Comparison of Two Quantitative Electromyography Monitors for Deep Neuro Muscular Block in Patients Undergoing Abdominal Laparoscopic/Robotic or Thoracic Video-Assisted (VATS) Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Incidence of intraoperative diaphragmatic movement during deep neuromuscular blockade
研究概览
简要总结
The main objective of the study is to compare the frequency of intraoperative spontaneous diaphragmatic movements and breath-initiation efforts in participants undergoing robotic and/or thoracic surgery under deep neuromuscular blockade (NMB), using either the TetraGraph or TwitchView applied to the dominant hand. These events will serve as objective indicators to evaluate each device's ability to monitor and maintain adequate deep NMB.
详细描述
This study is a prospective intraoperative device comparison trial evaluating neuromuscular blockade monitoring using two quantitative EMG-based devices, the TetraGraph (Senzime) and TwitchView (Blink), during elective laparoscopic, robotic, or video-assisted thoracoscopic (VATS) abdominal surgeries requiring neuromuscular blockade. Participants will be assigned to receive both monitoring devices simultaneously, placed on opposite upper extremities, allowing each subject to serve as their own control. Standard anesthesia care will be maintained throughout the procedure, including volatile anesthetic titration, opioid administration as needed, mechanical ventilation targeting normocapnia, temperature regulation, and routine neuromuscular blockade management with rocuronium and reversal with sugammadex per institutional practice. Neuromuscular function will be continuously assessed using train-of-four (TOF), train-of-four ratio, and post-tetanic count (PTC) measurements, with data recorded at predefined intraoperative time points including baseline, post-paralytic administration, maintenance, reversal, and prior to extubation. Additional data will include dosing of neuromuscular blocking agents, physiologic parameters, and intraoperative clinical observations relevant to depth of blockade and recovery. Provider usability and workflow integration will be evaluated postoperatively through brief standardized surveys assessing device usability, signal quality, and overall satisfaction. All collected data will be derived from device outputs and routine perioperative clinical documentation without altering standard patient care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Care Provider, Investigator)
盲法说明
Only the designated primary (dominant) monitoring device will be visible to clinicians and used for clinical decision-making regarding neuromuscular blockade management. The secondary device will remain blinded to the clinical team, and its measurements will not be available for guiding NMB management.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult male or female patients aged ≥ 18 years old.
- •Patients undergo elective abdominal laparoscopic/robotic or thoracic video-assisted (VAT) surgeries requiring general anesthesia for greater than 3 hours at The Ohio State University Wexner Medical Center.
- •Able to provide a signed, written informed consent.
- •Able to speak, read, and write in English.
- •ASA physical status I-III.
排除标准
- •Patients who require emergency surgery or an emergent intervention.
- •Any documented cognitive or psychological disorders that, in the investigator's opinion, can interfere with the patient's pain perception.
- •Vulnerable populations: pregnant females, prisoners, breastfeeding.
- •Presence of any medical condition that, in the opinion of the principal investigator, should exclude the patient from the study (patients with pre-existing neuromuscular diseases.
- •Allergy or contraindications to any of the anesthetics, NMB agents, or sugammadex.
- •Patients with anatomical abnormalities of the hands or arms that prevent proper placement of the sensors for nerve stimulation.
- •Limited access to the monitoring area due to surgical positioning.
- •Patients with peripheral vascular disease, since it may affect measurement accuracy.
结局指标
主要结局
Incidence of intraoperative diaphragmatic movement during deep neuromuscular blockade
时间窗: During maintenance of deep neuromuscular blockade throughout the surgical procedure, from achievement of deep neuromuscular blockade after induction of general anesthesia until completion of surgery prior to emergence.
The number of spontaneous diaphragmatic movement events observed during maintenance of deep neuromuscular blockade will be recorded and compared between participants monitored with the TetraGraph (Senzime) and TwitchView (Blink) electromyography (EMG) neuromuscular monitoring devices.
Incidence of spontaneous breath-initiation efforts during deep neuromuscular blockade
时间窗: During maintenance of deep neuromuscular blockade throughout the surgical procedure, from achievement of deep neuromuscular blockade after induction of general anesthesia until completion of surgery prior to emergence.
The number of spontaneous breath-initiation efforts observed during maintenance of deep neuromuscular blockade will be recorded and compared between participants monitored with the TetraGraph (Senzime) and TwitchView (Blink) EMG neuromuscular monitoring devices.
次要结局
- Intubation Difficulty Scale (IDS) score(During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.)
- Incidence of patient movement or bucking during intubation(During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.)
- Cormack-Lehane grade of vocal cord visibility during intubation(During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.)
- Vocal cord movement during intubation(During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.)
- Post-tetanic count (PTC)(Throughout the intraoperative period during maintenance of neuromuscular blockade, from induction of general anesthesia until initiation of emergence from anesthesia.)
- Train-of-four (TOF) count(Throughout the intraoperative period during maintenance of neuromuscular blockade, from induction of general anesthesia until initiation of emergence from anesthesia.)
- Time to recovery of train-of-four ratio >0.9(During emergence from anesthesia, from administration of neuromuscular blockade reversal agent until extubation.)
- Train-of-four ratio before extubation(Immediately before extubation following completion of surgery and recovery from neuromuscular blockade.)
- System Usability Scale (SUS) score(Immediately after completion of the intraoperative procedure and device use.)
- Leiden Surgical Rating Scale (L-SRS) score(At completion of the surgical procedure, prior to emergence from general anesthesia.)
研究者
Boris Mraovic
Professor of Clinical Anesthesiology
Ohio State University