Inhalational Versus Intravenous Anesthesia on Postoperative Lung Injury in Septic Patients Undergoing Surgery
2026年5月15日 更新者：Yang Zhao、Sixth Affiliated Hospital, Sun Yat-sen University
Inhalational Versus Intravenous Anesthesia on Lung Injury After Major Surgery in Patients With Sepsis
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.
研究概览
研究类型
介入性
注册 (估计的)
480
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Yang Zhao
- 电话号码：0086-13802435520
- 邮箱：zhaoy47@mail.sysu.edu.cn
学习地点
-
-
Guangdong
-
Guangzhou、Guangdong、中国、510655
- The Sixth Affiliated Hospital of Sun Yat-sen University
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：inhalation group
|
The inhalation group will be maintained with inhaled sevoflurane and a continuous intravenous infusion of remifentanil.
|
|
实验性的：intravenous group
|
The intravenous group will be maintained with continuous intravenous infusions of both ciprofol and remifentanil.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Ventilator-free days at 7 days after surgery
大体时间：From the surgery to the 7th day
|
From the surgery to the 7th day
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
90-day overall survival
大体时间：90-day after surgery
|
90-day after surgery
|
|
Incidence of Sepsis-Associated Lung Injury at 7 days
大体时间：7-day after surgery
|
7-day after surgery
|
|
All-cause mortality at 7, 14 and 28 days after surgery
大体时间：7-day, 14-day and 28-day after surgery
|
7-day, 14-day and 28-day after surgery
|
|
Ventilator-free days at days 14 and 28 after surgery
大体时间：14-day, 28-day after surgery
|
14-day, 28-day after surgery
|
|
Organ-failure-free at days 7, 14 and 28
大体时间：7-day, 14-day, 28-day after surgery
|
7-day, 14-day, 28-day after surgery
|
|
Days alive out of hospital at day 28
大体时间：28-day after surgery
|
28-day after surgery
|
|
Days out of the intensive care unit at day 28
大体时间：28-day after surgery
|
28-day after surgery
|
|
Incidence of postoperative acute kidney injury
大体时间：7-day after surgery
|
7-day after surgery
|
|
Major adverse renal events at day 28
大体时间：28-day after surgery
|
28-day after surgery
|
|
Oxygenation index （PaO₂/FiO₂ ratio）
大体时间：Baseline before surgery, immediately after surgery, and once daily thereafter until tracheal extubation
|
Baseline before surgery, immediately after surgery, and once daily thereafter until tracheal extubation
|
|
Postoperative pulmonary complications
大体时间：7-day, 28-day after surgery
|
7-day, 28-day after surgery
|
|
Quality of life (EQ-5D-5L) and functional status (ADL)
大体时间：preoperatively, and on postoperative days 7, 28, 90
|
preoperatively, and on postoperative days 7, 28, 90
|
|
Adverse event
大体时间：28 days after surgery
|
28 days after surgery
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月15日
初级完成 (估计的)
2030年12月30日
研究完成 (估计的)
2030年12月30日
研究注册日期
首次提交
2026年1月30日
首先提交符合 QC 标准的
2026年5月15日
首次发布 (实际的)
2026年5月22日
研究记录更新
最后更新发布 (实际的)
2026年5月22日
上次提交的符合 QC 标准的更新
2026年5月15日
最后验证
2025年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.