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瑞米唑仑-氟马西尼与丙泊酚用于人工流产手术全身麻醉后对精神运动功能及苏醒影响的比较:一项随机对照试验

Comparison of Remimazolam-Flumazenil and Propofol on Psychomotor Function and Emergence Following General Anesthesia in Surgical Abortion: A Randomized Controlled Trial.

作者信息

Gu Jinye, Liu Yang, Lin Xiaoyan, Fu Lei, Liu Jianbo, Sun Bona, Li Xiaoyu, Lu Bo

机构信息

Department of Anesthesiology, Zhenhai Hospital of Traditional Chinese Medicine, Ningbo, 315200, People's Republic of China.

Department of Gynaecology, Zhenhai Hospital of Traditional Chinese Medicine, Ningbo, 315200, People's Republic of China.

出版信息

Drug Des Devel Ther. 2024 Dec 30;18:6447-6457. doi: 10.2147/DDDT.S486892. eCollection 2024.

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 (=50.61, >0.05, ²=0.0051). The TDT results were also comparable between the groups at all time points (=0.12, 0.11 and 0.30, all >0.05, =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 (<0.05). The Remimazolam group showed significantly shorter times to first eye opening (54.48±3.45 s vs 99.22±11.78 s, =0.0014, =5.15) and to obey verbal commands (61.85±3.78 s vs 131.1±12.79 s, <0.0001, =7.34) compared to the Propofol group.The incidence of injection pain and respiratory depression was significantly lower in the remimazolam group (<0.05), while hiccups were more common. Hemodynamic stability was maintained in both groups, with no significant differences in blood pressure or oxygen saturation (>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.

摘要

目的

本研究旨在比较瑞马唑仑联合氟马西尼与丙泊酚用于无痛人工流产患者时的恢复情况,重点关注精神运动功能和苏醒情况。快速恢复和精神运动功能的恢复对于提高人工流产等门诊手术患者的安全性和满意度至关重要。

方法

总共110例计划行人工流产的患者按1:1比例随机分为瑞马唑仑组(R组)和丙泊酚组(P组)。两组均静脉注射舒芬太尼诱导麻醉,随后分别给予瑞马唑仑或丙泊酚。麻醉后30、60和90分钟使用数字符号替换测验(DSST)和特里尔点阵测验(TDT)评估精神运动功能。记录苏醒参数,包括首次睁眼时间和首次言语反应时间。同时监测不良事件和血流动力学参数。

结果

瑞马唑仑组和丙泊酚组麻醉后30、60和90分钟的DSST评分相似(=50.61,>0.05,²=0.0051)。两组在所有时间点的TDT结果也相当(=0.12、0.11和0.30,均>0.05,=0.0002、0.0003和0.0008)。麻醉后30或60分钟时,两组的DSST评分或TDT表现均显著低于术前基线,表明精神运动功能下降(<0.05)。与丙泊酚组相比,瑞马唑仑组首次睁眼时间(54.48±3.45秒对99.22±11.78秒,=0.0014,=5.15)和对言语指令的反应时间(61.85±3.78秒对131.1±12.79秒,<0.0001,=7.34)显著缩短。瑞马唑仑组注射痛和呼吸抑制的发生率显著更低(<0.05),而呃逆更常见。两组均维持血流动力学稳定,血压和血氧饱和度无显著差异(>0.05)。

结论

在无痛人工流产患者中,瑞马唑仑联合氟马西尼的苏醒速度更快,精神运动功能与丙泊酚相当。这种联合用药为需要快速恢复且术后并发症最少的手术提供了有前景的麻醉方案。

试验注册

ChiCTR2300075375,注册日期:2023年9月3日。

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