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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| inhalation group | Experimental |
| |
| intravenous group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhalation Anesthesia | Drug | The inhalation group will be maintained with inhaled sevoflurane and a continuous intravenous infusion of remifentanil. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-free days at 7 days after surgery | From the surgery to the 7th day |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Zhao | Contact | 0086-13802435520 | zhaoy47@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510655 | China |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D055370 | Lung Injury |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000769 | Anesthesia, Inhalation |
| D000771 | Anesthesia, Intravenous |
| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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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.
| intravenous anesthesia | Drug | The intravenous group will be maintained with continuous intravenous infusions of both ciprofol and remifentanil. |
|
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013898 | Thoracic Injuries |
| D014947 | Wounds and Injuries |