Remimazolam reduces State-Trait Anxiety Inventory-State Scale scores in hemorrhoid surgery with spinal-epidural anesthesia: A randomized trial

doi:10.4240/wjgs.v17.i9.110034

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World Journal of Gastrointestinal Surgery

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1948-9366

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Randomized Controlled Trial

World J Gastrointest Surg. Sep 27, 2025; 17(9): 110034
Published online Sep 27, 2025. doi: 10.4240/wjgs.v17.i9.110034

Remimazolam reduces State-Trait Anxiety Inventory-State Scale scores in hemorrhoid surgery with spinal-epidural anesthesia: A randomized trial

Tao Hu, Qian Huang, Lai Wei, Shi Zhong, Jing Wang

Tao Hu, Qian Huang, Lai Wei, Shi Zhong, Department of Anesthesiology, Hunan Provincial People’s Hospital, The First Affiliated Hospital of Hunan Normal University, Changsha 410011, Hunan Province, China

Tao Hu, Jing Wang, Department of Anesthesiology, The Second Xiangya Hospital, Central South University, Changsha 410011, Hunan Province, China

Co-corresponding authors: Shi Zhong and Jing Wang.

Author contributions: Zhong S and Wang J were responsible for the study conception and design, data analysis and interpretation and ensuring ethical compliance and methodological rigor. Hu T handled sample collection, analysis, data entry, and outlier screening. Huang Q prepared the blinded medications following strict SOPs. Wei L assisted in data validation, cross-checked with original records, and contributed to statistical analysis. Hu T and Wang J co-drafted the manuscript, with Hu T detailing methods and Wang J integrating literature. They refined figures together. All authors critically reviewed, debated results, and unanimously approved the manuscript for submission.

Supported by the Health Commission of Hunan Province, No. 202204115263; and the Fundamental Research Funds for the Central Universities of Central South University, No. 2024XQLH027.

Institutional review board statement: The Institutional Review Board of The First Affiliated Hospital of Hunan Normal University approved the study (version 3.0, dated 2022-05-21), No.[2022]-51.

Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.

Conflict-of-interest statement: All authors report no relevant conflicts of interest for this article.

CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.

Data sharing statement: Technical appendix, statistical code and dataset available from the corresponding author at 506858@csu.edu.cn. Participants gave informed consent for data sharing.

Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/

Corresponding author: Jing Wang, MD, Department of Anesthesiology, The Second Xiangya Hospital, Central South University, No. 139 Renmin Middle Road, Changsha 410011, Hunan Province, China. 506858@csu.edu.cn

Received: May 28, 2025
Revised: June 30, 2025
Accepted: August 4, 2025
Published online: September 27, 2025
Processing time: 119 Days and 16.8 Hours

Abstract

BACKGROUND

In the field of anesthesia for procedure for prolapse and hemorrhoids (PPH) surgery, combined spinal-epidural (CSE) anesthesia has been a common approach. However, exploring new combinations to optimize patient outcomes remains crucial. Remimazolam, a short-acting benzodiazepine, shows potential for improving sedation and reducing patient anxiety. The effects of combining remimazolam with CSE anesthesia, compared to traditional CSE anesthesia alone, on patient anxiety, sedation depth, and hemodynamics during PPH surgery have not been fully elucidated.

AIM

To compare remimazolam-CSE vs CSE alone on State-Trait Anxiety Inventory-State scale (STAI-S) scores, sedation, and hemodynamics in PPH surgery.

METHODS

This study is a single-center, prospective, randomized controlled trial. Between November 23, 2022, and August 6, 2024, 60 eligible patients were randomly assigned to the CSE anesthesia group or the remimazolam-combined CSE anesthesia group (30 patients each). STAI-S scores, Ramsay sedation scores, and hemodynamic parameters (systolic blood pressure, diastolic blood pressure, heart rate) were measured at multiple time points. Two-way mixed-effects ANOVA and post-hoc analyses were performed.

RESULTS

The Combined group demonstrated significantly lower STAI-S scores before leaving the operating room [mean: 28.80 vs 54.03, mean difference (95%CI): 25.23 (21.24-29.23), P < 0.001] and 24 hours post-operation [mean: 45.07 vs 54.53, mean difference (95%CI): 9.47 (6.29-12.64), P < 0.001] than the CSE group. Moreover, the Combined group achieved a deeper sedation level during intraoperative maintenance [median: 5.00 (IQR: 5.00-5.00) vs 2.00 (IQR: 2.00-2.00); median difference (95%CI): 3.00 (3.00-3.00), P < 0.001]. Regarding hemodynamics, a significant inter-group difference in systolic blood pressure was observed at the start of the surgery [mean: 128.8 vs 114.7 for the Combined and CSE groups, mean difference (95%CI): 14.17 (0.77-27.57), adjusted P = 0.033].

CONCLUSION

Remimazolam-combined anesthesia outperformed CSE anesthesia in reducing STAI-S scores, enhancing intraoperative sedation, and stabilizing systolic blood pressure at a critical stage, indicating its superiority in perioperative management.

Keywords: Procedure for prolapse and hemorrhoids surgery; Combined spinal-epidural anesthesia; Remimazolam-based combined anesthesia; State-Trait Anxiety Inventory-State Scale scores; Sedation depth; Hemodynamics

Core Tip: In procedure for prolapse and hemorrhoids (PPH) surgery, traditional combined spinal-epidural (CSE) anesthesia commonly encounters challenges of insufficient intraoperative sedation and hemodynamic fluctuations. This study confirms that a remimazolam-based CSE anesthesia protocol significantly reduces patient anxiety before leaving the operating room and at 24 hours post-operation, while achieving deep sedation and stabilizing systolic blood pressure during critical surgical phases. The rapid onset of remimazolam's sedative effect and its anxiolytic properties offer an optimized approach to perioperative management of CSE anesthesia in PPH surgery.