Sedation Efficacy and Safety of Remazolam Besylate in Ventilated Surgical Critically Ill Patients
Launched by BEIJING SHIJITAN HOSPITAL, CAPITAL MEDICAL UNIVERSITY · Aug 26, 2024
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the safety and effectiveness of a drug called remazolam besylate for sedating critically ill patients who need help breathing with a ventilator after surgery. Researchers want to find out if remazolam besylate works as well as another sedation drug called dexmedetomidine. The trial is currently looking for volunteers who are between 18 and 64 years old, have undergone non-cardiac surgery requiring general anesthesia, and will need to be on a ventilator for more than 24 hours in the intensive care unit (ICU).
Participants in this study can expect to receive either remazolam besylate or dexmedetomidine during their time in the ICU. The study aims to help improve sedation practices for patients who are critically ill and to ensure that the sedation provided is both safe and effective. It’s important to note that some individuals may not be eligible to participate, including those with certain medical conditions or those who have taken specific medications recently. If you or a loved one are considering this trial, it's a good idea to discuss it with your healthcare team for more personalized information.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 18-64 years old
- • must accept no-cardiac elective surgery
- • must under general anaesthesia
- • can be combined regional tissue anesthesia
- • must admitted to ICU with tracheal intubation after general anaesthesia - expected mechanical ventilation time must more than 24 hours
- • light or moderate sedation must needed
- Exclusion Criteria:
- • intracranial surgery or severe neurological or spinal cord disease
- • schizophrenia, epilepsy, and Parkinson's disease
- • coma, severe dementia, or language barrier before surgery
- • cardiac dysfunction or arrhythmia
- • severe liver dysfunction(Child-Pugh C class)
- • severe kidney dysfunction
- • use of dexmedetomidine or remifentanil besylate 24 hours before or during surgery
- • pregnancy or lactation
- • any investigational drug useage 30 days before surgery
- • refuse to participant.
About Beijing Shijitan Hospital, Capital Medical University
Beijing Shijitan Hospital, affiliated with Capital Medical University, is a leading medical institution in China renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on patient-centered care and a multidisciplinary approach, the hospital is dedicated to conducting high-quality clinical trials that contribute to the understanding and treatment of various medical conditions. Leveraging its extensive network of healthcare professionals and state-of-the-art facilities, Beijing Shijitan Hospital plays a pivotal role in fostering medical advancements and improving therapeutic outcomes through rigorous scientific investigation and collaboration within the global research community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Beijing, Beijing, China
Patients applied
Trial Officials
Jianxin Zhou, doctor
Study Chair
Beijing Shijitan Hospital, Capital Medical University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported