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

2021120884Esketamine

A prospective, randomized controlled study was conducted to compare the effects of esketamine combined with dexmedetomidine in the sedation and analgesia treatment of mechanically ventilated patients in the ICU on the time to awaken, time to extubation, time to mechanical ventilation, time in the ICU, and on delirium.

2022-08-11

2024-12-01

2024-12-01

Recruiting

Early phase I

100

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).

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-05-07