全身麻醉下儿童腹部手术右美托咪定最佳给药剂量的随机对照研究

Randomized controlled study on the optimal dosage of dexmedetomidine in pediatric abdominal surgery under general anesthesia

目的探讨全身麻醉(全麻)下儿童腹部手术右美托咪定的最佳给药剂量。方法本研究为前瞻性、单中心、随机对照试验。研究对象为2019年11月到2020年12月在空军军医大学第一附属医院行全麻腹部手术的患儿。采用随机数表法将患儿随机分为右美托咪定0.4μg、0.7μg和1.0μg 3个剂量组,在麻醉诱导前15 min分别按右美托咪定0.4μg/kg、0.7μg/kg和1.0μg/kg剂量静脉泵注,其他麻醉方法相同。比较3组患儿手术期间心率和平均血压(MBP),麻醉苏醒后Ramsay镇静评分、镇静-躁动评分(SAS)、儿童疼痛行为量表评分(FLACC)和术后24 h不良反应发生情况。结果共有150例患儿纳入研究,其中男性77例(51.3%),女性73例(48.7%);年龄(7±1)岁,体重(22.4±4.6)kg。手术治疗的疾病包括腹股沟疝81例(54.0%),鞘膜积液36例(24.0%),隐睾19例(12.7%),阑尾炎14例(9.3%)。150例患儿随机分为右美托咪定0.4μg组、0.7μg组和1.0μg组,每组50例患儿。3组患儿的性别、年龄、体重、美国麻醉医师协会分级和分离焦虑的差异均无统计学意义(均P>0.05)。1.0μg组较0.4μg组术后苏醒时间[(12±3)min比(9±3)min]和拔管时间[(12±3)min比(9±3)min]均明显延长,差异均有统计学意义(均P<0.001);1.0μg组与0.7μg组、0.7μg组与0.4μg组比较的差异均无统计学意义(均P>0.05)。手术期间0.7μg组和1.0μg组患儿的心率和MBP均明显低于0.4μg组(均P<0.001)。0.7μg组和1.0μg组患儿麻醉苏醒即刻、离开复苏室即刻和术后1 h的Ramsay镇静评分均明显高于0.4μg组,而SAS评分和FLACC评分均明显低于0.4μg组,差异均有统计学意义(均P<0.05)。0.7μg组和1.0μg组与0.4μg组相比,术后躁动[12.0%(6/50)和8.0%(4/50)比30.0%(15/50)]及总体不良反应发生率[22.0%(11/50)和16.0%(8/50)比44.0%(22/50)]均明显降低(均P<0.05)。结论儿童全麻下腹部手术麻醉诱导前给予右美托咪定0.7μg/kg对麻醉苏醒影响较小,且镇静效果良好,不良反应发生率低,为最佳的给药剂量。

Objective To explore the optimal dosage of dexmedetomidine for pediatric abdominal surgery under general anesthesia.Methods The study was designed as a prospective,single center,randomized controlled trial.Children who underwent abdominal surgery under general anesthesia in the First Affiliated Hospital of Air Force Military Medical University from November 2019 to December 2020 were enrolled and randomly divided into 3 groups according to dexmedetomidine dose(0.4μg,0.7μg,and 1.0μg)using the random number table method.Dexmedetomidine at corresponding dose were given by intra‑venous pump 15 minutes before anesthesia induction at bases of the same other anesthesia methods.The heart rate and mean blood pressure during surgery,Ramsay sedation score,sedative‑agitation score(SAS),and the face‑legs‑activity‑cry‑consolability behavioral tool(FLACC)after awakening from anesthesia,and adverse reactions within 24 hours after surgery were compared in children among the 3 groups.Results A total of 150 children were entered in the study,including 77 males(51.3%)and 73 females(48.7%),aged(7±1)years with weight of(22.4±4.6)kg.The surgeries were performed for inguinal hernia,hydrocele,crypt‑orchidism,and appendicitis in 81(54.0%),36(24.0%),19(12.7%),and 14(9.3%)children,respectively.The 150 children were randomly divided into dexmedetomidine 0.4μg group,0.7μg group,and 1.0μg group,with 50 children in each group.There were no statistically significant differences in gender,age,weight,American Society of Anesthesiologists grade,or separation anxiety among children of the 3 groups(all P>0.05).The postoperative recovery time[(12±3)min vs.(9±3)min]and time to extubation[(12±3)min vs.(9±3)min]of children in the 1.0μg group were significantly longer than those in the 0.4μg group(both P<0.001).While the differences of the 2 indexes above in children were not significantly when compared between the 1.0 and 0.7μg groups and the 0.7 and 0.4μg groups(all P>0.05).During the operation,the heart rate and MBP of children in the 0.7μg group and the 1.0μg group were significantly lower than those in the 0.4μg group(both P<0.001).The Ramsay sedation scores of children when awakening from anesthesia,leaving the resuscitation room,and 1 hour after operation were significantly higher in the 0.7μg group and the 1.0μg group than those in the 0.4μg group,while the SAS score and FLACC score were significantly lower(all P<0.05).Compared with the 0.4μg group,the incidence of emergence agitation[12.0%(6/50)and 8.0%(4/50)vs.30.0%(15/50)]and the total incidence of adverse reactions[22.0%(11/50)and 16.0%(8/50)vs.44.0%(22/50)]in children of the 0.7μg group and the 1.0μg group were significantly lower(all P<0.05).Conclusion Infusion of dexmedetomidine 0.7μg/kg before anesthesia induction in pediatric abdominal sur‑gery under general anesthesia has little effect on the awakening from anesthesia,with good sedation effect and low incidence of adverse reactions,which is the optimal dosage.