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

May 15, 2026 updated by: Yang Zhao, Sixth Affiliated Hospital, Sun Yat-sen University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
480

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Ventilator-free days at 7 days after surgery
Time Frame: From the surgery to the 7th day
From the surgery to the 7th day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
90-day overall survival
Time Frame: 90-day after surgery
90-day after surgery
Incidence of Sepsis-Associated Lung Injury at 7 days
Time Frame: 7-day after surgery
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
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
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
7-day, 14-day, 28-day after surgery
Days alive out of hospital at day 28
Time Frame: 28-day after surgery
28-day after surgery
Days out of the intensive care unit at day 28
Time Frame: 28-day after surgery
28-day after surgery
Incidence of postoperative acute kidney injury
Time Frame: 7-day after surgery
7-day after surgery
Major adverse renal events at day 28
Time Frame: 28-day after surgery
28-day after surgery
Oxygenation index （PaO₂/FiO₂ ratio）
Time Frame: Baseline before surgery, immediately after surgery, and once daily thereafter until tracheal extubation
Baseline before surgery, immediately after surgery, and once daily thereafter until tracheal extubation
Postoperative pulmonary complications
Time Frame: 7-day, 28-day after surgery
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
preoperatively, and on postoperative days 7, 28, 90
Adverse event
Time Frame: 28 days after surgery
28 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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