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小剂量阿芬太尼有效降低全身麻醉下小儿患者意识消失时瑞马唑仑的半数有效剂量:一项采用序贯上下分配法的研究

Low-Dose Alfentanil Effectively Reduces the ED50 of Remimazolam for Loss of Consciousness in Pediatric Patients Undergoing General Anesthesia: A Study Using Up-and-Down Sequential Allocation Method.

作者信息

Shi Xinyuan, Yi Fuxia, Xiao Hongyi, Yu Shiyu, Sun Xiaohan, Wei Yaxin, Yue Fangli, Ji Fanceng

机构信息

School of Anaesthesiology,Shandong Second Medical University, Weifang, People's Republic of China.

Department of Anaesthesiology,Weifang People's Hospital, Weifang, People's Republic of China.

出版信息

Drug Des Devel Ther. 2025 Aug 29;19:7459-7466. doi: 10.2147/DDDT.S532565. eCollection 2025.

Abstract

PURPOSE

To investigate the effects of low-dose alfentanil on the 50% effective dose (ED)/95% effective dose (ED) of remimazolam for successful loss of consciousness during general anesthesia in pediatric patients.

PATIENTS AND METHODS

Fifty-two pediatric patients (aged 3-12, ASA I-II) scheduled for elective surgery were divided into two groups: Group A (n=24;alfentanil 5 μg kg + remimazolam 0.1 mg kg) and Group C (n=28;saline + remimazolam 0.15 mg kg). The MOAA/S scale was employed for assessment. To calculate the ED50, ED95 of remimazolam for inducing loss of consciousness in pediatric patients undergoing general anesthesia. Record the monitored values (MAP, HR, SpO) at different time points and the incidence of injection pain, hiccups, spontaneous movements, hypotension, bradycardia, respiratory depression, and overall adverse events.

RESULTS

In Group A, the ED of remimazolam for loss of consciousness in pediatric patients was 0.212 mg kg (95% CI: 0.182 - 0.242 mg kg), significantly lower than that in Group C (0.340 mg kg, 95% CI: 0.295-0.388 mg kg, P <0.001). Similarly, the ED in Group A was 0.265 mg kg (95% CI: 0.237-0.413 mg kg), significantly lower than that in Group C (0.434 mg kg, 95% CI: 0.387-0.737 mg kg, P <0.001). The overall incidence of adverse reactions was 8.3% in Group A, significantly lower than the 39.3% in Group C (P = 0.012). Compared with baseline values at T0, the MAP of pediatric patients in both groups decreased at T2 (P<0.05), but the reduction remained within 20% of the baseline values.

CONCLUSION

Low-dose alfentanil (5 μg kg) significantly reduces the ED and ED of remimazolam for successful loss of consciousness during paediatric general anaesthesia induction and decreases the incidence of adverse reactions during remimazolam induced sedation.

摘要

目的

探讨小剂量阿芬太尼对小儿患者全身麻醉诱导时瑞米唑仑意识消失的半数有效剂量(ED50)/95%有效剂量(ED95)的影响。

患者与方法

52例择期手术的小儿患者(年龄3 - 12岁,ASA I-II级)分为两组:A组(n = 24;阿芬太尼5 μg/kg + 瑞米唑仑0.1 mg/kg)和C组(n = 28;生理盐水 + 瑞米唑仑0.15 mg/kg)。采用MOAA/S量表进行评估。计算小儿全身麻醉诱导时瑞米唑仑意识消失的ED50、ED95。记录不同时间点的监测值(MAP、HR、SpO)以及注射痛、呃逆、自主运动、低血压、心动过缓、呼吸抑制和总体不良事件的发生率。

结果

A组小儿患者意识消失时瑞米唑仑的ED50为0.212 mg/kg(95%CI:0.182 - 0.242 mg/kg),显著低于C组(0.340 mg/kg,95%CI:0.295 - 0.388 mg/kg,P <0.001)。同样,A组的ED95为0.265 mg/kg(95%CI:0.237 - 0.413 mg/kg),显著低于C组(0.434 mg/kg,95%CI:0.387 - 0.737 mg/kg,P <0.001)。A组不良反应总发生率为8.3%,显著低于C组的39.3%(P = 0.012)。与T0时的基线值相比,两组小儿患者的MAP在T2时均下降(P<0.05),但下降幅度仍在基线值的20%以内。

结论

小剂量阿芬太尼(5 μg/kg)显著降低小儿全身麻醉诱导时瑞米唑仑意识消失的ED50和ED95,并降低瑞米唑仑诱导镇静期间的不良反应发生率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2fbc/12405720/9291a8fe8e5d/DDDT-19-7459-g0001.jpg

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