Sedative Effect and Safety of Remimazolam Besylate in ARDS Patients

Launched by ZHIMING JIANG · Feb 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new sedative called remimazolam besylate to see how well it works and how safe it is for patients with acute respiratory distress syndrome (ARDS) who need help breathing with a machine, known as mechanical ventilation. The goal is to find out if remimazolam provides better sedation compared to the traditional sedative, midazolam, while minimizing problems like breathing difficulties and confusion. This is important because patients with ARDS often need sedation to tolerate the mechanical ventilator, and finding a better option could improve their care and recovery.

To participate in this study, eligible patients must be between 18 and 65 years old, have ARDS requiring mechanical ventilation for more than three days, and have consent from themselves or their family. Those with certain health conditions, like severe liver disease or a history of substance abuse, cannot join. Participants will receive either remimazolam or midazolam during their treatment and will be closely monitored for any effects. This research is crucial as it aims to provide more evidence on the best sedation practices for ARDS patients in intensive care.

Gender

ALL

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.