Short-term postoperative neurocognitive safety and recovery profiles of remimazolam tosilate combined with flumazenil vs. propofol in cirrhotic patients undergoing endoscopic variceal treatment: a randomized controlled trial.

BACKGROUND: Patients with liver cirrhosis frequently exhibit compromised drug metabolism due to hepatic dysfunction, which significantly increases their susceptibility to postoperative neurological adverse events. This study aimed to evaluate the impact of remimazolam tosilate combined with flumazenil on early postoperative neurocognitive function and recovery quality in cirrhotic patients undergoing endoscopic variceal ligation (EVL) and/or endoscopic variceal sclerotherapy (EVS), so as to provide evidence-based guidance for optimizing clinical anesthesia management. METHODS: A total of 108 cirrhotic patients scheduled for EVL and/or EVS were randomly assigned to the propofol group (Group P, n = 54) or the remimazolam tosilate group (Group R, n = 54). The primary outcomes were defined as performance on the Number Connection Test-A (NCT-A) and the Digit Symbol Test (DST), evaluated at baseline (preoperatively) and at 6 and 24 h following surgery. Secondary endpoints included the time to spontaneous respiration, time to eye opening, time to commanded response, and time to extubation. Furthermore, the modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores and modified Steward scores were assessed at multiple post-extubation time points. RESULTS: No statistically significant differences were observed in NCT-A and DST scores between the two groups at baseline, 6 h postoperatively, or 24 h postoperatively (P > 0.05). Relative to preoperative baseline levels, the NCT-A completion time was significantly reduced, while DST scores were significantly increased at 24 h postoperatively in both groups (P < 0.05). Regarding the quality of recovery, the times to spontaneous respiration, eye opening, commanded response, and extubation were significantly shorter in Group R compared to Group P (P < 0.01). Furthermore, at the time of extubation (T0), the modified MOAA/S and Steward scores were significantly higher in Group R compared to Group P (P < 0.05). CONCLUSION: In cirrhotic patients undergoing endoscopic variceal ligation or sclerotherapy, the administration of remimazolam tosilate with flumazenil demonstrated comparable early postoperative neurocognitive performance to propofol, while significantly shortening recovery time and enhancing the quality of extubation and emergence. Consequently, this regimen represents a neurologically safe (with regard to short-term cognitive outcomes), rapidly controllable, and clinically feasible anesthetic option for this high-risk population. CLINICAL TRIALS REGISTRATION: this study was registered on https://www.chictr.org.cn, (ChiCTR2200066161).