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低剂量艾司氯胺酮联合丙泊酚用于小儿显微斜视手术:一项随机对照研究

Low-dose Esketamine combined with Propofol in microscopic pediatric strabismus surgery: a randomized controlled study.

作者信息

Shen Yaping, Shi Bo, Mo Yu, Wu Junhe, Sun Zhentao

机构信息

Department of Anesthesiology, Perioperative and Pain Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450000, China.

出版信息

BMC Anesthesiol. 2025 May 14;25(1):241. doi: 10.1186/s12871-025-03095-x.

Abstract

OBJECTIVE

To observe the effect of low-dose esketamine combined with propofol in pediatric strabismus surgery.

METHODS

A total of 84 children aged 3-15 years, regardless of gender, with a BMI of 13-26 kg/m, ASA grade I or II, were selected for elective microscopic strabismus surgery and divided into two groups based on the randomized numerical table: esketamine group (group E) and propofol group (group C), with 42 patients in each group. Group E was pre-injected with esketamine 0.2 mg/kg, and propofol 2.5 mg/kg was slowly injected after one minute. Group C was pre-treated with an equal volume of saline, and propofol 2.5 mg/kg was administered slowly after one minute. The occurrence of propofol injection pain was assessed using the Verbal Rating Scale (VRS). HR and MAP were recorded in the two groups at 5 min before induction, after induction, at the start of the procedure, and at the end of the procedure. operative time, extubation time and post-anesthesia care unit (PACU) stay were recorded. The Pain Behaviour Scale for Children (Face, Legs, Activity, Cry, Consolability, FLACC) scores at the time of discharge from the PACU and at 1day, 3days and 7days postoperatively were recorded. perioperative tachycardia, emergence agitation, oculocardiac reflex, extubation cough and other adverse reactions were also recorded.

RESULTS

Compared with Group C, Group E exhibited significantly lower rates of propofol injection pain(cases (%), 87.5% VS 56.1%, P = 0.002), and moderate-to-severe pain during induction(75.0% VS 24.4%, P<0.001), reduced FLACC scores at PACU discharge(median and interquartile spacing [M(IQR)], 3.50(4) VS 3.00(2), P = 0.039) and 1 day postoperatively(M(IQR), 5.00(3) VS 3.00(2), P<0.001), and decreased incidences of adverse events including emergence agitation(32.5% VS 12.2%, P = 0.028), oculocardiac reflex(35.0% VS 14.6%, P = 0.034), and extubation cough(25.0% VS 7.3%, P = 0.030). However, no statistically significant differences were observed between the two groups in operative duration, extubation time, PACU stay duration, FLACC scores at 3 and 7 days postoperatively, or heart rate and mean arterial pressure at any measured time point.

CONCLUSION

General anesthesia with low-dose esketamine combined with propofol for pediatric strabismus correction surgery effectively alleviates propofol injection pain, reduces FLACC scores at PACU discharge and 1 day postoperatively, and decreases the incidence of adverse reactions such as emergence agitation, oculocardiac reflex, and extubation cough, demonstrating its safety for use in this procedure.

TRIAL REGISTRATION

This study was approved by the Scientific Research and Clinical Trials Ethics Committee of The First Affiliated Hospital of Zhengzhou University (Approval No. 2023-KY-1509), registered in the Chinese Clinical Trial Registry (Registration No. ChiCTR2400092266, registration date on 11/13/2024).

摘要

目的

观察小剂量艾司氯胺酮联合丙泊酚在小儿斜视手术中的效果。

方法

选取84例年龄3 - 15岁、性别不限、BMI为13 - 26kg/m²、ASA分级为Ⅰ或Ⅱ级的儿童,拟行择期显微斜视手术,根据随机数字表分为两组:艾司氯胺酮组(E组)和丙泊酚组(C组),每组42例。E组预先注射艾司氯胺酮0.2mg/kg,1分钟后缓慢注射丙泊酚2.5mg/kg。C组预先给予等量生理盐水,1分钟后缓慢注射丙泊酚2.5mg/kg。采用视觉模拟评分法(VRS)评估丙泊酚注射痛的发生情况。记录两组诱导前5分钟、诱导后、手术开始时及手术结束时的心率(HR)和平均动脉压(MAP)。记录手术时间、拔管时间及麻醉后恢复室(PACU)停留时间。记录PACU出院时及术后1天、3天和7天的儿童疼痛行为量表(面部、腿部、活动、哭闹、安慰度,FLACC)评分。记录围手术期心动过速、苏醒期躁动、眼心反射、拔管咳嗽等不良反应。

结果

与C组相比,E组丙泊酚注射痛发生率显著降低(例数(%),87.5%对56.1%,P = 0.002),诱导期中度至重度疼痛发生率降低(75.0%对24.4%,P<0.001),PACU出院时(中位数和四分位间距[M(IQR)],3.50(4)对3.00(2),P = 0.039)和术后1天(M(IQR),5.00(3)对3.00(2),P<0.001)的FLACC评分降低,苏醒期躁动(32.5%对12.2%,P = 0.028)、眼心反射(35.0%对14.6%,P = 0.034)和拔管咳嗽(25.0%对7.3%,P = 0.030)等不良事件发生率降低。然而,两组在手术时长、拔管时间、PACU停留时长、术后3天和7天的FLACC评分或任何测量时间点的心率和平均动脉压方面均未观察到统计学显著差异。

结论

小剂量艾司氯胺酮联合丙泊酚用于小儿斜视矫正手术的全身麻醉,可有效减轻丙泊酚注射痛,降低PACU出院时及术后1天的FLACC评分,减少苏醒期躁动、眼心反射和拔管咳嗽等不良反应的发生率,表明其用于该手术具有安全性。

试验注册

本研究经郑州大学第一附属医院科研与临床试验伦理委员会批准(批准号:2023 - KY - 1509),在中国临床试验注册中心注册(注册号:ChiCTR2400092266,注册日期:2024年11月13日)。

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