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NCT Number: NCT07601256

Inhalational Versus Intravenous Anesthesia on Postoperative Lung Injury in Septic Patients Undergoing Surgery

This randomized controlled trial will compare the effects of intraoperative inhalational anesthesia versus intravenous anesthesia on postoperative lung injury in septic patients undergoing surgery. The primary goal is to determine if the choice of anesthetic technique influences the incidence or severity of this complication. Participants will be randomly assigned to one of the two anesthetic regimens during surgery. They will receive daily in-hospital assessments for lung injury and other outcomes and will be followed for clinical outcomes until 90 days after the procedure.

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Key information

Conditions

Sepsis Infections Inflammation Lung Diseases Lung Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Systemic Inflammatory Response Syndrome Thoracic Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years.
  • Diagnosis of sepsis according to Sepsis-3.0 (highly suspected or confirmed infection with acute increase in SOFA score ≥ 2).
  • Scheduled to undergo surgery under general aaesthesia for source control or sepsis-related operative management.

Exclusion criteria

  • Already intubated prior to entering the operating room.
  • Chronic home ventilator dependence (e.g., severe chronic obstructive pulmonary disease) before surgery.
  • Personal or family history of malignant hyperthermia.
  • Known allergy to ciprofol or sevoflurane.
  • Known allergy to egg or soy products.
  • Any contraindication to the planned anaesthetic agents.
  • Pregnant women.

Treatment and study plan

Inhalation Anesthesia

Drug

The inhalation group will be maintained with inhaled sevoflurane and a continuous intravenous infusion of remifentanil.

intravenous anesthesia

Drug

The intravenous group will be maintained with continuous intravenous infusions of both ciprofol and remifentanil.

Primary outcomes

  1. Ventilator-free days at 7 days after surgery

    Time frame: From the surgery to the 7th day

Secondary outcomes

  1. 90-day overall survival

    Time frame: 90-day after surgery

  2. Incidence of Sepsis-Associated Lung Injury at 7 days

    Time frame: 7-day after surgery

  3. All-cause mortality at 7, 14 and 28 days after surgery

    Time frame: 7-day, 14-day and 28-day after surgery

  4. Ventilator-free days at days 14 and 28 after surgery

    Time frame: 14-day, 28-day after surgery

  5. Organ-failure-free at days 7, 14 and 28

    Time frame: 7-day, 14-day, 28-day after surgery

  6. Days alive out of hospital at day 28

    Time frame: 28-day after surgery

  7. Days out of the intensive care unit at day 28

    Time frame: 28-day after surgery

  8. Incidence of postoperative acute kidney injury

    Time frame: 7-day after surgery

  9. Major adverse renal events at day 28

    Time frame: 28-day after surgery

  10. Oxygenation index （PaO₂/FiO₂ ratio）

    Time frame: Baseline before surgery, immediately after surgery, and once daily thereafter until tracheal extubation

  11. Postoperative pulmonary complications

    Time frame: 7-day, 28-day after surgery

  12. Quality of life (EQ-5D-5L) and functional status (ADL)

    Time frame: preoperatively, and on postoperative days 7, 28, 90

  13. Adverse event

    Time frame: 28 days after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Zhao

CONTACT

[email protected]

0086-13802435520

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

Inhalational Versus Intravenous Anesthesia on Lung Injury After Major Surgery in Patients With Sepsis

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 22, 2026
Registry last updated
May 22, 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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