Gentle Skin Abrasion and EMG-Based Neuromuscular Blockade Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- EMG Response Amplitude Before Neuromuscular Blocking Drug Administration
研究概览
简要总结
This study will evaluate whether gentle skin abrasion improves electromyographic signal quality during neuromuscular blockade monitoring in adult surgical patients.
Participants will receive standard TwitchView electromyographic neuromuscular blockade monitoring on one wrist and TwitchView monitoring after gentle skin abrasion on the opposite wrist. The study will compare electromyographic response amplitudes and supramaximal stimulus currents between routine electrode application and electrode application after skin preparation.
The study procedures will occur during scheduled surgery and will not alter the anesthetic or surgical management of participants.
详细描述
Neuromuscular blocking agents are commonly used during adult surgical procedures. Quantitative neuromuscular blockade monitoring is used to assess the effects of these drugs and to guide clinical management of neuromuscular blockade and recovery. The TwitchView electromyographic monitor is routinely used for this purpose and uses surface electrodes placed over the ulnar nerve and hand muscles to generate train-of-four measurements.
In some patients, the electromyographic signal obtained with routine electrode application may be poor or inadequate for continuous monitoring. This may be related to skin condition, such as callouses, oily skin, or other factors that affect signal quality. Gentle skin abrasion is a technique commonly used in electrophysiology settings to improve the quality of physiologic electrical signals.
This study will compare electromyographic signals obtained from routinely applied TwitchView electrodes with signals obtained from TwitchView electrodes placed after gentle skin abrasion using 3M Red Dot Trace Prep abrasive strips. After consent is obtained and the participant is moved into the operating room, TwitchView electrodes will be applied to both wrists. One wrist will receive routine electrode application without skin preparation, while the opposite wrist will undergo gentle skin abrasion before standard TwitchView electrodes are applied. Two TwitchView monitors will be used, one for each electrode strip.
After induction of anesthesia, both TwitchView devices will be started. Other than a brief device start-up period, anesthetic and surgical management, including neuromuscular blocking drug dosing and timing, will be determined by the clinical care team and not by the investigators. The devices will record neuromuscular monitoring data during the procedure.
The primary outcome is the amplitude of recorded electromyographic responses to train-of-four stimulation after induction of anesthesia but before administration of a paralytic drug. Secondary outcomes include the supramaximal stimulus current determined by the device and electromyographic signal amplitudes after administration of neuromuscular blocking drugs.
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
盲法说明
This is an open-label study. Study staff and clinical providers are aware of which electrode site receives routine application and which site receives gentle skin abrasion.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult surgical patient aged 18 years or older
- •Classified as American Society of Anesthesiologists Physical Status I, II, or III
- •Scheduled to undergo an elective procedure in which use of a neuromuscular blocking drug is anticipated
- •Neuromuscular blockade monitoring would be standard care for the planned procedure
- •Procedure allows access to both wrists
- •Capable of signing informed consent
排除标准
- •Emergency procedure
- •Procedure in which neuromuscular blocking drugs are not anticipated
- •Access to at least one wrist and ankle is not possible
- •Unable to provide informed consent
- •Prior stroke
- •Hemiparesis or hemiplegia
- •Any other known neuromuscular disorder
- •Employee or student of the researcher
- •Pregnant women, fetuses, neonates, prisoners, children, or adults unable to consent
研究组 & 干预措施
Gentle Skin Abrasion and Standard Electrode Application
Participants will receive standard TwitchView EMG-based neuromuscular blockade monitoring with routine electrode application on one wrist and EMG-based monitoring after gentle skin abrasion on the opposite wrist. EMG signal amplitudes and supramaximal stimulus currents will be compared between the routine and skin-prepped electrode sites within each participant.
干预措施: Gentle Skin Abrasion Before EMG-Based Neuromuscular Blockade Monitoring (Procedure)
结局指标
主要结局
EMG Response Amplitude Before Neuromuscular Blocking Drug Administration
时间窗: During surgery, before paralytic drug administration
Amplitude of recorded EMG responses to train-of-four stimulation will be compared between routine electrode application and electrodes placed after gentle skin abrasion.
次要结局
- Supramaximal Stimulus Current(During device startup after anesthesia induction)
- EMG Response Amplitude After Neuromuscular Blocking Drug Administration(During surgery, after paralytic drug administration)