甲苯磺酸瑞马唑仑经鼻滴入用于儿童术前镇静的安全性与有效性研究

Safety and efficacy of remimazolam intranasal infusion for preoperative sedation in children

目的探讨甲苯磺酸瑞马唑仑经鼻滴入用于儿童术前镇静的安全性与有效性研究。方法随机纳入本院2020年8月—2021年3月在全麻下行腺样体或扁桃体切除手术的患儿150例,随机分为B1组、B2组及对照组(C组),每组50例。在麻醉诱导前30 min,B1组经鼻滴入甲苯磺酸瑞马唑仑0.1 mg·kg^(-1),B2组经鼻滴入甲苯磺酸瑞马唑仑0.2 mg·kg^(-1),C组经鼻滴入生理盐水,每组滴鼻容量均为5 mL。比较3组患儿不同时间点的心率(HR)、平均动脉压(MAP)、血氧饱和度(SPO 2)以及镇静有效率、麻醉诱导时间、气管插管和手术开始时脑电双频谱指数(BIS)、拔管时间、苏醒时间、苏醒期躁动评分(PEAD)及术后不良反应发生情况。结果与C组比较,B1组、B2组在滴鼻后10 min的MAP、HR均降低(P<0.05),在手术开始时与手术结束30 min后,B2组患儿心率低于C组(P<0.05),3组患儿SPO 2变化趋势基本一致,均未出现呼吸抑制;镇静有效率B2组(96%)>B1组(86%)>C组(24%),B1、B2组的镇静效果明显高于对照组(P<0.05);气管插管时BIS方面,B1组与B2组均低于C组(P<0.05);B1、B2组麻醉诱导时间、术后拔管及苏醒时间、拔管后30 min的PEAD评分均优于对照组(P<0.05)。3组不良反应发生率比较差异无统计学意义(P>0.05)。结论经鼻滴入瑞马唑仑是一种安全有效、方便易行的儿童术前镇静方法,其镇静效果确切,术中生命体征表现更平稳,不良反应发生率低,术后苏醒状态更佳。

Objective To investigate the safety and efficacy of remimazolam intranasal infusion for preoperative sedation in children.Methods A total of 150 children who underwent adenoidectomy or tonsillectomy under general anesthesia from August 2020 to March 2021 in our hospital were randomly divided into study group(B1 group,B2 group)and control group(C group),with 50 cases in each group.30min before anesthesia induction,group B1 was intranasal injected with 0.1 mg·kg^(-1) of remimazolam,group B2 with 0.2 mg·kg^(-1) of remimazolam,and group C with normal saline.The nasal volume of each group was 5mL.Compare three groups of children with different time points of heart rate(HR),mean arterial pressure(MAP),blood oxygen saturation(SPO 2)and sedative efficiency,anesthesia induction time,at the beginning of endotracheal intubation and surgical bispectral index(BIS),extubation time,recovery time,Psychometric Evaluation of the Pediatric Anesthesia Emergence Delirium Scale(PEAD)and postoperative adverse reactions occur.Results Compared with group C,MAP and HR of group B1 and B2 were decreased at 10min after nasal drip(P<0.05).At the beginning of surgery and 30min after surgery,HR in group B2 was lower than that in group C(P<0.05).SpO 2 variation trend of the three groups was basically the same,indicating respiratory depression.The sedative efficacy were B2 group(96%)and group B1 group(86%)respectively which were significantly higher than that of control group(24%)(P<0.05).During endotracheal intubation,BIS in groups B1 and B2 was lower than that in group C(P<0.05).The time of anesthesia induction,extubation time and recovery time and PEAD score of 30 min after extubationin the study group were better than those in the control group(P<0.05).There was no significant difference in the incidence of adverse reactions between the study group and the control group.Conclusion Remimazolam intranasal infusion is a safe,effective,convenient method for preoperative sedation of children.The sedative effect is definite,the vital signs are more stable,the incidence of adverse reactions is low,and the postoperative recovery is better.