Evaluating the sedative effects of Remimazolam Besylate in patients with ARDS

Clinical Study on Sedative Effect and Safety of Remimazolam Besylate in ARDS Patients With Mechanical Ventilation

This study is testing a new sedative called Remimazolam Besylate to see if it works better than traditional options for adults with Acute Respiratory Distress Syndrome who need help breathing with a ventilator.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Qianfoshan Hospital (Academic / other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT05758597 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of Remimazolam Besylate as a sedative for patients with Acute Respiratory Distress Syndrome (ARDS) who require mechanical ventilation. The study aims to compare Remimazolam Besylate with traditional sedatives like midazolam, focusing on sedation quality, recovery time, and respiratory stability. Given the limitations of current sedatives, this trial seeks to provide evidence for a potentially superior alternative that minimizes respiratory depression and enhances recovery. The trial will enroll adult patients aged 18 to 65 who meet specific ARDS criteria and require prolonged mechanical ventilation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with ARDS requiring invasive mechanical ventilation for more than three days.

Not a fit: Patients with severe liver disease, significant neurological conditions, or those with a history of substance abuse may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective sedation option for ARDS patients on mechanical ventilation.

How similar studies have performed: While there are few studies on Remimazolam Besylate in ICU settings, the approach of using ultra-short-acting sedatives has shown promise in other contexts.

Eligibility criteria

Inclusion criteria:

1. Age ≥18 years old and ≤65 years old
2. ARDS patients admitted to ICU requiring invasive mechanical ventilation (meeting the 2012 Berlin diagnostic criteria for ARDS)
3. Expected mechanical ventilation time \> 3 days
4. Obtain informed consent from patients or family members

Exclusion Criteria:

1. Pregnancy or lactation
2. Patients with myasthenia gravis, acute myocardial ischemia or severe arrhythmia
3. Severe, pre-existing substantive liver disease with clinically significant portal hypertension, Child-Pugh C cirrhosis, or acute liver failure
4. Severe craniocerebral injury, brain tumor, increased intracranial pressure, cerebrovascular accident, coma, epilepsy, etc.
5. Patients with a history of alcohol or drug abuse or chronic pain requiring long- term use of analgesic and sedative drugs
6. Any conditions that interfere with the correct assessment of cognitive function, such as language and sensory disorders or mental disorders (language difficulties or organic mental dysfunction
7. Participate in other exploratory clinical trials within 3 months prior to screening
8. Known or suspected allergies to remazolam besylate, midazolam, propofol, and opioids.

Where this trial is running

Jinan, Shandong

• Department of Intensive Care Medicine — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Quanzhen Wang, doctor

Conditions Respiratory Distress Syndrome