Adjunctive Esketamine for Analgesia in Mechanically Ventilated Septic Shock Patients

• Status: Recruiting
• Trial end date: 2024-10-31
• Target enrollment: 0
• Participant gender: All

Summary

Sedation and analgesia in patients with sepsis and hemodynamic instability may be challenging in the ICU. Opioids and propofol can further exacerbate tissue infusion in septic shock by reducing cardiac contractility, increasing vasodilation, and reducing respiratory drive. Ketamine is an NMDA receptor antagonist, which has no effect on respiratory drive and has diastolic airway smooth muscle and anti-inflammatory properties. Esketamine is a dextrorotatory cleavage twice as potent and reduces the incidence of dose-dependent side effects of ketamine. Although it has been successfully used in burn patients undergoing multiple operations and anesthesia-related maintenance analgesia, it has not been reported in ICU septic shock patients undergoing mechanical ventilation. The purpose of this study was to explore the use of esketamine in mechanically ventilated ICU septic shock patients in a single-center randomized controlled trial.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Treatments: Esketamine; Propofol; Remifentanil

Criteria

Inclusion Criteria:

• Age ≥ 18;

• A patient diagnosed with septic shock;

• It needs to be treated with analgesics, sedatives, and vasopressors for a period of not less than 48 hours;

• Mechanical ventilation by the ventilator is needed;

• Obtain the informed consent of the human subjects or their legal representatives;

Exclusion Criteria:

• Pregnant patient

• The patient had acute coronary syndrome, NYHA grade IV, or refractory heart failure;

• Any other condition that may seriously interfere with the collection of research data, such as loss of hearing or vision;

• any allergic reaction to any of the research drugs;

• The clinician determines that a patient who is unlikely to be separated from mechanical ventilation, such as a disease/injury that primarily affects the neuromuscular function of the respirator and an apparently irreversible disease requiring long-term ventilation support (such as high spinal cord injury);

• The researcher judged that it was not suitable to participate in the study;