中国临床药理学杂志2026，Vol.42Issue(1)：22-27,6.DOI:10.13699/j.cnki.1001-6821.2026.01.004
瑞马唑仑联合芬太尼用于小儿腹腔镜疝气手术全身麻醉的临床研究
Clinical trial of remimazolam combined with fentanyl in general anesthesia for pediatric laparoscopic hernia repair surgery
摘要
Abstract
Objective To observe the clinical efficacy and safety of remimazolam injection combined with fentanyl injection in the induction of general anesthesia for pediatric laparoscopic hernia surgery.Methods The children who underwent elective laparoscopic hernia surgery in our hospital were divided into successful sedation group and failed sedation group according to whether laryngeal mask placement was completed under sedation remedy.Remimazolam injection was administered intravenously,using an initial dose of 0.3 mg·kg-1 with a dose increment of 0.05 mg·kg-1.The dose for the next patient was determined according to the modified Dixon sequential method.Patients who successfully underwent laryngeal mask insertion were included in the sedation success group,while those requiring additional intravenous propofol for sedation to complete laryngeal mask insertion were included in the sedation failure group.Remimazolam injection combined with fentanyl injection was calculated by modified Probit regression for the induction of half effective dose(ED50)and 95％effective dose(ED95)and its 95％confidence interval(CI)in pediatric laparoscopic hernia induction of general anesthesia.Recorded vital signs during anesthesia induction,preoperative,dosage and intraoperative procedures,and evaluated for safety.Results A total of 42 children who were planned for laparoscopic hernia surgery were screened in this study,of which were excluded due to abnormal preoperative examination(4 cases),parental refusal to participate(2 cases)and difficult airway(1 case),and finally,35 hospitalized children who met the criteria were included.All enrolled children successfully completed the study process and no case dropped out,18 cases of successful sedation and 17 cases of failed sedation.The ED50 of remimazolam combined with fentanyl for general anesthesia induction in pediatric laparoscopic surgery was 0.22 mg·kg-1,CI was(0.19～0.26),ED95 was 0.32 mg·kg-1,and CI was(0.28～0.51).The time from anesthesia induction to intubation in the successful and failed sedation groups were 4.58(3.00,5.00)and 4.63(3.25,5.75)min,respectively;the time of surgery were 13.63(7.00,17.00)and 14.00(6.50,18.00)min,respectively;the time from discontinuation to extubation were 17.84(7.00,21.00)and 16.50(6.40,22.75)min,respectively;and the stay time after resuscitation were 38.42(30.00,40.00)and 41.56(22.10,49.25)min,respectively.There was no significant difference between the above indicators in the successful sedation group and the failed sedation group(all P＞0.05).The main adverse drug reactions in the successful sedation group were drowsiness,hypotension and hypoxemia,and in the sedation failure group were drowsiness and hypotension.The total incidence of adverse drug reactions in the successful sedation group and the failed sedation group were 22.22％(4 cases/18 cases)and 17.65％(3 cases/17 cases).There was no significant difference between the above indicators in the successful sedation group and the failed sedation group(P＞0.05).Conclusion The ED50 of remimazolam combined with fentanyl for inserting a laryngeal mask in pediatric general anesthesia is 0.22 mg·kg-1,with a CI of(0.19～0.26).关键词
瑞马唑仑注射液/半数有效量/小儿全身麻醉/腹腔镜疝气手术Key words
remimazolam injection/median effective dose/pediatric general anesthesia/laparoscopic hernia surgery分类
医药卫生引用本文复制引用
李茹,金啸..瑞马唑仑联合芬太尼用于小儿腹腔镜疝气手术全身麻醉的临床研究[J].中国临床药理学杂志,2026,42(1):22-27,6.基金项目
浙江省医药卫生科技计划基金资助项目(2022KY1159) （2022KY1159）
