Inhalational Versus Intravenous Anesthesia on Lung Injury After Major Surgery in Patients With Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 480
- 试验地点
- 1
研究概览
简要总结
This randomized controlled trial will compare the effects of intraoperative inhalational anesthesia versus intravenous anesthesia on postoperative lung injury in septic patients undergoing surgery. The primary goal is to determine if the choice of anesthetic technique influences the incidence or severity of this complication. Participants will be randomly assigned to one of the two anesthetic regimens during surgery. They will receive daily in-hospital assessments for lung injury and other outcomes and will be followed for clinical outcomes until 90 days after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Personnel responsible for participant recruitment, data collection, and outcome assessment, as well as the enrolled participants themselves, will be blinded to the group assignments. However, blinding of the intraoperative anesthesiologists is not feasible due to the visibly distinct nature of the two anesthesia regimes.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Diagnosis of sepsis according to Sepsis-3.0 (highly suspected or confirmed infection with acute increase in SOFA score ≥ 2).
- •Scheduled to undergo surgery under general aaesthesia for source control or sepsis-related operative management.
排除标准
- •Already intubated prior to entering the operating room.
- •Chronic home ventilator dependence (e.g., severe chronic obstructive pulmonary disease) before surgery.
- •Personal or family history of malignant hyperthermia.
- •Known allergy to ciprofol or sevoflurane.
- •Known allergy to egg or soy products.
- •Any contraindication to the planned anaesthetic agents.
- •Pregnant women.
研究者
Yang Zhao
Doctor
Sixth Affiliated Hospital, Sun Yat-sen University