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探讨瑞马唑仑用于小儿斜视矫正手术全身麻醉下喉罩置入的 ED50 和 ED95。

Exploring the ED50 and ED95 of Remimazolam for Laryngeal Mask Airway Insertion During General Anesthesia in Pediatric Strabismus Correction Surgery.

机构信息

Department of Anesthesiology, Ningbo No.2 Hospital, 315000 Ningbo, Zhejiang, China.

Department of Ophthalmology, Ningbo Aier Guangming Eye Hospital, 315020 Ningbo, Zhejiang, China.

出版信息

Ann Ital Chir. 2024;95(4):690-698. doi: 10.62713/aic.3430.

DOI:10.62713/aic.3430
PMID:39186343
Abstract

AIM

Remimazolam, known for its rapid onset, quick metabolism, and short recovery time from sedation, offers significant advantages in clinical anesthesia. Previous studies have primarily investigated its application in adult surgical anesthesia, with less focus on its utilization in pediatric patients. Therefore, we aimed to explore the 50% effective dose (ED50) and 95% effective dose (ED95) of remimazolam for laryngeal mask airway (LMA) insertion during general anesthesia in pediatric strabismus correction surgery and investigate its dose-response relationship, thereby providing valuable reference data for safer and more rational clinical use of remimazolam.

METHODS

This study included 32 patients aged 3-12 years undergoing strabismus correction surgery at Ningbo Aier Guangming Eye Hospital in 2024. The dosage of remimazolam was determined according to the Dixon 'up-and-down' sequential method: the starting induction dose was 0.2 mg/kg, with a step dose of 0.05 mg/kg. In cases of positive anesthetic effect, the subsequent patient received a reduced step dose, while in cases of negative anesthetic effect, the next subject received an increased step dose. The trial was terminated upon observing seven "positive-negative" crossover points. Furthermore, the ED50 and ED95, along with their 95% confidence intervals (95% CI) were calculated using the Probit regression analysis. Additionally, vital signs of the patients, such as peripheral oxygen (SpO2), heart rate, and blood pressure, along with the incidence of adverse events, were monitored.

RESULTS

The ED50 of remimazolam for LMA insertion in pediatric strabismus correction surgery was 0.300 mg/kg (95% CI 0.276-0.323 mg/kg), and the ED95 was 0.369 mg/kg (95% CI 0.324-0.414 mg/kg). Throughout the surgery, SpO2, heart rate, and blood pressure remained stable without any significant fluctuations.

CONCLUSIONS

The ED50 and ED95 of remimazolam for LMA insertion in pediatric strabismus correction surgery are 0.300 mg/kg and 0.369 mg/kg, respectively. This study demonstrates that remimazolam is both safe and effective for LMA insertion during general anesthesia in pediatric strabismus correction surgery.

摘要

目的

瑞马唑仑具有起效迅速、代谢快速、镇静恢复时间短等特点,在临床麻醉中具有显著优势。既往研究主要集中在其在成人手术麻醉中的应用,而对小儿患者的应用研究较少。因此,本研究旨在探讨瑞马唑仑用于小儿斜视矫正手术全身麻醉时喉罩置入的半数有效剂量(ED50)和 95%有效剂量(ED95),并探讨其剂量反应关系,为瑞马唑仑更安全、更合理的临床应用提供有价值的参考数据。

方法

本研究纳入 2024 年在宁波爱尔光明眼科医院行斜视矫正手术的 3-12 岁患儿 32 例。采用 Dixon“上下”序贯法确定瑞马唑仑的剂量:起始诱导剂量为 0.2mg/kg,步长剂量为 0.05mg/kg。麻醉效果阳性时,下一个患者给予减少的步长剂量,麻醉效果阴性时,下一个患者给予增加的步长剂量。观察到 7 个“阳性-阴性”交叉点后试验结束。采用概率单位回归分析计算 ED50 和 ED95 及其 95%置信区间(95%CI)。同时监测患者的生命体征,如外周血氧(SpO2)、心率和血压,以及不良反应的发生率。

结果

瑞马唑仑用于小儿斜视矫正手术喉罩置入的 ED50 为 0.300mg/kg(95%CI 0.276-0.323mg/kg),ED95 为 0.369mg/kg(95%CI 0.324-0.414mg/kg)。整个手术过程中,SpO2、心率和血压均保持稳定,无明显波动。

结论

瑞马唑仑用于小儿斜视矫正手术喉罩置入的 ED50 和 ED95 分别为 0.300mg/kg 和 0.369mg/kg。本研究表明,瑞马唑仑用于小儿斜视矫正手术全身麻醉时喉罩置入安全有效。

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