Diagnostic Feasibility of 100 Hz Tetanic Stimulation in the Perioperative Setting in Patients with Normal and Abnormal ENG: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 100 Hz tetanic fade response of abductor digiti minimi muscle to ulnar nerve stimulation in patients with normal and abnormal ENG
研究概览
简要总结
The goal of this observational study is to investigate the applicability of 100 Hz tetanic stimulation with an electromyography device in the exclusion of postoperative residual neuromuscular block. The aim is to determine whether fatigue develops with 100 Hz tetanic stimulation in anaesthetized, non-relaxed patients with normal or abnormal baseline electroneurographic (ENG) findings.
详细描述
The aim of the present study is to investigate the applicability of 100 Hz tetanic stimulation with an electromyography (EMG) device. The aim is to determine whether fatigue develops with 100 Hz tetanic stimulation in anaesthetized, non-relaxed patients with normal or abnormal baseline electroneurographic (ENG) findings. Electric responses of the musculus digiti minimi elicited by supramaximal stimulation of the ulnar nerve at the carpal tunnel are monitored. Alpine Biomed ENG-EMG device with Keypoint software version 5.11 is used for the examinations. The exposed arm is fixed on the armboard, the skin is degreased and then the electrodes for monitoring are mounted lege artis. After the anesthesia has been induced, ENG of the ulnar nerve is examined. Based on the results of the ENG test, patients are divided into separate groups (normal or abnormal ENG). During the ENG test, the supramaximal current is determined. Afterwards, repetitive tetanic stimulation of the defined frequency (60 and 100 Hz) and duration (5 sec) is applied to the two test groups at the current according to the test plan.
The clinical utilities of the study results are:
- Determination of the "safety margin" of neuromuscular junction, which is not provided by routine monitoring.
- To investigate how comorbid status (especially chronic conditions affecting peripheral nerves such as polyneuropathy) influences the feasibility of tetanic stimulation in the diagnostics of residual neuromuscular block and safety margin.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 18.5-25 (normal body weight);
- •patient is in supine position with one arm accessible.
排除标准
- •diseases with impaired neuromuscular function (myopathies, severe liver and kidney failure);
- •drugs affecting neuromuscular function (magnesium, aminoglycosides);
- •pregnancy (pregnancy tests are carried out in women of childbearing age to rule out pregnancy);
- •breast-feeding;
- •acute surgery
结局指标
主要结局
100 Hz tetanic fade response of abductor digiti minimi muscle to ulnar nerve stimulation in patients with normal and abnormal ENG
时间窗: From enrollment until end of anesthesia asessed up to 1 hour. No further ENG measurements are performed in the postoperative period.
Electroneurography response of the abductor digiti minimi muscle to 100 Hz tetanic stimulation (tetanic fade) is examined to find out if there is difference in patients with or without polyneuropathy. Tetanic fade is the decrease of the twitch heights of the compound muscle action potential due to depletion of cetylcholin stores in the nerve terminal during tetanic stimulation.
次要结局
- Diagnostic feasibility of electromyography in the examination of safety margin(From enrollment until end of anesthesia assessed up to 1 hour. No further ENG measurements are performed in the postoperative period.)
研究者
Pongrácz Adrienn
assistant professor
University of Debrecen