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临床试验/NCT04762420
NCT04762420已完成不适用

Sugammadex Dosing: Anaesthesiologist Clinical Perception Versus Quantitative Monitoring

Hospital do Divino Espírito Santo de Ponta Delgada1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
1
主要终点
The percentage of patients who would receive an adequate or inadequate (over or under) dose of sugammadex.

研究概览

简要总结

Many clinicians continue to rely on subjective evaluation in making decisions about the adequacy of neuromuscular function before tracheal extubation rather than using quantitative monitoring. The aim was to compare the sugammadex dose as suggested by senior anaesthesiologists (SSD) based on clinical experience versus the dose determined by quantitative monitoring (QSD) to determine if the subjective dose was appropriate.

详细描述

Materials and Methods

After obtaining approval from the Institute Ethics Committee, a prospective 3-month study in patients aged 18-75 years who underwent general anesthesia with rocuronium (initial dose 0.6 mg/kg) NMB and subsequent reversal with sugammadex, was carried out. American Society of Anesthesiologists (ASA ) physical status V, emergency surgery, patients with hypersensitivity history to rocuronium or sugammadex, severe renal impairment/dialysis, neuromuscular diseases, severe hepatic disease, pre-existing coagulopathies and pregnancy were excluded. Monitoring included ASA standard monitoring, bispectral index and NMB monitoring using TOFscan® monitor. The senior anaesthesiologist was blinded to the TOFscan®, which was only available to the author.

At the time of pharmacologic reversal of NMB, both the sugammadex dose proposed by the anaesthesiologist (SSD) and the dose suggested by TOFscan® (QSD) according to the Portuguese recommendations for the management of NMB were recorded. Afterwards the QSD was administered to overcome ethical issues. When train-of-four (TOF) count was 0, the author performed the post tetanic count (PTC) stimulus to determine the recommended dose. The SSD was considered appropriate if it was within 10% of the QSD for the depth of NMB. All patients were extubated with a TOF ratio > 0.9 (TOFr) and both the rocuronium and sugammadex dose were calculated based on the real patient weight. Data regarding anaesthesia, duration of anaesthesia and dosing pattern of rocuronium were also noted. The results were analysed descriptively.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-75 years;
  • Above patients who underwent general anesthesia with rocuronium neuromuscular blockade and subsequent reversal with sugammadex.

排除标准

  • American Society of Anesthesiologists physical status V;
  • Emergency surgery;
  • Hypersensitivity history to rocuronium or sugammadex;
  • Severe renal impairment/dialysis;
  • Neuromuscular diseases;
  • Severe hepatic disease;
  • Pre-existing coagulopathies;
  • Pregnancy.

结局指标

主要结局

The percentage of patients who would receive an adequate or inadequate (over or under) dose of sugammadex.

时间窗: 3 months

Given the interindividual variability response to neuromuscular block, which makes it difficult to subjectively determine the dose needed, the aim was to compare the sugammadex dose as suggested by senior anaesthesiologists based on clinical experience versus the dose determined by quantitative monitoring to determine if the subjective dose was appropriate.

次要结局

未报告次要终点

研究者

发起方
Hospital do Divino Espírito Santo de Ponta Delgada
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ernesto Ruivo

Principal Investigator

Hospital do Divino Espírito Santo de Ponta Delgada

研究点 (1)

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