Long-term Sedation With Remimazolam Besylate in Critically Ill Patients

• Status: Not yet recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Treatments: Propofol

Criteria

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;