Efficacy and Safety of Remazolam Besylate in Patients Requiring Mechanical Ventilation Admitted to ICU After Non-cardiac Surgery: Protocol for a Randomized, Controlled No-inferiority Trial

What this Trial Is About

Researchers are evaluating the safety and effectiveness of remimazolam besylate compared to dexmedetomidine for sedating critically ill patients who require mechanical ventilation after non-cardiac surgery. This randomized, double-blind, no-inferiority clinical trial aims to determine whether remimazolam provides similar sedation quality and safety outcomes as dexmedetomidine in this patient population. Participants will be randomly assigned to receive either remimazolam besylate or dexmedetomidine hydrochloride via continuous intravenous infusion in the ICU following surgery. Sedation depth will be monitored hourly using the Richmond Agitation-Sedation Scale (RASS) to maintain light sedation levels (score 0 to -2). Dosages of sedatives will be adjusted accordingly, and if adequate sedation is not achieved within dosage limits, propofol will be administered as a rescue medication. Remifentanil is also used alongside both sedatives to manage pain. Researchers will assess sedation, weaning, extubation, and outcomes daily during the ICU stay. Participants will undergo regular evaluations including sedation depth, pain scores, delirium incidence, sleep quality, cognitive function, and length of ICU and hospital stay. Outcome measures include ventilation-free days within 28 days, sedation time, extubation timing, re-intubation rates, and mortality at 60 days post-surgery. Safety and efficacy will be closely monitored during ICU admission and follow-up assessments. The total study duration extends through hospital discharge and 60 days after surgery.

Sedation Efficacy and Safety of Remazolam Besylate in Ventilated Surgical Critically Ill Patients