Combination of remazolam and alfentanil on hemodynamics, postoperative cognitive function, and adverse cardiovascular events in elderly patients undergoing laparoscopic cholecystectomy: a randomized controlled trial.

OBJECTIVE

To evaluate the effects of a remazolam-alfentanil combination versus a propofol-alfentanil combination on intraoperative hemodynamics, postoperative cognitive function, and cardiovascular adverse events in elderly patients undergoing laparoscopic cholecystectomy.

METHODS

This prospective, randomized controlled trial enrolled 116 elderly patients (aged 60-80 years, ASA I-III) undergoing laparoscopic cholecystectomy from January 2022 to June 2023. Patients were randomly assigned (1:1) to receive either remazolam-alfentanil (n = 58) or propofol-alfentanil (n = 58). Primary outcomes included intraoperative hemodynamic parameters (MAP, HR, CO, CI, SVR), cognitive function (MMSE and MoCA scores, and incidence of postoperative delirium [POD]), and incidence of cardiovascular events. Secondary outcomes included recovery times and postoperative VAS and Ramsay scores.

RESULTS

A total of 112 patients (56 per group) completed the study. The remazolam group had significantly shorter times to awakening (10.41 ± 2.09 vs. 12.68 ± 2.73 min), extubation (11.17 ± 2.11 vs. 14.34 ± 2.62 min), and anesthesia duration (22.53 ± 6.66 vs. 28.81 ± 7.05 min) (all P < 0.001). Intraoperatively, the remazolam group showed more stable hemodynamics with higher MAP, HR, CO, and CI (P < 0.05). Postoperative MMSE and MoCA scores were significantly higher on days 3 and 7 (P < 0.05). The incidence of POD at day 7 was significantly lower in the remazolam group (3.6% vs. 16.1%, P = 0.031). The incidence of cardiovascular events was lower in the remazolam group (21.4% vs. 71.4%, P < 0.001), particularly hypotension (7.1% vs. 62.5%) and bradycardia (14.3% vs. 53.6%). VAS and Ramsay scores were also lower at 6 and 12 h postoperatively (P < 0.001).

CONCLUSION

The remazolam-alfentanil combination provided faster recovery, improved hemodynamic stability, better cognitive outcomes, and fewer cardiovascular events than propofol-alfentanil in elderly laparoscopic cholecystectomy patients. While promising, these findings warrant confirmation in larger, multicenter trials.

CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/showproj.html?proj=210389, Identifier ChiCTR2300077536.