Long-term sedation using 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

This study tests if a new sedation drug called remimazolam works as well or better than the standard drug propofol for critically ill patients on mechanical ventilation who need long-term sedation.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 728 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Wuhan Union Hospital, China (Academic / other)
• Locations: 1 site (Wuhan)
• Trial ID: NCT05555667 on ClinicalTrials.gov

What this trial studies

This trial compares the effectiveness of remimazolam besylate to propofol for providing long-term sedation in critically ill patients who are on mechanical ventilation. It is a randomized non-inferior trial designed to assess the safety and efficacy of remimazolam besylate for light to moderate sedation during invasive mechanical ventilation. Eligible participants are those who are intubated and expected to require sedation for at least 24 hours. The study aims to determine if remimazolam can provide similar or better sedation outcomes compared to the standard treatment with propofol.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 who are intubated and mechanically ventilated for less than 96 hours and require sedation for at least 24 hours.

Not a fit: Patients with severe comorbidities, unstable conditions, or contraindications to the study drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve sedation management in critically ill patients, potentially leading to better patient outcomes and comfort.

How similar studies have performed: Other studies have shown promising results with remimazolam in sedation, but this specific comparison with propofol in critically ill patients is novel.

Eligibility 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;

Where this trial is running

Wuhan

• Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China (Recruiting)

Study contacts

• Study coordinator: You Shang, MD

Conditions Light Sedation; Mechanical Ventilation