Long-term Sedation With Remimazolam Besylate in Critically Ill Patients

Long-term Sedation With Remimazolam Besylate Versus Propofol in Critically Ill Patients During Invasive Mechanical Ventilation: a Randomized Non-inferior Trial

A randomized non-inferior trial comparing remimazolam besylate with propofol for long-term sedation during invasive mechanical ventilation in critically ill patients

Inclusion Criteria:

• Age ≥ 18 and ≤ 80 years;
• Intubated and mechanically ventilated ≤96 hours before enrollment；
• Expected to require continuous invasive ventilation and sedation ≥24 hours;
• Requirement for light to moderate sedation (a RASS score of -3 to 0)

Exclusion Criteria:

• Body mass index (BMI) <18 or >30 kg/m2;
• Allergy or unsuitabilty to any composition of study drugs or remifentanil;
• Living expectancy less than 48 hours；
• Possible surgey in the operating room in 24 hours；
• Myasthenia gravis;
• Serious hepatic dysfunction (CTP 10-15);
• Chronic kidney disease with glomerular filtration rate (GFR) < 29 ml/min/1.73m2;
• Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors;
• Acute severe neurological disorder and any other condition interfering with RASS assessment;
• Pregnancy or lactation;
• Unstable angina or acute myocardial infarction;
• Left ventricular ejection fraction less than 30%;
• Heart rate less than 50 beats/min;
• Grade 2 , second degree or third degree atrioventricular block in the absence of a pacemaker;
• Abuse of controlled substances or alcohol;
• Other conditions deemed unsuitable to be included;