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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Sepsis; Lung Injury
• Intervention / Treatment: Drug: Inhalation Anesthesia; Drug: intravenous anesthesia

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Zhao; Phone Number: 0086-13802435520; Email: zhaoy47@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • The sixth affiliated hospital of Sun Yat-Sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: inhalation group	Drug: Inhalation Anesthesia; The inhalation group will be maintained with inhaled sevoflurane and a continuous intravenous infusion of remifentanil.
Experimental: intravenous group	Drug: intravenous anesthesia; The intravenous group will be maintained with continuous intravenous infusions of both ciprofol and remifentanil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ventilator-free days at 7 days after surgery	From the surgery to the 7th day

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Infections; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Lung Diseases; Thoracic Injuries; Pathological Conditions, Signs and Symptoms; Sepsis; Lung Injury; Anesthesia and Analgesia; Anesthesia; Anesthesia, General; Anesthesia, Inhalation; Anesthesia, Intravenous
• Other Study ID Numbers: E2025347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No