Efficacy and safety of remimazolam for sedation of patients with end-stage renal disease: a prospective, randomized controlled clinical trial

BACKGROUND: Procedural sedation in patients with end-stage renal disease (ESRD) is challenging due to impaired renal function, which affects drug metabolism and increases the risk of adverse events. Remimazolam, a novel ultrashort-acting intravenous sedative, offers rapid onset and clearance independent of renal function, making it a potential alternative to dexmedetomidine for sedation in this patient population. This study aims to compare the efficacy and safety of remimazolam versus dexmedetomidine in ESRD patients undergoing procedural sedation. The primary hypothesis is that remimazolam will demonstrate superior sedation efficacy and a better safety profile, with reduced hemodynamic instability and faster recovery. METHODS: This is a single-center, prospective, observer-blinded, randomized controlled trial (RCT). A total of 80 ESRD patients aged ≥ 18 years scheduled for peritoneal dialysis catheter placement or removal will be randomly assigned to receive either remimazolam or dexmedetomidine. The primary outcome is the sedation success rate, defined as achieving a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤ 1 within 10 min of drug administration. Secondary outcomes include time to sedation, intraoperative movements, the duration of BIS values < 60 or > 80 during anesthesia maintenance, recovery time, the incidence of adverse events, incidence of postoperative nausea and vomiting (PONV), and postoperative pain scores. DISCUSSION: This is the first RCT to directly compare remimazolam and dexmedetomidine for sedation in ESRD patients undergoing procedural sedation. The results of this study will provide valuable insights into optimizing sedation strategies in this high-risk population, potentially improving clinical outcomes by minimizing complications associated with drug metabolism and recovery. TRIAL REGISTRATION: Chinese Clinical Trial Registry. chictr.org.cn ChiCTR2300075278. Registered on August 31, 2023. https://www.chictr.org.cn/showproj.html?proj=205061 .