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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normoxia | Experimental | Intraoperative inspired oxygen fraction (FiO2) of 0.35 under standardized general anesthesia and volume-controlled ventilation. |
|
| Hyperoxia | Experimental | Intraoperative inspired oxygen fraction (FiO2) of 0.80 under standardized general anesthesia and volume-controlled ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perioperative Oxygen Strategy - Normoxia | Other | Normoxia arm: FiO2 0.35 Intervention started immediately after intubation and maintained intraoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of syndecan-1 | Serum syndecan-1 concentration measured in duplicate. | 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. | 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. | 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. | 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. | 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. | 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University, Istanbul Faculty of Medicine | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40673571 | Background | Lopez MG, Pandey AK, Hennessy C, Hughes CG, Absi TS, Shah AS, Shotwell MS, Harrison DG, Billings FT 4th; ROCS Trial Investigators. Effects of Oxygen on Perioperative Vascular Function: A Randomized Clinical Trial. J Am Heart Assoc. 2025 Aug 5;14(15):e041778. doi: 10.1161/JAHA.125.041778. Epub 2025 Jul 17. | |
| 41702329 | Background |
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| ID | Term |
|---|---|
| D018496 | Hyperoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Perioperative Oxygen Strategy-Hyperoxia | Other | Hyperoxia arm: FiO2 0.80 Intervention started immediately after intubation and maintained intraoperatively |
|
| Intraoperative heart rate | Immediately after intubation and every 15 minutes up to 90 minutes |
| Arterial oxygen tension (PaO2) | Arterial partial pressure of oxygen. | 10 minutes after establishment of assigned oxygen fraction |
| Arterial pH | Arterial pH measured on blood gas analysis. | 10 minutes after establishment of assigned oxygen fraction |
| Arterial carbon dioxide tension (PaCO2) | Arterial partial pressure of carbon dioxide. | 10 minutes after establishment of assigned oxygen fraction |
| Venous oxygen tension (PvO2) | Venous partial pressure of oxygen. | 10 minutes after establishment of assigned oxygen fraction |
| Venous carbon dioxide tension (PvCO2) | Venous partial pressure of carbon dioxide. | 10 minutes after establishment of assigned oxygen fraction |
| Arterial oxygen saturation (SaO2) | Arterial oxygen saturation measured on blood gas analysis. | 10 minutes after establishment of assigned oxygen fraction |
| Venous oxygen saturation (SvO2) | Venous oxygen saturation measured on blood gas analysis. | 10 minutes after establishment of assigned oxygen fraction |
| Arteriovenous oxygen difference | Difference between arterial and venous oxygen saturation. | 10 minutes after establishment of assigned oxygen fraction |
| Lactate concentration | Blood lactate concentration measured on blood gas analysis. | 10 minutes after establishment of assigned oxygen fraction |
| Farag E, Esa Y, Chehade NEH, Sleiman VB, Seif J. Endothelial glycocalyx in perioperative medicine current understanding and future direction. J Clin Anesth. 2026 Mar;110:112154. doi: 10.1016/j.jclinane.2026.112154. Epub 2026 Feb 16. |
| 38545565 | Background | Larvin J, Edwards M, Martin DS, Feelisch M, Grocott MPW, Cumpstey AF. Perioperative oxygenation-what's the stress? BJA Open. 2024 Mar 20;10:100277. doi: 10.1016/j.bjao.2024.100277. eCollection 2024 Jun. |
| 19826023 | Background | Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Hogdall C, Lundvall L, Svendsen PE, Mollerup H, Lunn TH, Simonsen I, Martinsen KR, Pulawska T, Bundgaard L, Bugge L, Hansen EG, Riber C, Gocht-Jensen P, Walker LR, Bendtsen A, Johansson G, Skovgaard N, Helto K, Poukinski A, Korshin A, Walli A, Bulut M, Carlsson PS, Rodt SA, Lundbech LB, Rask H, Buch N, Perdawid SK, Reza J, Jensen KV, Carlsen CG, Jensen FS, Rasmussen LS; PROXI Trial Group. Effect of high perioperative oxygen fraction on surgical site infection and pulmonary complications after abdominal surgery: the PROXI randomized clinical trial. JAMA. 2009 Oct 14;302(14):1543-50. doi: 10.1001/jama.2009.1452. |
| 40483181 | Background | Elfeky A, Chen YF, Grove A, Couper K, Court R, Tomassini S, Wilson A, Hooper A, Buckle A, Vadeyar S, Thompson M, Uthman O, Yeung J. Perioperative oxygen therapy: an overview of systematic reviews and meta-analyses. Br J Anaesth. 2025 Nov;135(5):1456-1476. doi: 10.1016/j.bja.2025.04.020. Epub 2025 Jun 6. |