口服黏膜下右美托咪定用于控制扁桃体切除术后儿童的苏醒期躁动：一项随机对照试验
[Oral trans-mucosal dexmedetomidine for controlling of emergence agitation in children undergoing tonsillectomy: a randomized controlled trial].
作者信息
Abdel-Ghaffar Hala S, Abdel-Wahab Amani H, Roushdy Mohammed M
机构信息
Assiut University, Faculty of Medicine, Anesthesia and Intensive Care Department, Assiut, Egito.
Assiut University, Faculty of Medicine, Anesthesia and Intensive Care Department, Assiut, Egito.
出版信息
Braz J Anesthesiol. 2019 Sep-Oct;69(5):469-476. doi: 10.1016/j.bjan.2019.06.012. Epub 2019 Oct 28.
OBJECTIVES
Emergence agitation is a negative behavior commonly recorded after pediatric tonsillectomy. We investigated the efficacy of preoperative premedication with oral transmucosal buccal dexmedetomidine on the incidence and severity of emergence agitation in preschool children undergoing tonsillectomy under sevoflurane anesthesia.
METHODS
Ninety patients aged (3–6 years), ASA I‒II were enrolled into three groups (n = 30) to receive oral transmucosal dexmedetomidine 0.5 µg.kg (Group DEX I), 1 µg.kg (Group DEX II) or saline placebo (Group C). Our primary endpoint was the Watcha agitation score at emergence in PACU. Secondary outcomes were preoperative sedation score, intraoperative hemodynamics, postoperative Objective Pain Scale (OPS) and adverse effects.
RESULTS
The patients’ demographics, preoperative sedation scores and extubation time showed no difference between groups. Significant differences between groups in incidence and frequency distribution of each grade of Watcha score were evident at 5 minutes ( = 0.007), 10 minutes ( = 0.034), 30 minutes ( = 0.022), 45 minutes ( = 0.034) and 60 minutes ( = 0.026), postoperatively with significant differences between DEX I and II groups. DEX groups showed lower OPS scores at 5 minutes ( = 0.011), 10 minutes ( = 0.037) and 30 minutes ( = 0.044) after arrival at PACU, with no difference between DEX I and II groups. Patients in DEX II group exhibited lower intraoperative mean heart rate at 15 min ( = 0.020), and lower mean arterial pressure at 30 minutes, ( = 0.040), 45 minutes ( = 0.002) and 60 minutes ( = 0.006) with no significant differences between groups in other time points.
CONCLUSION
This study demonstrates the clinical advantage and the simple technique of oral transmucosal DEX premedication for emergence agitation in preschool children undergoing tonsillectomy under sevoflurane anesthesia compared with saline placebo.
TRIAL REGISTRATION
Clinical Trials.gov trial registry: NCT02720705.
目的
苏醒期躁动是小儿扁桃体切除术后常见的不良行为。我们研究了术前口服经黏膜颊部右美托咪定预处理对七氟醚麻醉下行扁桃体切除术的学龄前儿童苏醒期躁动的发生率及严重程度的影响。
方法
90例年龄在3至6岁、美国麻醉医师协会（ASA）分级为I-II级的患儿被分为三组（每组n = 30），分别接受口服经黏膜右美托咪定0.5μg/kg（DEX I组）、1μg/kg（DEX II组）或生理盐水安慰剂（C组）。我们的主要终点是患儿在麻醉后恢复室（PACU）苏醒时的Watcha躁动评分。次要结局指标包括术前镇静评分、术中血流动力学、术后客观疼痛量表（OPS）评分及不良反应。
结果
三组患儿的人口统计学资料、术前镇静评分及拔管时间无差异。术后5分钟（P = 0.007）、10分钟（P = 0.034）、30分钟（P = 0.022）、45分钟（P = 0.034）和60分钟（P = 0.026）时，各组Watcha评分各等级的发生率及频率分布存在显著差异，DEX I组和DEX II组之间差异显著。到达PACU后5分钟（P = 0.011）、10分钟（P = 0.037）和30分钟（P = 0.044）时，DEX组的OPS评分较低，DEX I组和DEX II组之间无差异。DEX II组患儿在术中15分钟时平均心率较低（P = 0.020），在30分钟（P = 0.040）、45分钟（P = 0.002）和60分钟（P = 0.006）时平均动脉压较低，其他时间点各组之间无显著差异。
结论
本研究表明，与生理盐水安慰剂相比，口服经黏膜右美托咪定预处理对于七氟醚麻醉下行扁桃体切除术的学龄前儿童的苏醒期躁动具有临床优势且操作简单。
试验注册
ClinicalTrials.gov试验注册编号：NCT02720705。
Zotero 插件