Using Esketamine for Pain Relief in ICU Patients with Septic Shock

Adjunctive Esketamine for Analgesia in Mechanically Ventilated ICU Septic Shock Patients

This study is testing if low doses of esketamine can help relieve pain and sedation in ICU patients with septic shock who are on ventilators, compared to standard pain medications.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 124 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (other)
• Locations: 1 site (Guangzhou)
• Trial ID: NCT05839366 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of esketamine as an adjunctive analgesic and sedative for patients with septic shock who are mechanically ventilated. The study aims to evaluate the feasibility, effectiveness, and safety of low-dose esketamine compared to standard analgesia and sedation protocols involving remifentanil and propofol. By focusing on patients who require prolonged sedation and analgesia, the trial seeks to determine if esketamine can provide effective pain relief without exacerbating hemodynamic instability or respiratory depression. This single-center randomized controlled trial will provide valuable insights into the potential benefits of esketamine in this critical patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with septic shock requiring mechanical ventilation and sedation for at least 48 hours.

Not a fit: Patients who are pregnant, have severe neurological conditions, or a history of uncontrolled hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve pain management and sedation in critically ill patients, potentially leading to better outcomes in septic shock.

How similar studies have performed: While esketamine has shown promise in other settings, this specific application in mechanically ventilated septic shock patients is novel and has not been extensively tested.

Eligibility 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:

* Currently pregnant or breastfeeding;
* Confirmed acute severe intracranial or spinal neurologic diseases caused by vascular, intracranial expansion, or injury;
* History of uncontrolled or malignant hypertension (sustained (\>3 hours) heart rate \>150 beats/min or systolic blood pressure \>180 mmHg); recent history of ketamine use；
* Hearing or vision loss, or any other conditions likely to severely interfere with the collection of research data;
* Long-term use of benzodiazepines or opioids;
* Known allergy to any investigational drug;
* Subject receiving sedative therapy not for tolerance to mechanical ventilation (e.g., seizures);
* Unlikely to require ongoing sedation during mechanical ventilation (e.g., Guillain-Barré syndrome);
* Patients deemed unlikely by the attending physician to be weaned from mechanical ventilation, such as those with diseases/injuries primarily affecting respiratory neuromuscular function and conditions requiring prolonged ventilatory support, which are clearly irreversible (e.g., high spinal cord injury);
* Open eye injury or other ophthalmic diseases;
* Concurrent participation in any other interventional study (any study assigning subjects to different treatment groups and/or conducting unconventional diagnostic or monitoring procedures).

Where this trial is running

Guangzhou

• Southern medical university Nanfang hospital — Guangzhou, China (RECRUITING)

Study contacts

• Study coordinator: Hongbin Hu, doctor

Conditions: Septic Shock, Mechanical Ventilation Complication, Esketamine, Vasoactive drugs, sedation, analgesia