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经导管膜周部室间隔缺损(VSD)封堵术的儿科患者中,鼻内给予右美托咪定与鼻内给予咪达唑仑作为标准治疗的比较:一项随机对照试验。

Intranasal dexmedetomidine versus intranasal midazolam as a standard of care for pediatric patients undergoing transcatheter perimembranous ventricular septal defect (VSD) closure: a randomized controlled trial.

作者信息

Shorbagy Mohammed Saed, Mahrose Ramy, Kasem Amr A, Ali Yasmin Abdelrazik, Abdelaziz Sally Hamdy

机构信息

Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

出版信息

Anaesthesiol Intensive Ther. 2025 Jun 17;57(1):115-120. doi: 10.5114/ait/200231.

Abstract

INTRODUCTION

Sedative premedication may hold notable significance in pediatric patients undergoing diagnostic and interventional cardiac catheterization, as it minimizes anxiety, facilitates parental separation, and allows for the acceptance of inhalational induction. The intranasal route is a reliable method for administering sedatives as pre- medication in pediatric patients. This study compared and evaluated the sedative effects of intranasal dexmedetomidine versus intranasal midazolam as premedication in pediatric patients undergoing transcatheter closure of ventricular septal defects.

MATERIAL AND METHODS

This prospective, randomized, double-blind study included 40 pediatric patients aged 3 to 6 years scheduled for transcatheter perimembranous VSD closure under general anesthesia. The subjects were randomly assigned to receive either intranasal midazolam at 0.2 mg kg body mass or intranasal dexmedetomidine at 0.5 μg kg body mass. The primary outcome measured was the effect of preoperative sedatives on the Ramsay sedation score. Secondary outcomes included the child-parent separation score, child emergence agitation level, effects on hemodynamics, and oxygen saturation.

RESULTS

This study included 40 individuals with similar demographic profiles and comparable duration of the procedure ( = 0.152) in both groups. No statistically significant differences were detected in the Ramsay sedation score ( = 0.582), child-parent separation score ( = 1.000) 20 minutes after drug administration, or postoperative child emergence agitation level ( = 0.351). No statistically significant difference was observed in terms of blood pressure, heart rate and oxygen saturation between the two groups.

CONCLUSIONS

Pediatric patients were successfully and effectively sedated with both intranasal dexmedetomidine and intranasal midazolam, with stable hemodynamics and oxygen saturation.

摘要

引言

镇静术前用药对于接受诊断性和介入性心导管检查的儿科患者可能具有显著意义,因为它可最大程度减少焦虑、便于患儿与家长分离,并有助于接受吸入诱导麻醉。鼻内途径是在儿科患者中作为术前用药给予镇静剂的可靠方法。本研究比较并评估了在接受室间隔缺损经导管封堵术的儿科患者中,鼻内给予右美托咪定与鼻内给予咪达唑仑作为术前用药的镇静效果。

材料与方法

这项前瞻性、随机、双盲研究纳入了40例年龄在3至6岁、计划在全身麻醉下进行经导管膜周部室间隔缺损封堵术的儿科患者。受试者被随机分配接受按体重0.2 mg/kg的鼻内咪达唑仑或按体重0.5 μg/kg的鼻内右美托咪定。测量的主要结局是术前镇静剂对拉姆齐镇静评分的影响。次要结局包括患儿与家长分离评分、患儿苏醒期躁动水平、对血流动力学的影响以及血氧饱和度。

结果

本研究纳入了40名个体,两组患者的人口统计学特征相似,手术持续时间相当(P = 0.152)。给药20分钟后的拉姆齐镇静评分(P = 0.582)、患儿与家长分离评分(P = 1.000)或术后患儿苏醒期躁动水平(P = 0.351)均未检测到统计学显著差异。两组之间在血压、心率和血氧饱和度方面未观察到统计学显著差异。

结论

鼻内给予右美托咪定和鼻内给予咪达唑仑均成功且有效地使儿科患者镇静,血流动力学和血氧饱和度稳定。

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