SepsisNCT07601256
Inhalational Versus Intravenous Anesthesia on Postoperative Lung Injury in Septic Patients Undergoing Surgery
A study testing Inhalation Anesthesia and intravenous anesthesia in people with Sepsis and Lung Injury, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Lung Injury
- What is being tested?
- Inhalation Anesthesia and intravenous anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2026to 30 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
About this study
Official title: 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.
- Conditions
- Sepsis, Lung Injury
- Being tested
- Inhalation Anesthesia, intravenous anesthesia
- Medical subject headings
- Sepsis, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhalation AnesthesiaDrug
The inhalation group will be maintained with inhaled sevoflurane and a continuous intravenous infusion of remifentanil.
intravenous anesthesiaDrug
The intravenous group will be maintained with continuous intravenous infusions of both ciprofol and remifentanil.
| Study group | Role | What they receive |
|---|---|---|
| inhalation group | Experimental | Not described Receives: Drug: Inhalation Anesthesia |
| intravenous group | Experimental | Not described Receives: Drug: intravenous anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free days at 7 days after surgery
Measured: From the surgery to the 7th day
Secondary outcomes (13)
90-day overall survival
Measured: 90-day after surgery
Incidence of Sepsis-Associated Lung Injury at 7 days
Measured: 7-day after surgery
All-cause mortality at 7, 14 and 28 days after surgery
Measured: 7-day, 14-day and 28-day after surgery
Ventilator-free days at days 14 and 28 after surgery
Measured: 14-day, 28-day after surgery
Organ-failure-free at days 7, 14 and 28
Measured: 7-day, 14-day, 28-day after surgery
Days alive out of hospital at day 28
Measured: 28-day after surgery
Days out of the intensive care unit at day 28
Measured: 28-day after surgery
Incidence of postoperative acute kidney injury
Measured: 7-day after surgery
Major adverse renal events at day 28
Measured: 28-day after surgery
Oxygenation index （PaO₂/FiO₂ ratio）
Measured: Baseline before surgery, immediately after surgery, and once daily thereafter until tracheal extubation
Postoperative pulmonary complications
Measured: 7-day, 28-day after surgery
Quality of life (EQ-5D-5L) and functional status (ADL)
Measured: preoperatively, and on postoperative days 7, 28, 90
Adverse event
Measured: 28 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start15 Aug 2026 (estimated)
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Zhao, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601256
- Sponsor's protocol ID
- E2025347
- Status last verified
- Dec 2025
- First submitted
- 30 Jan 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhalational Versus Intravenous Anesthesia on Lung Injury After Major Surgery in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT07601256
- Acronym / sponsor ID
- E2025347
- Conditions
- Sepsis, Lung Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inhalation group | Experimental | Drug: Inhalation Anesthesia |
| intravenous group | Experimental | Drug: intravenous anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhalation AnesthesiaThe inhalation group will be maintained with inhaled sevoflurane and a continuous intravenous infusion of remifentanil. | Drug | inhalation group |
| intravenous anesthesiaThe intravenous group will be maintained with continuous intravenous infusions of both ciprofol and remifentanil. | Drug | intravenous group |
Primary outcome
Ventilator-free days at 7 days after surgery
Time frame: From the surgery to the 7th day
13 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhalation Anesthesia and intravenous anesthesia in people with Sepsis and Lung Injury, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Zhao (0086-13802435520, zhaoy47@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free days at 7 days after surgery (time frame: From the surgery to the 7th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.