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

Condition(s) studied

Investigational drug(s) / intervention(s)

Esketamine: patients received intravenous target-controlled infusion of midazolam (5mg/1ml per vial, Jiangsu Hengrui Medicine) for sedation, with a loading dose of 0.05mg/kg administered intravenously over 2 minutes, and a maintenance dose of 0.03-0.2mg/kg·h. The sedation target was a RASS score of -2 to 0. The RASS score was assessed every 4 hours, and the midazolam dose was adjusted based on the score.Esketamine (50mg/2ml per vial, Jiangsu Hengrui Medicine) was administered intravenously at a dose of 0.15-0.5mg/kg·h for analgesia. The analgesic target was a COPT (Composite Pain Scale) score of less than 3 points, and the dose of esketamine was adjusted according to the COPT score.

Remifentanil: patients received intravenous target-controlled infusion of midazolam (5mg/1ml per vial, Jiangsu Hengrui Medicine) for sedation, with a loading dose of 0.05mg/kg administered intravenously over 2 minutes, and a maintenance dose of 0.03-0.2mg/kg·h. The sedation target was a RASS score of -2 to 0. The RASS score was assessed every 4 hours, and the midazolam dose was adjusted based on the score.Remifentanil (1mg per vial, Yichang Humanwell Pharmaceutical) was administered intravenously at a dose of 0.05-2ug/kg·min for analgesia. The analgesic target was also a COPT score of less than 3 points, and the dose of remifentanil was adjusted based on the COPT score.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Duration of mechanical ventilation — From intubation to the first successful extubation sustained for ≥48 hours, death, or Day 28, whichever occurs first
  Duration of mechanical ventilation is defined as the cumulative length of time (in hours or days) from the initiation of invasive mechanical ventilation to the first successful liberation from the ventilator for ≥48 consecutive hours, or to death, whichever occurs first

Trial sites (1)

More Second Affiliated Hospital of Nanchang University trials in China

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