Remimazolam Besylate in Sedation of Postcardioperative Patients

Launched by FIRST AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY · Nov 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called remimazolam besylate to see if it works well for sedating patients who have just had heart surgery and are in the intensive care unit (ICU). After heart surgery, patients often need help with breathing, which means they are connected to a machine called a ventilator. Sedation is important during this time to keep patients comfortable and calm. The goal of this study is to find out if remimazolam is a better option for sedation compared to the commonly used drug propofol, especially in terms of how well it works and its safety.

To be eligible for the trial, participants must be at least 18 years old, have undergone heart surgery, and still need mechanical ventilation but are expected to be taken off the ventilator within 48 hours. They also need to give their consent to participate. During the trial, participants will be randomly assigned to receive either remimazolam or propofol for sedation. The researchers will closely monitor how each medication affects the patients and how quickly they can wake up and recover. This study aims to find a safer and more effective way to manage sedation for patients in the ICU after heart surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. age ≥ 18 years ;
• • 2. admitted to the intensive care unit after cardiac surgery with techanical ventilation；
• • 3. expected to extubation within 48hours ；
• • 4. participant has given informed consent
• Exclusion Criteria:
• • 1. pregnant or lactating women
• • 2. known or suspected hypersensitivity to the study drug
• • 3. history of impaired consciousness or psychiatric illness
• • 4. severe bradycardia with a heart rate of \< 50 beats per minute
• • 5. systolic blood pressure \< 90 mmHg with fluid resuscitation and vasopressor maintenance
• • 6. atrioventricular block（II or III degree）, Left ventricular ejection fraction(LVEF) \<30%
• • 7. participated in other clinical studies within 3 months