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

NCT07601256 | Not Yet Recruiting DMC

• 1 other identifier: E2025347
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Lung Injury

Outcome Measures

Primary Outcomes (1)

• Ventilator-free days at 7 days after surgery

  From the surgery to the 7th day

Secondary Outcomes (13)

• 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

Study Arms (2)

inhalation group

EXPERIMENTAL

Drug: Inhalation Anesthesia

intravenous group

EXPERIMENTAL

Drug: intravenous anesthesia

Interventions

Inhalation Anesthesia DRUG

The inhalation group will be maintained with inhaled sevoflurane and a continuous intravenous infusion of remifentanil.

inhalation group

intravenous anesthesia DRUG

The intravenous group will be maintained with continuous intravenous infusions of both ciprofol and remifentanil.

intravenous group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

MeSH Terms

Conditions

Sepsis; Lung Injury

Interventions

Anesthesia, Inhalation; Anesthesia, Intravenous

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anesthesia, General; Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Yang Zhao

CONTACT

0086-13802435520; zhaoy47@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: May 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)