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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
76
Normoxia arm: FiO2 0.35 Intervention started immediately after intubation and maintained intraoperatively
Hyperoxia arm: FiO2 0.80 Intervention started immediately after intubation and maintained intraoperatively
Istanbul University, Istanbul Faculty of Medicine
Istanbul, Turkey (Türkiye)
Concentration of syndecan-1
Serum syndecan-1 concentration measured in duplicate.
Time frame: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation
Concentration of sialic acid
Serum sialic acid concentration measured in duplicate.
Time frame: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation
Concentration of surfactant protein-A
Serum surfactant protein-A concentration measured in duplicate.
Time frame: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation
Concentration of ischemia-modified albumin
Serum ischemia-modified albumin concentration measured in duplicate.
Time frame: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation
Concentration of TNF-alpha
Serum TNF-alpha concentration measured in duplicate.
Time frame: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation
Concentration of total protein
Serum total protein concentration measured in duplicate.
Time frame: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation
Arterial oxygen tension (PaO2)
Time frame: 10 minutes after establishment of assigned oxygen fraction
Intraoperative mean arterial pressure
Time frame: Immediately after intubation and every 15 minutes up to 90 minutes
Intraoperative heart rate
Time frame: Immediately after intubation and every 15 minutes up to 90 minutes
Arterial oxygen tension (PaO2)
Arterial partial pressure of oxygen.
Time frame: 10 minutes after establishment of assigned oxygen fraction
Arterial pH
Arterial pH measured on blood gas analysis.
Time frame: 10 minutes after establishment of assigned oxygen fraction
Arterial carbon dioxide tension (PaCO2)
Arterial partial pressure of carbon dioxide.
Time frame: 10 minutes after establishment of assigned oxygen fraction
Venous oxygen tension (PvO2)
Venous partial pressure of oxygen.
Time frame: 10 minutes after establishment of assigned oxygen fraction
Venous carbon dioxide tension (PvCO2)
Venous partial pressure of carbon dioxide.
Time frame: 10 minutes after establishment of assigned oxygen fraction
Arterial oxygen saturation (SaO2)
Arterial oxygen saturation measured on blood gas analysis.
Time frame: 10 minutes after establishment of assigned oxygen fraction
Venous oxygen saturation (SvO2)
Venous oxygen saturation measured on blood gas analysis.
Time frame: 10 minutes after establishment of assigned oxygen fraction
Arteriovenous oxygen difference
Difference between arterial and venous oxygen saturation.
Time frame: 10 minutes after establishment of assigned oxygen fraction
Lactate concentration
Blood lactate concentration measured on blood gas analysis.
Time frame: 10 minutes after establishment of assigned oxygen fraction
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