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右美托咪定与丙泊酚联合用于小儿深度镇静的协同作用:一项随机试验。

The synergistic effect of dexmedetomidine on propofol for paediatric deep sedation: A randomised trial.

机构信息

From the Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Harvard Medical School, Boston (KPM, RSP, CAS), Special Care Nursery, Winchester Hospital,Winchester (EMH), Department of Experimental Therapeutics/Interventional Trials, Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston (STI), Boston Biostatistical Consulting, North Reading (DC), Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital (KL, RP) and Division of Gastroenterology, Hepatology & Nutrition, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA (VLF).

出版信息

Eur J Anaesthesiol. 2021 May 1;38(5):541-547. doi: 10.1097/EJA.0000000000001350.

Abstract

BACKGROUND

Propofol and dexmedetomidine are used separately, and sometimes together, for paediatric deep sedation. Although their combination has been described in adults, the effect of dexmedetomidine as a potential synergist in children has not been studied before.

OBJECTIVES

The primary objective was to compare the propofol requirements of children who receive propofol alone with those who receive it in combination with dexmedetomidine for deep sedation for upper and lower endoscopic gastrointestinal procedures.

DESIGN

This was a prospective, open-label, randomised study comparing patients who received propofol alone (group P) with those who received dexmedetomidine and propofol (group DP). The depth of sedation was titrated to a target bispectral (BIS) index.

SETTING

A Gastroenterology Procedure Unit at a single, tertiary care academic medical centre from April 2018 until December 2019.

PATIENTS

Eligible patients were scheduled for upper endoscopy, lower endoscopy or both. A total of 39 patients were enrolled (20 DP) and (19 P).

INTERVENTIONS

Patients in Group DP received dexmedetomidine 0.5 μg kg-1 administered over 1 min followed by an infusion of 0.15 μg kg-1 h-1. In both groups, intravenous propofol was given in bolus increments titrated to a BIS index of 40 to 50 and then a continuous infusion of propofol to maintain BIS at 40 to 50.

MAIN OUTCOME MEASURES

The primary outcome measure was propofol requirement in each group. Secondary outcome measures were time to achieve the targeted sedation depth, time to achieve an Aldrete recovery score of 9, duration of sedation, mean BIS values, adverse events, 'PAED' scores and time to discharge from the postanaesthesia care unit (PACU).

RESULTS

The median (range) total dose of propofol was 0.23 (0.10 to 0.50) mg kg-1 min-1 in group DP and 0.40 (0.20 to 0.50) mg kg-1 min-1 in group P (P = 0.0004). Time of discharge from the PACU was 60 (20 to 121) min in group DP and 63 (46 to 91) min in group P (P = 0.0409).

CONCLUSION

The combination of dexmedetomidine and propofol for paediatric procedural sedation achieved a significant reduction in median propofol dose and a slightly shorter median time to discharge from PACU. Large-scale studies may determine whether this reduction decreases the risk of significant adverse events.

TRIAL REGISTRATION

ClinicalTrials.gov identifier NCT02952222.

摘要

背景

丙泊酚和右美托咪定分别用于小儿深度镇静,有时也联合使用。虽然它们在成人中的联合应用已有描述,但右美托咪定作为小儿潜在协同剂的作用尚未得到研究。

目的

本研究的主要目的是比较单独使用丙泊酚和联合使用右美托咪定进行上、下内窥镜胃肠检查时小儿所需的丙泊酚剂量。

设计

这是一项前瞻性、开放标签、随机研究,比较了单独使用丙泊酚的患者(P 组)和接受丙泊酚联合右美托咪定的患者(DP 组)。镇静深度被滴定至双频谱指数(BIS)目标值。

地点

2018 年 4 月至 2019 年 12 月,在一家单中心、三级学术医疗中心的胃肠病学诊疗室。

患者

纳入接受上内窥镜检查、下内窥镜检查或两者兼有的患者。共有 39 名患者入组(DP 组 20 例,P 组 19 例)。

干预措施

DP 组患者给予右美托咪定 0.5μg/kg,静脉推注 1 分钟,然后以 0.15μg/kg/h 的速度输注。在两组中,均给予异丙酚静脉推注,剂量递增至 BIS 指数 40-50,然后给予异丙酚持续输注,维持 BIS 指数 40-50。

主要观察指标

主要观察指标为每组丙泊酚的用量。次要观察指标为达到目标镇静深度的时间、达到 Aldrete 恢复评分 9 分的时间、镇静时间、平均 BIS 值、不良事件、“PAED”评分和从麻醉后监护室(PACU)出院的时间。

结果

DP 组丙泊酚总剂量中位数(范围)为 0.23(0.10-0.50)mg/kg/min,P 组为 0.40(0.20-0.50)mg/kg/min(P=0.0004)。DP 组 PACU 出院时间中位数为 60(20-121)分钟,P 组为 63(46-91)分钟(P=0.0409)。

结论

丙泊酚联合右美托咪定用于小儿程序镇静可显著降低丙泊酚剂量中位数,并略微缩短 PACU 出院时间中位数。大规模研究可能会确定这种减少是否会降低严重不良事件的风险。

试验注册

ClinicalTrials.gov 标识符 NCT02952222。

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