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Not yet recruiting NCT07601256

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

No phase Interventional Sepsis Lung Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inhalation Anesthesia, intravenous anesthesia.
Who it may be relevant to
Registry conditions: Sepsis, Lung Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Inhalation Anesthesia
    The inhalation group will be maintained with inhaled sevoflurane and a continuous intravenous infusion of remifentanil.
  • Drug intravenous anesthesia
    The intravenous group will be maintained with continuous intravenous infusions of both ciprofol and remifentanil.

Primary outcome measures

  • Ventilator-free days at 7 days after surgery [Time frame: From the surgery to the 7th day]
Secondary outcome measures (12)
  • 90-day overall survival [Time frame: 90-day after surgery]
  • Incidence of Sepsis-Associated Lung Injury at 7 days [Time frame: 7-day after surgery]
  • All-cause mortality at 7, 14 and 28 days after surgery [Time frame: 7-day, 14-day and 28-day after surgery]
  • Ventilator-free days at days 14 and 28 after surgery [Time frame: 14-day, 28-day after surgery]
  • Organ-failure-free at days 7, 14 and 28 [Time frame: 7-day, 14-day, 28-day after surgery]
  • Days alive out of hospital at day 28 [Time frame: 28-day after surgery]
  • Days out of the intensive care unit at day 28 [Time frame: 28-day after surgery]
  • Incidence of postoperative acute kidney injury [Time frame: 7-day after surgery]
  • Major adverse renal events at day 28 [Time frame: 28-day after surgery]
  • Oxygenation index （PaO₂/FiO₂ ratio） [Time frame: Baseline before surgery, immediately after surgery, and once daily thereafter until tracheal extubation]
  • Postoperative pulmonary complications [Time frame: 7-day, 28-day after surgery]
  • Quality of life (EQ-5D-5L) and functional status (ADL) [Time frame: preoperatively, and on postoperative days 7, 28, 90]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

China · 1 center
  • The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT07601256 · E2025347

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗