Safety and Efficacy of Esketamine Combined With Dexmedetomidine for Sedation of Mechanically Ventilated Patients

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Jul 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of two medications, esketamine and dexmedetomidine, to help sedate and relieve pain in patients who are on mechanical ventilation in the Intensive Care Unit (ICU). The goal is to see how these medications affect how quickly patients can wake up, be taken off the ventilator, and recover in the ICU, while also checking for any confusion or delirium that might occur.

To be eligible for this trial, patients need to be adults aged 18 to 70 who are currently on a ventilator and expect to need it for more than 24 hours. However, certain individuals cannot participate, such as those with severe allergies to the medications being studied, pregnant or breastfeeding women, and patients with serious health issues like severe liver disease or those who are terminally ill. Participants will be closely monitored during the study, and the information gathered may help improve sedation and pain management for future ICU patients.

Gender

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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).