Sepsis, Lung Injury
Conditions
Brief summary
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
DRUGInhalation Anesthesia
The inhalation group will be maintained with inhaled sevoflurane and a continuous intravenous infusion of remifentanil.
The intravenous group will be maintained with continuous intravenous infusions of both ciprofol and remifentanil.
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Personnel responsible for participant recruitment, data collection, and outcome assessment, as well as the enrolled participants themselves, will be blinded to the group assignments. However, blinding of the intraoperative anesthesiologists is not feasible due to the visibly distinct nature of the two anesthesia regimes.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years. 2. Diagnosis of sepsis according to Sepsis-3.0 (highly suspected or confirmed infection with acute increase in SOFA score ≥ 2). 3. Scheduled to undergo surgery under general aaesthesia for source control or sepsis-related operative management.
Exclusion criteria
1. Already intubated prior to entering the operating room. 2. Chronic home ventilator dependence (e.g., severe chronic obstructive pulmonary disease) before surgery. 3. Personal or family history of malignant hyperthermia. 4. Known allergy to ciprofol or sevoflurane. 5. Known allergy to egg or soy products. 6. Any contraindication to the planned anaesthetic agents. 7. Pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ventilator-free days at 7 days after surgery | From the surgery to the 7th day |
Secondary
| Measure | Time frame |
|---|---|
| 90-day overall survival | 90-day after surgery |
| Incidence of Sepsis-Associated Lung Injury at 7 days | 7-day after surgery |
| All-cause mortality at 7, 14 and 28 days after surgery | 7-day, 14-day and 28-day after surgery |
| Ventilator-free days at days 14 and 28 after surgery | 14-day, 28-day after surgery |
| Organ-failure-free at days 7, 14 and 28 | 7-day, 14-day, 28-day after surgery |
| Days alive out of hospital at day 28 | 28-day after surgery |
| Days out of the intensive care unit at day 28 | 28-day after surgery |
| Incidence of postoperative acute kidney injury | 7-day after surgery |
| Major adverse renal events at day 28 | 28-day after surgery |
| Oxygenation index （PaO₂/FiO₂ ratio） | Baseline before surgery, immediately after surgery, and once daily thereafter until tracheal extubation |
| Postoperative pulmonary complications | 7-day, 28-day after surgery |
| Quality of life (EQ-5D-5L) and functional status (ADL) | preoperatively, and on postoperative days 7, 28, 90 |
| Adverse event | 28 days after surgery |
Countries
China
Contacts
CONTACTYang Zhao
Outcome results
None listed