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临床试验/NCT02498678
NCT02498678已完成不适用

Effect of Tetanus on Neuromuscular Junction Monitor Performance in Pediatric Patients Undergoing Abdominal and / or Perineal Surgical Procedures With Using of Rocuronium

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Train of Four 0,9 (90%)

研究概览

简要总结

The objective of this study is to assess the performance of acceleromyography as a method of evaluation of muscle relaxation after application of tetanus stimulation to obtain stability of responses before administration of neuromuscular blocking agents.

详细描述

Effect of tetanus on neuromuscular junction monitor performance in pediatric patients undergoing abdominal and / or perineal surgical procedures with the use of rocuronium.

Routine monitoring of neuromuscular function during anesthesia offers some advantages. It helps promote proper relaxation according to each patient's individual sensitivity and reduces the possibility of postoperative residual block with its serious consequences, namely: reducing pulmonary forced vital capacity, decreased ability to increase ventilation during periods of hypoxia, increased risk of pulmonary aspiration due to lower strength of pharyngeal muscles. It can also reduce the waste of time caused by excessive paralysis. Furthermore, the interpretation of data from the monitor may indicate that pharmacological reversal of neuromuscular blockade is not required, with potential benefits over costs, as well as lower incidence of postoperative nausea and vomiting.

Acceleromyography was introduced for use in daily clinical practice in 1988 as a simple, reliable and easy to apply in the anesthetized patient monitor to assess muscle relaxation. The purpose of this neuromuscular junction (NMJ) monitor was replace mechanomyography, this modality that has greater complexity of assembling and using. The mechanomyography was considered long, the ideal objective neuromuscular monitoring. This measures the strength of isometric contraction of a muscle or digit (e.g. thumb) in response to nerve stimulation. Moreover, it requires an assembly that demands time and with strict rules for the positioning and application of non elastic preload on the thumb. This makes the method impractical for everyday use. Furthermore, monitors based on the method of mechanomyography are no longer commercially available. Acceleromyography gradually replaced mechanomyography as a method to monitor muscle relaxation in clinical practice and research.

Acceleromyography measures the acceleration (isotonic contraction) of a muscle or finger. The method is based on Newton's second law, which states that force is equal to the product of mass and acceleration. If the mass (e.g. thumb) is constant, the acceleration is directly proportional to the force. This means, in principle, it measures the unrestricted movement of the muscle in question.

Monitoring must present a stable response (baseline) for a period of 2 to 5 minutes before administration of neuromuscular blocker. The time required to reach this stable response depends on the duration of electrical stimulation and frequency in which electrical stimulation are applied. When using single mode stimulus at a frequency of 0.1 Hertz (Hz) or train-of-four (TOF) every 12 to 15 seconds, it may take 5 to 20 minutes to obtain a stable response. However, the stabilization period may be shortened by applying a short, high frequency stimulation (tetanic stimulation). Tetanic stimulation for 5 seconds can decrease the stabilization period of 2 to 5 minutes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
2 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Physical Status 1-2, aged 2 to 11 years, regardless of genders) who will undergo abdominal and / or perineal surgery, with planned surgical time greater than 60 minutes

排除标准

  • Patients with diseases or medications that are known to interfere with neuromuscular transmission, hepatic or renal dysfunction or allergy to medications used in the study will be excluded

结局指标

主要结局

Train of Four 0,9 (90%)

时间窗: An expected average of 60 minutes

Time to recovery to train of four 0,9 (90%). When the fourth stimulus value (T4) divided by the first stimulus (T1) reaches the ratio of 0.9 (T4 / T1)

T1 Height

时间窗: An expected average of 60 minutes

T1 height documentation when train of four reaches 0,9 (90%)

次要结局

  • Time to Obtain T1 Height Stability(An expected average of 60 minutes)
  • Monitor Settings - Electric Current(An expected average of 60 minutes)
  • Monitor Settings - Sensitivity(An expected average of 60 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ricardo Vieira Carlos

Staff Physician

University of Sao Paulo General Hospital

研究点 (2)

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