Combining esketamine and dexmedetomidine for sedation in ICU patients on mechanical ventilation

Safety and Efficacy of Esketamine Combined With Dexmedetomidine for Sedation of Mechanically Ventilated Patients in the ICU: a Prospective, Randomized, Single-center Study

This study is testing if using esketamine together with dexmedetomidine can help ICU patients on ventilators wake up faster and have a better overall experience.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05466708 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of using esketamine in combination with dexmedetomidine for sedation and analgesia in mechanically ventilated patients in the ICU. The study is a prospective, randomized controlled trial that aims to compare the effects of this combination on various outcomes, including time to awaken, extubation, and overall ICU duration. The approach leverages the rapid onset and analgesic properties of esketamine alongside the sedative benefits of dexmedetomidine, aiming to improve patient outcomes while maintaining hemodynamic stability.

Who should consider this trial

Good fit: Ideal candidates are mechanically ventilated patients aged 18 to 70 years with an expected mechanical ventilation duration of over 24 hours.

Not a fit: Patients with severe hemodynamic or respiratory instability, significant allergies to the study drugs, or those who are terminally ill may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance sedation and analgesia for ICU patients, potentially reducing the duration of mechanical ventilation and incidence of delirium.

How similar studies have performed: Previous studies have shown promising results with similar combinations of sedatives, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Mechanically ventilated with oral endotracheal intubation in the ICU;
* Patients aged \>18 years and \<70 years;
* Patients with expected mechanical ventilation time \>24 hours.

Exclusion Criteria:

* Known or suspected allergy to esketamine, dexmedetomidine, remifentanil, or propofol;
* Pregnancy or lactation periods;
* Obesity defined as Body Mass Index \>35kg/m2;
* Extreme hemodynamic or respiratory instability due to severe burn or trauma (defined as Injury Severity Score ≥25);
* Heavy drinking defined by WHO as drinking at least 60g of pure alcohol every day for men and at least 40g for women;
* Terminally ill patients near death, such as patients with extensively metastatic tumor or refractory shock;
* Long-term exposure to sedatives, opioid analgesics or antianxiety drugs;
* Severe central nervous system disease such as cerebrovascular accidents, status epilepsy, or coma;
* Acute or chronic severe liver disease (Child-Pugh class C or history of liver transplant);
* Acute or chronic renal insufficiency needing dialysis;
* Patients or authorized surrogates refuse to provide informed consents;
* Mechanically ventilated for more than 24 hours prior to enrollment (not including the time on ventilators in the operation room).

Where this trial is running

Nanjing, Jiangsu

• The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Zuo Xiangrong

Conditions Dexmedetomidine; Ketamine; Analgesia; Intensive Care Units; Mechanical Ventilation; Esketamine; Sedation