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Completed

NCT Number: NCT07525661

Perioperative Hyperoxia vs Normoxia Biomarker Trial

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University, Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Perioperative Oxygen Strategy - Normoxia

Other

Normoxia arm: FiO2 0.35 Intervention started immediately after intubation and maintained intraoperatively

Perioperative Oxygen Strategy-Hyperoxia

Other

Hyperoxia arm: FiO2 0.80 Intervention started immediately after intubation and maintained intraoperatively

Primary outcomes

  1. Concentration of syndecan-1

    Time frame: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

    Serum syndecan-1 concentration measured in duplicate.

  2. Concentration of sialic acid

    Time frame: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

    Serum sialic acid concentration measured in duplicate.

  3. Concentration of surfactant protein-A

    Time frame: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

    Serum surfactant protein-A concentration measured in duplicate.

  4. Concentration of ischemia-modified albumin

    Time frame: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

    Serum ischemia-modified albumin concentration measured in duplicate.

  5. Concentration of TNF-alpha

    Time frame: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

    Serum TNF-alpha concentration measured in duplicate.

  6. Concentration of total protein

    Time frame: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

    Serum total protein concentration measured in duplicate.

Secondary outcomes

  1. Arterial oxygen tension (PaO2)

    Time frame: 10 minutes after establishment of assigned oxygen fraction

  2. Intraoperative mean arterial pressure

    Time frame: Immediately after intubation and every 15 minutes up to 90 minutes

  3. Intraoperative heart rate

    Time frame: Immediately after intubation and every 15 minutes up to 90 minutes

  4. Arterial oxygen tension (PaO2)

    Time frame: 10 minutes after establishment of assigned oxygen fraction

    Arterial partial pressure of oxygen.

  5. Arterial pH

    Time frame: 10 minutes after establishment of assigned oxygen fraction

    Arterial pH measured on blood gas analysis.

  6. Arterial carbon dioxide tension (PaCO2)

    Time frame: 10 minutes after establishment of assigned oxygen fraction

    Arterial partial pressure of carbon dioxide.

  7. Venous oxygen tension (PvO2)

    Time frame: 10 minutes after establishment of assigned oxygen fraction

    Venous partial pressure of oxygen.

  8. Venous carbon dioxide tension (PvCO2)

    Time frame: 10 minutes after establishment of assigned oxygen fraction

    Venous partial pressure of carbon dioxide.

  9. Arterial oxygen saturation (SaO2)

    Time frame: 10 minutes after establishment of assigned oxygen fraction

    Arterial oxygen saturation measured on blood gas analysis.

  10. Venous oxygen saturation (SvO2)

    Time frame: 10 minutes after establishment of assigned oxygen fraction

    Venous oxygen saturation measured on blood gas analysis.

  11. Arteriovenous oxygen difference

    Time frame: 10 minutes after establishment of assigned oxygen fraction

    Difference between arterial and venous oxygen saturation.

  12. Lactate concentration

    Time frame: 10 minutes after establishment of assigned oxygen fraction

    Blood lactate concentration measured on blood gas analysis.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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