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Clinical Study of Esketamine in Patients With Sepsis Undergoing Invasive Mechanical Ventilation

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 29, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
Sepsis is a syndrome of acute organ dysfunction resulting from dysregulated host responses to infection, often leading to severe complications such as acute lung injury and ARDS. ICU patients on mechanical ventilation face multiple noxious stimuli and require effective analgesic and sedative treatments to improve prognosis. The limitations of existing analgesic and sedative drugs are as follows:Opioids (such as remifentanil) have strong analgesic effects but can easily cause adverse reactions such as respiratory depression, hypotension, and gastrointestinal dysfunction.Sedative drugs like midazolam may lead to delirium and gastrointestinal dysfunction.Esketamine exerts its analgesic and sedative effects by non-competitively inhibiting the N-methyl-D-aspartate (NMDA) receptor. It has sympathomimetic activity, which can reduce hemodynamic fluctuations. It also has immunomodulatory effects, which may improve the prognosis of sepsis patients. Currently, esketamine is only used for anesthesia induction in surgery, postoperative analgesia, painless procedures, and as an adjunctive treatment for depression, with limited sample sizes and few reports. There are no large-scale clinical studies on the use of esketamine in sepsis patients undergoing invasive mechanical ventilation, and further verification of its efficacy and safety is needed.
Trial Details
NCT Number NCT07556172
Lead Sponsor Second Affiliated Hospital of Nanchang University
Conditions
(from sponsor)
Sepsis, Mechanical Ventilation
Related terms Sepsis
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov