Your new experience awaits. Try the new design now and help us make it even better

CLINICAL TRIAL article

Front. Pharmacol.

Sec. Translational Pharmacology

Volume 16 - 2025 | doi: 10.3389/fphar.2025.1653593

Combination of Remazolam and Alfentanil on Hemodynamics, Postoperative Cognitive Function, and Adverse Cardiovascular Events in Elderly Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Provisionally accepted
Chaolei  LiuChaolei LiuJin  LiJin LiJunna  HeJunna HeJingjing  ZhangJingjing ZhangLijun  BoLijun BoJiaojiao  YangJiaojiao YangYuan  MaYuan MaJianzhang  QinJianzhang QinYanjie  YangYanjie YangZhangnan  SunZhangnan Sun*
  • Second Hospital of Hebei Medical University, Shijiazhuang, China

The final, formatted version of the article will be published soon.

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 hours 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.

Keywords: Remazolam, Propofol, Alfentanil, laparoscopic cholecystectomy, Hemodynamics, postoperative cognitive dysfunction, postoperative delirium, Adverse cardiovascular events

Received: 25 Jun 2025; Accepted: 29 Sep 2025.

Copyright: © 2025 Liu, Li, He, Zhang, Bo, Yang, Ma, Qin, Yang and Sun. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Zhangnan Sun, sunznszn@outlook.com

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.