Opioid-Free Combined Anesthesia With Spontaneous Breathing for VATS
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: opioid based strategy, opioid-free strategy, Laryngeal mask airway; Preserved spontaneous breathing, Double lumen tracheal tube; Mechanical ventilation.
- Кому может быть актуально
- Состояния в реестре: Video-assisted Thoracoscopic Lung Surgery；Anesthesia. Базовые параметры: 18 лет — 70 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
Opioid-Free Combined Anesthesia Under Spontaneous Breathing for Video-Assisted Thoracoscopic Surgery of Pulmonary Nodules: A Multicenter, Open-Label, Randomized Controlled, 2x2 Factorial Design Clinical Study
Обзор
Non-tracheal intubated combined anesthesia with preserved spontaneous breathing significantly enhances the quality and speed of recovery post-VATS for patients undergoing lung nodule surgery. The "opioid-sparing strategy," which substitutes ketamine for opioids during surgery, not only provides effective analgesia but also protects perioperative lung function and reasonably prevents the occurrence of opioid-related adverse reactions; it also reduces medical costs and shortens the average hospital stay. However, the degree of benefit to patients lacks high-level clinical evidence. This study aims to comprehensively assess the effect of opioid-free combined anesthesia with preserved spontaneous breathing for VATS lung nodule surgery on postoperative rapid recovery from multiple aspects including postoperative lung function and pulmonary complications, pain, gastrointestinal function, nausea/vomiting, cognitive function, and depression/anxiety, intending to expand the dataset and application prospects in this field, and increase feasibility experience.
Подробное описание
This study is a prospective, multicenter, randomized controlled, open-label, 2x2 factorial design trial involving two types of interventions: ventilation methods (2 levels: preserved spontaneous breathing, mechanical ventilation) and combined anesthesia methods (2 levels: opioid-free combined anesthesia, opioid-based combined anesthesia). To evaluate the clinical efficacy and safety of these two types of interventions, four parallel groups of patients undergoing video-assisted thoracoscopic surgery for pulmonary nodules under different anesthesia strategies were established: preserved spontaneous breathing and opioid-based combined anesthesia (OSB group), preserved spontaneous breathing and opioid-free combined anesthesia (KSB group), double-lumen endotracheal tube mechanical ventilation and opioid-based combined anesthesia (OMV group), and double-lumen endotracheal tube mechanical ventilation and opioid-free combined anesthesia (KMV group). This study will be conducted in the thoracic surgical centers of six hospitals in China, carried out by experienced senior anesthetists and thoracic surgeons. Patients undergoing anesthesia in this study will experience three observation phases. Phase 1 (perioperative phase, day 0 to day 2): Observing the lung function status and the occurrence of adverse events under different anesthesia plans during the perioperative period; Phase 2 (postoperative hospital stay, day 3 to day 7): Observing the lung function status and the occurrence of adverse events under different anesthesia plans during the hospital stay; Phase 3 (short-term follow-up, day 8 to day 30): Observing the lung function status and the occurrence of adverse events under different anesthesia plans during the short-term follow-up period.
Вмешательства
- Препарат opioid based strategy
Induction and maintenance of anesthesia with opioids - Препарат opioid-free strategy
Esketamine was used for induction and maintenance of anesthesia - Процедура Laryngeal mask airway; Preserved spontaneous breathing
The patient used a laryngeal mask to maintain spontaneous breathing - Процедура Double lumen tracheal tube; Mechanical ventilation
The patient was mechanically ventilated using a double-lumen tracheal catheter
Первичные конечные точки
- Lung function 30 days after surgery [Срок оценки: 30 days after surgery]
Вторичные конечные точки (12)
- Intraoperative respiratory parameters [Срок оценки: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation]
- Intraoperative respiratory parameters [Срок оценки: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation]
- Intraoperative respiratory parameters [Срок оценки: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation]
- Intraoperative respiratory parameters [Срок оценки: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation]
- Intraoperative respiratory parameters [Срок оценки: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation]
- Perioperative stage indicators [Срок оценки: At the end of the operation]
- Perioperative stage indicators [Срок оценки: At the end of the operation]
- Postoperative pain [Срок оценки: Six hours, 24 hours, 48 hours after surgery]
- Postoperative Lung function [Срок оценки: 1, 3, 5 days after surgery]
- Postoperative Lung function [Срок оценки: 1, 3, 5 days after surgery]
- Postoperative pulmonary complications [Срок оценки: 1, 3, 5 days after surgery]
- Postoperative gastrointestinal function [Срок оценки: Six hours, 24 hours, 48 hours after surgery]
Критерии участия
Критерии включения
- ASA grades 1-2
- Age > 18 years and < 70 years
- Male or female patients
- VATS pulmonary nodule operation is planned under general anesthesia
- Voluntarily participate in the study and sign the informed consent
Критерии исключения
- Subject's operation is aborted
- Serious adverse events, complications or special physiological changes during the perioperative period should not be continued
- Expansion of surgical scope: resection of complex lung segment or complex lung lobectomy, thoracoscopic assisted small-incision surgery with enlarged incision, requiring pulmonary blood Tracheoplasty or bronchoplasty, partial pericardiectomy or conversion to thoracotomy
- Those who need a second operation within a month
- The patient or his/her guardian requests to withdraw on his/her own
- Reasons why other researchers think the study needs to be discontinued
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
- Открытое
- Основная цель
- Профилактика
Центры проведения
Китай · 1 центр
- Tongji Hospital — Ухань
Идентификаторы
NCT: NCT06367218 · S036