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DOI 10.2147/dddt.s532565

Медицинская библиотека · Drug design, development and therapy · 2025

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.

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

СтатьяРандомизированное исследованиеПеревод в очереди

Аннотация

PURPOSE: To investigate the effects of low-dose alfentanil on the 50% effective dose (ED50)/95% effective dose (ED95) 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-1 + remimazolam 0.1 mg kg-1) and Group C (n=28;saline + remimazolam 0.15 mg kg-1). 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, SpO2) 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 ED50 of remimazolam for loss of consciousness in pediatric patients was 0.212 mg kg-1 (95% CI: 0.182 - 0.242 mg kg-1), significantly lower than that in Group C (0.340 mg kg-1, 95% CI: 0.295-0.388 mg kg-1, P <0.001). Similarly, the ED95 in Group A was 0.265 mg kg-1 (95% CI: 0.237-0.413 mg kg-1), significantly lower than that in Group C (0.434 mg kg-1, 95% CI: 0.387-0.737 mg kg-1, 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-1) significantly reduces the ED50 and ED95 of remimazolam for successful loss of consciousness during paediatric general anaesthesia induction and decreases the incidence of adverse reactions during remimazolam induced sedation.

Для цитирования: Shi Xinyuan, Yi Fuxia, Xiao Hongyi, Yu Shiyu, Sun Xiaohan, Wei Yaxin, Yue Fangli, Ji Fanceng. 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.. Drug design, development and therapy. 2025. DOI: 10.2147/dddt.s532565.

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