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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
480
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.
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Ventilator-free days at 7 days after surgery
Time frame: From the surgery to the 7th day
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
Adverse event
Time frame: 28 days after surgery
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