Effects of Perioperative Hyperoxia Versus Normoxia on Pulmonary, Endothelial, and Inflammatory Biomarkers in Elective Laparoscopic Lower Abdominal Surgery
概览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Concentration of syndecan-1
概览
简要总结
This single-center randomized interventional study evaluated the biological effects of two perioperative oxygen strategies in adults undergoing elective laparoscopic lower abdominal surgery under standardized general anesthesia. Participants were assigned to receive either normoxia (FiO2 0.35) or hyperoxia (FiO2 0.80) after intubation and throughout the intraoperative period. The study assessed perioperative changes in circulating biomarkers related to pulmonary epithelial stress, endothelial glycocalyx injury, oxidative stress, and inflammation, together with blood gas and hemodynamic parameters. The study was completed before registration and is being registered retrospectively.
详细描述
Perioperative oxygen administration is widely used during general anesthesia, but the biological effects of liberal oxygen exposure remain uncertain. This randomized parallel-group study compared a normoxic strategy (FiO2 0.35) with a hyperoxic strategy (FiO2 0.80) in adult patients undergoing elective laparoscopic lower abdominal surgery. The assigned inspired oxygen fraction was initiated immediately after tracheal intubation and maintained intraoperatively under volume-controlled ventilation with otherwise standardized anesthetic management.
The primary objective was to compare perioperative changes in circulating biomarkers reflecting endothelial glycocalyx injury and inflammatory activation. Biomarkers assessed included syndecan-1, sialic acid, surfactant protein-A, ischemia-modified albumin, tumor necrosis factor-alpha, and total protein. Secondary assessments included arterial and venous blood gas variables, lactate, mean arterial pressure, and heart rate.
This study was completed before registry submission and is being entered retrospectively for transparency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 70 years
- •Scheduled for elective laparoscopic lower abdominal surgery
- •Expected surgery duration of at least 90 minutes
- •ASA physical status I to III
- •Body mass index 18.5 to 35 kg/m2
- •Planned management under standardized general anesthesia with volume-controlled ventilation
排除标准
- •Known chronic pulmonary disease, including chronic obstructive pulmonary disease or asthma requiring regular medication
- •Baseline peripheral oxygen saturation below 92% on room air
- •Significant cardiovascular instability
- •Severe hepatic or renal dysfunction
- •Active infection or systemic inflammatory disease
- •Use of systemic corticosteroids or immunosuppressive therapy
- •Pregnancy
- •Inability to provide informed consent
- •Anticipated difficult airway
- •Expected need for postoperative mechanical ventilation
研究组 & 干预措施
Normoxia
Intraoperative inspired oxygen fraction (FiO2) of 0.35 under standardized general anesthesia and volume-controlled ventilation.
干预措施: Perioperative Oxygen Strategy - Normoxia (Other)
Hyperoxia
Intraoperative inspired oxygen fraction (FiO2) of 0.80 under standardized general anesthesia and volume-controlled ventilation.
干预措施: Perioperative Oxygen Strategy-Hyperoxia (Other)
结局指标
主要结局
Concentration of syndecan-1
时间窗: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation
Serum syndecan-1 concentration measured in duplicate.
Concentration of sialic acid
时间窗: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation
Serum sialic acid concentration measured in duplicate.
Concentration of surfactant protein-A
时间窗: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation
Serum surfactant protein-A concentration measured in duplicate.
Concentration of ischemia-modified albumin
时间窗: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation
Serum ischemia-modified albumin concentration measured in duplicate.
Concentration of TNF-alpha
时间窗: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation
Serum TNF-alpha concentration measured in duplicate.
Concentration of total protein
时间窗: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation
Serum total protein concentration measured in duplicate.
次要结局
- Intraoperative heart rate(Immediately after intubation and every 15 minutes up to 90 minutes)
- Arterial pH(10 minutes after establishment of assigned oxygen fraction)
- Arterial oxygen tension (PaO2)(10 minutes after establishment of assigned oxygen fraction)
- Intraoperative mean arterial pressure(Immediately after intubation and every 15 minutes up to 90 minutes)
- Arterial carbon dioxide tension (PaCO2)(10 minutes after establishment of assigned oxygen fraction)
- Venous oxygen tension (PvO2)(10 minutes after establishment of assigned oxygen fraction)
- Venous carbon dioxide tension (PvCO2)(10 minutes after establishment of assigned oxygen fraction)
- Arterial oxygen saturation (SaO2)(10 minutes after establishment of assigned oxygen fraction)
- Venous oxygen saturation (SvO2)(10 minutes after establishment of assigned oxygen fraction)
- Arteriovenous oxygen difference(10 minutes after establishment of assigned oxygen fraction)
- Lactate concentration(10 minutes after establishment of assigned oxygen fraction)
研究者
Nuzhet Mert Senturk, MD, Prof
Prof. Dr. Nuzhet Mert Senturk
Istanbul University