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神经肌肉阻滞对新生儿和小婴儿腹腔镜手术中手术条件的影响:一项随机对照试验。

Effect of neuromuscular block on surgical conditions during laparoscopic surgery in neonates and small infants: A randomised controlled trial.

机构信息

From the Department of Anaesthesiology, Hunan Children's Hospital, Changsha, China.

出版信息

Eur J Anaesthesiol. 2023 Dec 1;40(12):928-935. doi: 10.1097/EJA.0000000000001898. Epub 2023 Aug 23.

Abstract

BACKGROUND

Neuromuscular block (NMB) is routinely used in paediatric and adult anaesthesia to facilitate endotracheal intubation and optimise surgical conditions. However, there are limited data regarding NMB and optimising the conditions for laparoscopic surgery in neonates and small infants.

OBJECTIVE

The goal of this study was to determine the effect of NMB on the conditions for laparoscopic surgery in neonates and small infants.

DESIGN

A randomised controlled trial.

SETTING

Single-centre Children's Hospital, conducted from November 2021 to December 2022.

PATIENTS

One hundred and two ASA I-II neonates and small infants aged up to 60 weeks postmenstrual age who were scheduled to undergo an elective laparoscopic Ladd's procedure were included in the study.

INTERVENTIONS

Patients were randomised into three groups: no NMB group, shallow NMB group and moderate NMB group. Each group was given different doses of rocuronium to achieve the target depth of NMB.

MAIN OUTCOME MEASURES

The primary outcome was the quality of the surgical conditions evaluated with the Leiden-Surgical Rating Scale (L-SRS) by a blinded surgeon. Secondary outcomes included tracheal intubating conditions and adverse events.

RESULTS

The percentage of L-SRS scores of 4 or 5 was similar among the three groups at all the assessment times ( P  > 0.05 for each time interval). The distribution of L-SRS scores was also similar among the three groups. There were no significant differences in operating condition scores between the groups at any time interval ( P  > 0.05 for each time interval). The incidence of adverse events during anaesthesia induction was significantly higher in the no NMB group (51.4%) than in the other two groups (13.6% and 14.7%) (adjusted P  = 0.012 and adjusted P  = 0.003). In particular, clinically unacceptable intubation conditions occurred in 12 patients (34.3%) in the no NMB group, significantly more than in the shallow NMB group (6.1%, adjusted P  = 0.012) and moderate NMB group (2.9%, adjusted P  = 0.003). There was no statistically significant difference in the incidence of adverse events in the PACU among the three groups ( P  = 0.103).

CONCLUSIONS

The depth of NMB was not associated with superior surgical conditions during laparoscopic surgery, but it was associated with a reduction in adverse events during induction and maintenance of anaesthesia in neonates and small infants.

TRIAL REGISTRATION

Registered at www.chictr.org.cn (ChiCTR2100052296).

摘要

背景

神经肌肉阻滞(NMB)在小儿和成人麻醉中常规用于辅助气管插管和优化手术条件。然而,关于 NMB 以及优化新生儿和小婴儿腹腔镜手术条件的数据有限。

目的

本研究旨在确定 NMB 对新生儿和小婴儿腹腔镜手术条件的影响。

设计

随机对照试验。

设置

单中心儿童医院,于 2021 年 11 月至 2022 年 12 月进行。

患者

102 例 ASA I-II 级新生儿和小婴儿,胎龄为 60 周以内,拟行择期腹腔镜 Ladd 手术。

干预措施

患者随机分为三组:无 NMB 组、浅 NMB 组和中 NMB 组。每组给予不同剂量的罗库溴铵以达到 NMB 的目标深度。

主要观察指标

主要观察指标为盲法外科医生使用 Leiden-Surgical Rating Scale(L-SRS)评估的手术条件质量。次要观察指标包括气管插管条件和不良事件。

结果

在所有评估时间点,三组之间的 L-SRS 评分 4 或 5 的比例相似(各时间间隔 P >0.05)。三组之间的 L-SRS 评分分布也相似。各时间间隔组间手术条件评分无显著差异(各时间间隔 P >0.05)。无 NMB 组(51.4%)麻醉诱导期间不良事件的发生率明显高于其他两组(13.6%和 14.7%)(调整后 P =0.012 和调整后 P =0.003)。特别是在无 NMB 组中,12 例患者(34.3%)出现临床不可接受的插管条件,明显多于浅 NMB 组(6.1%,调整后 P =0.012)和中 NMB 组(2.9%,调整后 P =0.003)。三组患者 PACU 不良事件发生率无统计学差异(P =0.103)。

结论

NMB 的深度与腹腔镜手术期间的手术条件无相关性,但与减少新生儿和小婴儿麻醉诱导和维持期间的不良事件相关。

试验注册

在中国临床试验注册中心注册(ChiCTR2100052296)。

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