Long-term Sedation With Remimazolam Besylate in Critically Ill Patients (LOSREB)

Huazhong University of Science and Technology

Status and phase: Enrolling; Phase 3

Conditions: Light Sedation; Mechanical Ventilation

Treatments: Drug: Propofol; Drug: Remimazolam besylate

Study type: Interventional

Funder types: Other

Identifiers

NCT05555667

WHUICU202209

Details and patient eligibility

About

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

Enrollment: 728 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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728 participants in 2 patient groups

Remimazolam besylate

Experimental group

Description:

Remimazolam besylate at an initial infusion rate of 0.15 mg/kg/h and adjusted (maximum of 0.3 mg/kg/h) to maintain a RASS score between - 3 and 0

Treatment:

Drug: Remimazolam besylate

Propofol

Active Comparator group

Description:

Propofol intravenously at an initial infusion rate of 2.0 mg/kg/h and adjusted (maximum of 4.0 mg/kg/h) to maintain a RASS score between - 3 and 0

Treatment:

Drug: Propofol