NCT07525661

Perioperative Hyperoxia vs Normoxia Biomarker Trial

Effects of Perioperative Hyperoxia Versus Normoxia on Pulmonary, Endothelial, and Inflammatory Biomarkers in Elective Laparoscopic Lower Abdominal Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Istanbul University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hyperoxia
• Perioperative Care
• Oxidative Stress
• Endothelial Glycocalyx Injury

Interventions

Type	Name	Description
OTHER	Perioperative Oxygen Strategy - Normoxia	Normoxia arm: FiO2 0.35 Intervention started immediately after intubation and maintained intraoperatively
OTHER	Perioperative Oxygen Strategy-Hyperoxia	Hyperoxia arm: FiO2 0.80 Intervention started immediately after intubation and maintained intraoperatively

Timeline

• Start date: 2017-07-01
• Primary completion: 2019-01-01
• Completion: 2019-02-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Turkey (Türkiye)