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临床试验/NCT05474638
NCT05474638已完成不适用

Comparison of Mechanomyographic 100 Versus 200 Hz 5 Second Tetanic Fade Ratios During Neuromuscular Block Recovery

Centre Hospitalier Universitaire UCLouvain Namur2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年10月25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
20
试验地点
2
主要终点
100 vs 200 Hz Tetanic Fade Ratio comparison

研究概览

简要总结

Two recent pilot studies suggested the potential interest of 100 and 200 Hz tetanic stimulations to detect with mechanomyography (MMG) very low levels of residual neuromuscular blockade (NMB). The Tetanic Fade Ratio (TFR, residual force after 5 seconds / maximal force) measured quantitatively by MMG during tetanic stimulation at 100 or 200 Hz could provide today a more consistent response than the train-of-four (TOF) ratio provided by acceleromyography (AMG) to this search for detection of low levels of residual NMB.

This study was designed to evaluate for the first time in anesthetized patients the evolution of NMB spontaneous recovery with 5-second 100 and 200 Hz tetanic stimulations compared to TOF, and to test the hypothesis that a 200 Hz TFR would better and longer detect low levels of residual paralysis than AMG TOF ratio and 100 Hz TFR.

详细描述

MATERIALS AND METHODS Patient management The monocentric study protocol was approved before patients' inclusion by the Institutional Ethical Committee (CHU UCL Namur, Yvoir, Belgium, OM 050, under unique belgian registration number B0392022000035).

It was performed in accordance with the ethical standards of the Declaration of Helsinki and was included in the Clinical Trials Registry (XXX).

After obtaining written informed consent from all participants, 20 patients with American Society of Anesthesiologists (ASA) grades I to II (aged 18 to 65 years), who were scheduled to undergo rhinoplasty or rhinoseptoplasty under general anaesthesia, were included in the study. The exclusion criteria were pregnant or breastfeeding women, patients with renal or hepatic insufficiency, patients with neurological disorders, and any patient with a suspected allergy to the drugs used in the protocol or receiving medications that could interfere with neuromuscular transmission. The patient's height, weight, age, and sex were recorded in the protocol to define the population investigated.

The patients were conventionally monitored with a pulse oximeter, a three-lead electrocardiogram and a non-invasive blood pressure monitor scheduled in automatic mode at 5-minute intervals. An intravenous catheter was inserted into their forearm for crystalloid infusion (side at random). Neuromuscular transmission monitoring (NMTM) was set up according to a specific protocol.

Total intravenous anaesthesia was induced with continuous infusion of remifentanil 0.25 µg/kg/min and continuous infusion of propofol 1% to obtain theoretical plasma concentrations ranging from 3 to 6 µg/mL (Diprifusor Cardinal Health, Basingstoke, UK). Lidocaine 1 mg/kg was also given as an intravenous bolus. After loss of consciousness, manual ventilation was provided during NMTM calibration and the initial NMB baseline measurements. Then, rocuronium 0.45 mg/kg was administered. Non-invasive automatic blood pressure measurement was suspended during the neuromuscular onset to avoid dissimilar distribution of the rocuronium in the two arms. Tracheal intubation was performed when the TOF count reached zero. Automatic non-invasive blood pressure measurement was reactivated. Mechanical ventilation (closed circuit, 40% oxygen in air) maintained end-tidal CO2 within the normal range. Anesthesia was maintained with the continuous intravenous administration of remifentanil 0.15 µg/kg/min and propofol with a target plasma concentration of 2 to 4 µg/mL. Blankets prevented heat loss from the body and both arms, and the oropharyngeal temperature was kept stable. Postoperative analgesia was provided with paracetamol, tramadol and alizapride at the end of surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • written informed consent
  • general anesthesia for rhino(septo)plasty

排除标准

  • pregnant or breastfeeding women
  • patients with renal or hepatic insufficiency
  • patients with neurological disorders
  • patients with a suspected allergy to the drugs used in the protocol
  • patients receiving medications that could interfere with neuromuscular transmission

结局指标

主要结局

100 vs 200 Hz Tetanic Fade Ratio comparison

时间窗: During surgery while the neuromuscular block spontaneously recovers from AMG TOF count 1 until TOF ratio 1.0

To compare 100 and 200 Hz TFR at different literature based spontaneous recovery levels recorded by acceleromyography on the other arm: TOF count 1, TOF ratio 0.5 and TOF ratio 0.9 / normalized 0.9 / 0.95 / 1.0.

次要结局

  • Quantification of any remaining MMG fade with 200 Hz stimulation after AMG TOF ratio 0.9 recovery(During surgery while the neuromuscular block spontaneously recovers from AMG TOF ratio 0.9 until MMG 200 Hz TFR > 0.9)

研究者

发起方
Centre Hospitalier Universitaire UCLouvain Namur
申办方类型
Other
责任方
Principal Investigator
主要研究者

Philippe Dubois

Professor Philippe Dubois

Centre Hospitalier Universitaire UCLouvain Namur

研究点 (2)

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