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.