Remimazolam versus propofol for elderly patients undergoing laparoscopic gastrointestinal surgery: a randomized trial concentrating on delirium and hemodynamic stability.

Abstract

Background Postoperative delirium (POD) is a common complication in elderly surgical patients that can impede recovery. While remimazolam offers superior hemodynamic stability compared to propofol, its impact on POD incidence remains unclear. This randomized trial aimed to determine whether two induction doses of remimazolam are more effective than propofol in reducing POD and improving hemodynamic stability in older patients undergoing laparoscopic gastrointestinal surgery. Methods In this prospective trial, 186 patients (aged 60-80 years) were randomized to receive anesthesia induction with remimazolam 0.15 mg/kg (R1), remimazolam 0.3 mg/kg (R2), or propofol 1.5 mg/kg (P). The primary endpoint was the incidence of POD within 5 days post-surgery, assessed using the 3-Minute Diagnostic Interview for Confusion Assessment Method. Secondary endpoints included hemodynamic parameters, recovery times, and adverse events. Results The incidence of POD was 12.9% in the R1 group, 11.3% in the R2 group, and 6.5% in the P group (P = 0.467). Both remimazolam groups exhibited significantly higher mean arterial pressure following induction and intubation (both P < 0.05). Furthermore, remimazolam was associated with a lower incidence of treated hypotension (P = 0.010), fewer bradycardia events (P < 0.001), and reduced vasopressor requirements (P < 0.05). However, the time to loss of consciousness (P < 0.001) and extubation time (P < 0.001) were longer with remimazolam. Conclusions Remimazolam at induction doses of 0.15 mg/kg and 0.3 mg/kg did not reduce the incidence of POD compared with propofol. Nevertheless, the study was not adequately powered to exclude a clinically relevant difference in POD incidence given the substantially lower-than-expected event rate, as no statistically significant between-group difference was detected. In addition, remimazolam at these doses was associated with higher post-induction blood pressure, fewer hypotensive events, and lower vasopressor requirements compared with propofol. Therefore, remimazolam at these induction doses may serve as suitable alternatives for this vulnerable patient population. Clinical trial registration https://www.chictr.org.cn, Chinese Clinical Trial Registry ChiCTR2400082176.