Критерии включения
- Age 18 years or older.
- Scheduled for elective laparoscopic gastric bypass surgery.
- Body mass index between 30 and 50 kg/m².
- American Society of Anesthesiologists physical status II or III.
- Able and willing to provide written informed consent.
Критерии исключения
- Surgical procedure lasting less than 2 hours.
- Body mass index greater than 50 kg/m².
- Significant cardiac disease.
- Moderate or severe obstructive respiratory disease, including uncontrolled asthma or chronic obstructive pulmonary disease.
- Pregnancy or breastfeeding.
- Known allergy or contraindication to medications used during the intraoperative period.
- Personal or family history of malignant hyperthermia.
- Active illicit drug use or substance dependence.
- Advanced chronic kidney disease, defined as an estimated glomerular filtration rate below 60 mL/min.
- Myasthenia gravis or another neuromuscular junction disorder.
- Severe cognitive or psychiatric disorder.
- Refusal to participate or withdrawal of informed consent at any time.
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
Чили · 1 центр
- Clínica Dávila — Santiago
Идентификаторы
NCT: NCT07748247 · CD2026/002