Comparison of Remimazolam-Flumazenil and Propofol on Psychomotor Function and Emergence Following General Anesthesia in Surgical Abortion: A Randomized Controlled Trial.
Jinye Gu, Yang Liu, Xiaoyan Lin, Lei Fu, Jianbo Liu, Bona Sun, Xiaoyu Li, Bo Lu
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引用次数: 0
Abstract
Objective: This study aims to compare the recovery profiles of remimazolam combined with flumazenil against those of propofol in patients undergoing painless surgical abortion, focusing on psychomotor function and emergence. Rapid recovery and restoration of psychomotor function are critical for enhancing patient safety and satisfaction in outpatient procedures like surgical abortion.
Methods: A total of 110 patients scheduled for surgical abortion were randomly assigned to either the remimazolam group (Group R) or the propofol group (Group P) in a 1:1 ratio. Both groups received intravenous sufentanil for induction, followed by either remimazolam or propofol. Psychomotor function was assessed using the Digit Symbol Substitution Test (DSST) and Trieger Dot Test (TDT) at 30, 60, and 90 minutes post-anesthesia. Emergence parameters, including time to first eye opening and first verbal response, were recorded. Adverse events and hemodynamic parameters were also monitored.
Results: The DSST scores at 30, 60, and 90 minutes post-anesthesia were similar between the Remimazolam group and the Propofol group (F=50.61, P>0.05, η²=0.0051). The TDT results were also comparable between the groups at all time points (F=0.12, 0.11 and 0.30, all P>0.05, η²=0.0002, 0.0003 and 0.0008). At 30 or 60 minutes post-anesthesia, DSST scores or TDT performance were significantly worse compared to preoperative baseline in both groups, indicating reduced psychomotor function (P<0.05). The Remimazolam group showed significantly shorter times to first eye opening (54.48±3.45 s vs 99.22±11.78 s, P=0.0014, Cohen's d=5.15) and to obey verbal commands (61.85±3.78 s vs 131.1±12.79 s, P<0.0001, Cohen's d=7.34) compared to the Propofol group.The incidence of injection pain and respiratory depression was significantly lower in the remimazolam group (P<0.05), while hiccups were more common. Hemodynamic stability was maintained in both groups, with no significant differences in blood pressure or oxygen saturation (P>0.05).
Conclusion: Remimazolam combined with flumazenil provides faster emergence and comparable psychomotor function to propofol in patients undergoing painless surgical abortion. This combination offers a promising anesthetic profile for procedures requiring quick recovery and minimal postoperative complications.
Trial registration: ChiCTR2300075375, date of registration: 03/09/2023.
目的：比较雷马唑仑联合氟马西尼与异丙酚对无痛手术流产患者的恢复情况，重点关注精神运动功能和产出率。快速恢复和恢复精神运动功能是提高病人安全和满意度的门诊手术，如手术流产。方法：将110例手术流产患者按1:1的比例随机分为雷马唑仑组（R组）和异丙酚组（P组）。两组均静脉注射舒芬太尼进行诱导，随后使用雷马唑仑或异丙酚。在麻醉后30,60和90分钟，采用数字符号替代测试（DSST）和触发点测试（TDT）评估精神运动功能。记录急救参数，包括第一次睁开眼睛的时间和第一次口头反应。同时监测不良事件和血流动力学参数。结果：麻醉后30min、60min、90min，雷咪唑仑组与异丙酚组DSST评分差异无统计学意义（F=50.61, P < 0.05, η²=0.0051）。各组TDT结果在各时间点具有可比性（F=0.12、0.11和0.30，P均为0.05,η²=0.0002、0.0003和0.0008）。麻醉后30或60分钟，两组患者的DSST评分或TDT表现均明显低于术前基线，表明与异丙酚组相比，精神运动功能（PP=0.0014, Cohen’s d=5.15）和口头命令服从能力（61.85±3.78 s vs 131.1±12.79 s, PCohen’s d=7.34）下降。雷马唑仑组注射痛和呼吸抑制发生率明显低于对照组（p < 0.05）。结论：雷马唑仑联合氟马西尼对无痛手术流产患者的苏醒速度更快，精神运动功能与异丙酚相当。这种组合为需要快速恢复和最小术后并发症的手术提供了有希望的麻醉概况。试验注册：ChiCTR2300075375，注册日期：2023年9月3日。
期刊介绍：
Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications.
The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas.
Specific topics covered by the journal include:
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Phenotypic screening and target deconvolution
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Mechanisms of action and signalling pathways
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Gene therapy, cell therapy and immunotherapy
Personalized medicine and pharmacogenomics
Clinical drug evaluation
Patient safety and sustained use of medicines.
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