Comparing Remimazolam Besylate and Dexmedetomidine for Sedation After Non-Cardiac Surgery in Patients Needing Mechanical Ventilation

What this Trial Is About

This clinical trial is a multi-center, randomized, double-blind study conducted in China to compare the sedative effects and safety of remimazolam besylate versus dexmedetomidine in patients who require mechanical ventilation after non-cardiac surgery. The trial aims to determine if remimazolam besylate is not less effective than dexmedetomidine in maintaining sedation. Patients included are adults aged 18 to 64 years undergoing elective non-cardiac surgery and admitted to the ICU with planned mechanical ventilation for more than 24 hours. Participants are randomly assigned to receive either remimazolam besylate or dexmedetomidine via intravenous infusion upon ICU admission. Sedation levels are adjusted hourly to maintain a target RASS score between 0 and -2, with remifentanil co-administered for pain control. If sedation goals are not met, a rescue protocol using propofol boluses and continuous infusion is implemented. The study measures sedation effectiveness over an average of three days in the ICU. During the study, participants will have their sedation levels, pain scores, delirium incidence, ventilation status, and sleep quality monitored closely. Additional outcomes include extubation timing, reintubation rates, oxygen therapy needs, cognitive assessments at 60 days post-surgery, length of ICU and hospital stay, and mortality. Safety and overall recovery will be assessed through these detailed evaluations, with participation lasting until hospital discharge and follow-up assessments at 60 days after surgery.

Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation