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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSixth Affiliated Hospital, Sun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inhalation Anesthesia

    Drug

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

  • intravenous anesthesia

    Drug

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

Treatment groups

480 Participants
are divided into 2 treatment groups
Group A: inhalation groupExperimental treatment 1 intervention
Group B: intravenous groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Ventilator-free days at 7 days after surgery

Time frame
From the surgery to the 7th day

Secondary outcomes

1

90-day overall survival

Time frame
90-day after surgery
2

Incidence of Sepsis-Associated Lung Injury at 7 days

Time frame
7-day after surgery
3

All-cause mortality at 7, 14 and 28 days after surgery

Time frame
7-day, 14-day and 28-day after surgery
4

Ventilator-free days at days 14 and 28 after surgery

Time frame
14-day, 28-day after surgery

Other outcomes

Sponsors and contacts

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