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罗库溴铵诱导的神经肌肉阻滞用 sugammadex 逆转与依托咪酯麻醉期间新斯的明的比较:一项随机对照试验的结果。

Reversal of rocuronium-induced neuromuscular blockade with sugammadex compared with neostigmine during sevoflurane anaesthesia: results of a randomised, controlled trial.

机构信息

Klinik für Anästhesiologie der Technischen Universität München, Munich, Germany.

出版信息

Eur J Anaesthesiol. 2010 Oct;27(10):874-81. doi: 10.1097/EJA.0b013e32833d56b7.

Abstract

BACKGROUND AND OBJECTIVE

Sugammadex, a modified gamma-cyclodextrin, is a selective relaxant-binding agent designed to reverse the effects of the steroidal neuromuscular blocking agents rocuronium or vecuronium. This study compared the efficacy of sugammadex and neostigmine for reversal of neuromuscular blockade induced by rocuronium for facilitating elective surgery.

METHODS

This randomised, multicentre, parallel-group trial included 98 adult patients. Patients received intravenous propofol for induction followed by sevoflurane maintenance anaesthesia. Neuromuscular blockade was monitored using acceleromyography and a train-of-four (TOF) mode of stimulation. Patients were randomly allocated to receive sugammadex 2.0 mg kg(-1) or neostigmine 50 microg kg (-1) (with glycopyrrolate 10 microg kg(-1)) at reappearance of the second response of the TOF (mean 16% twitch height of first response) after the last dose of rocuronium. Safety was evaluated by assessing adverse events, laboratory variables and vital signs.

RESULTS

Time to recovery of the TOF ratio of 0.9 after sugammadex compared with neostigmine was significantly shorter (P < 0.0001), being 1.5 versus 18.6 min (geometric means). Predictability of response was greater with sugammadex than neostigmine: with 98% of sugammadex patients versus 11% of neostigmine patients recovering to a TOF ratio of 0.9 within 5 min. There were no clinical events related to residual neuromuscular blockade or reoccurrence of blockade. Serious adverse events were observed in two sugammadex-treated patients and in three neostigmine-treated patients, respectively, but none were considered related to study drugs.

CONCLUSION

Sugammadex achieved significantly faster recovery of neuromuscular function after rocuronium to a TOF ratio of 0.9 compared with neostigmine (Clinicaltrials.gov identifier: NCT00451217).

摘要

背景与目的

琥胆酸衍生物(Sugammadex)是一种选择性的松弛剂结合剂,旨在逆转罗库溴铵或维库溴铵等甾体类神经肌肉阻滞剂的作用。本研究比较了琥珀酸衍生物和新斯的明在反转罗库溴铵引起的神经肌肉阻滞以促进择期手术中的效果。

方法

这是一项随机、多中心、平行组试验,纳入了 98 名成年患者。患者接受异丙酚静脉诱导,随后接受七氟醚维持麻醉。使用加速度肌电图和四串(TOF)刺激模式监测神经肌肉阻滞。患者在罗库溴铵最后一次给药后,当 TOF 的第二个反应(第一个反应的 16%肌颤搐高度)再次出现时,随机分配接受琥珀酸衍生物 2.0mg/kg 或新斯的明 50μg/kg(同时给予 10μg/kg 的格隆溴铵)。通过评估不良事件、实验室变量和生命体征来评估安全性。

结果

与新斯的明相比,琥胆酸衍生物恢复 TOF 比值至 0.9 的时间明显更短(P < 0.0001),分别为 1.5 分钟和 18.6 分钟(几何均数)。琥胆酸衍生物的反应预测性优于新斯的明:琥胆酸衍生物组有 98%的患者,新斯的明组有 11%的患者在 5 分钟内恢复至 TOF 比值为 0.9。没有与残留神经肌肉阻滞或阻滞再发相关的临床事件。琥胆酸衍生物组有 2 例患者和新斯的明组有 3 例患者发生严重不良事件,但均认为与研究药物无关。

结论

与新斯的明相比,琥胆酸衍生物能更显著地加快罗库溴铵至 TOF 比值为 0.9 时的神经肌肉功能恢复(Clinicaltrials.gov 标识符:NCT00451217)。

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