Status:
RECRUITING
Sedation Efficacy and Safety of Remazolam Besylate in Ventilated Surgical Critically Ill Patients
Lead Sponsor:
Beijing Shijitan Hospital, Capital Medical University
Conditions:
Effect of Drug
Adverse Drug Event
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief Summary
A multi-center, prospective, randomized, double-blind, no-inferiority clinical trial designed to assess the the safety and efficacy of remazolam besylate in sedation of critically ill mechanically ven...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 20 2026
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT06575530
Start Date
January 20 2025
End Date
June 20 2026
Last Update
January 7 2026
Active Locations (1)
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1
Beijing Shijitan Hospital.CMU
Beijing, Beijing Municipality, China, 100038