Comparison of Two Quantitative EMG Monitors for Deep Neuromuscular Block in Laparoscopic/Robotic and VATS Surgery

Официальное название

Comparison of Two Quantitative Electromyography Monitors for Deep Neuro Muscular Block in Patients Undergoing Abdominal Laparoscopic/Robotic or Thoracic Video-Assisted (VATS) Surgeries

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство TetraGraph (Senzime)-Guided Neuromuscular Monitoring (Dominant Hand)
  The TetraGraph (Senzime) quantitative electromyography (EMG) neuromuscular monitoring device will be applied to the participant's dominant hand after induction of general anesthesia and prior to neuromuscular blocking agent administration. Surface electrodes will be placed over the ulnar nerve per manufacturer instructions, and the device will be calibrated to obtain baseline Train-of-Four (TOF) measurements. Following rocuronium administration, the device will continuously monitor neuromuscular
• Устройство TwitchView (Blink)-Guided Neuromuscular Monitoring (Dominant Hand)
  The TwitchView (Blink) quantitative electromyography (EMG) neuromuscular monitoring device will be applied to the participant's dominant hand after induction of general anesthesia and prior to administration of neuromuscular blocking agents. Surface electrodes will be placed over the ulnar nerve per manufacturer instructions, and the device will be calibrated to obtain baseline Train-of-Four (TOF) measurements. Following rocuronium administration, neuromuscular function will be continuously moni

Первичные конечные точки

• Incidence of intraoperative diaphragmatic movement during deep neuromuscular blockade [Срок оценки: 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.]
• Incidence of spontaneous breath-initiation efforts during deep neuromuscular blockade [Срок оценки: 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.]

Вторичные конечные точки (10)

• Intubation Difficulty Scale (IDS) score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.]
• Vocal cord movement during intubation [Срок оценки: During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.]
• Post-tetanic count (PTC) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: During emergence from anesthesia, from administration of neuromuscular blockade reversal agent until extubation.]
• Train-of-four ratio before extubation [Срок оценки: Immediately before extubation following completion of surgery and recovery from neuromuscular blockade.]
• System Usability Scale (SUS) score [Срок оценки: Immediately after completion of the intraoperative procedure and device use.]
• Leiden Surgical Rating Scale (L-SRS) score [Срок оценки: At completion of the surgical procedure, prior to emergence from general anesthesia.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• The Ohio State University Wexner Medical Center — Columbus

Публикации

• Kopman AF, Brull SJ. Etiology of Acceleromyographic Train-of-four Overshoot: A Hypothesis. Anesthesiology. 2025 Jun 1;142(6):1171-1173. doi: 10.1097/ALN.0000000000005377. Epub 2025 Apr 7. No abstract available. PMID 40193198
• Blobner M, Frick CG, Stauble RB, Feussner H, Schaller SJ, Unterbuchner C, Lingg C, Geisler M, Fink H. Neuromuscular blockade improves surgical conditions (NISCO). Surg Endosc. 2015 Mar;29(3):627-36. doi: 10.1007/s00464-014-3711-7. Epub 2014 Aug 15. PMID 25125097
• Ahluwalia JS, Morley CJ, Mockridge JN. Computerised determination of spontaneous inspiratory and expiratory times in premature neonates during intermittent positive pressure ventilation. II: Results from 20 babies. Arch Dis Child Fetal Neonatal Ed. 1994 Nov;71(3):F161-4. doi: 10.1136/fn.71.3.f161. PMID 7820709
• Bussey L, Jelacic S, Togashi K, Hulvershorn J, Bowdle A. Train-of-four monitoring with the twitchview monitor electctromyograph compared to the GE NMT electromyograph and manual palpation. J Clin Monit Comput. 2021 Dec;35(6):1477-1483. doi: 10.1007/s10877-020-00615-7. Epub 2020 Nov 9. PMID 33165706
• Matsuda K. [Mechanical properties of dental alloys for clasps]. Kokubyo Gakkai Zasshi. 1976 Jun;43(2):192. No abstract available. Japanese. PMID 792367

Идентификаторы

NCT: NCT07706504 · STUDY20252768

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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