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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neuromuscular Blockade
• Intervention / Treatment: Device: TetraGraph (Senzime)-Guided Neuromuscular Monitoring (Dominant Hand); Device: TwitchView (Blink)-Guided Neuromuscular Monitoring (Dominant Hand)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alberto Uribe, MD; Phone Number: 6142933559; Email: alberto.uribe@Osumc.edu
• Study Contact Backup: Name: Elvia Vera, MD; Phone Number: 6142933559; Email: Elvia.VeraMiquilena@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43201
      • Recruiting
      • The Ohio State University Wexner Medical Center
      • Contact: Alberto Uribe, MD; Phone Number: 614-293-0775; Email: alberto.uribe@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TetraGraph (Senzime) Dominant Hand; Participants will have the TetraGraph (Senzime) electromyography (EMG) neuromuscular monitoring device placed on the dominant hand and the TwitchView (Blink) EMG neuromuscular monitoring device placed on the non-dominant hand. The device placed on the dominant hand will be used to guide intraoperative neuromuscular blockade management, while measurements from both devices will be collected for comparison of quantitative neuromuscular monitoring performance.	Device: 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 function, recording TOF approximately every 15 seconds and post-tetanic count (PTC) every 5 minutes when TOF count is zero. As the dominant-hand monitor, its readings will guide rocuronium redosing to maintain deep neuromuscular blockade (PTC 0-3) and assess recovery. During emergence, it will guide reversal, with extubation at TOF ratio ≥0.9.
Experimental: TwitchView (Blink) Dominant Hand; Participants will have the TwitchView (Blink) electromyography (EMG) neuromuscular monitoring device placed on the dominant hand and the TetraGraph (Senzime) EMG neuromuscular monitoring device placed on the non-dominant hand. The device placed on the dominant hand will be used to guide intraoperative neuromuscular blockade management, while measurements from both devices will be collected for comparison of quantitative neuromuscular monitoring performance.	Device: 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 monitored, with TOF recorded approximately every 15 seconds and post-tetanic count (PTC) every 5 minutes when TOF count is zero. As the dominant-hand device, its measurements will guide rocuronium redosing to maintain deep neuromuscular blockade (PTC 0-3) and assess recovery. During emergence, it will guide reversal, with extubation at TOF ratio ≥0.9.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative diaphragmatic movement during deep neuromuscular blockade	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.	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	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation Difficulty Scale (IDS) score	Intubation difficulty will be assessed using the Intubation Difficulty Scale (IDS), a composite score ranging from 0 upward, where 0 represents easy intubation and higher scores indicate greater intubation difficulty.	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	Percentage of participants with patient movement or bucking during tracheal intubation, assessed as a clinical indicator of inadequate neuromuscular blockade.	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	Vocal cord visibility will be assessed during tracheal intubation using the Cormack-Lehane laryngoscopic grading system (Grades I-IV), where Grade I indicates the best glottic view and Grade IV indicates the poorest view.	During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.
Vocal cord movement during intubation	Vocal cord movement will be assessed during tracheal intubation using the predefined study classification (e.g., open, moving, closing, or closed) as an indicator of intubating conditions.	During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.
Post-tetanic count (PTC)	Post-tetanic count (PTC), reported as the number of muscle responses (count), will be measured using the TetraGraph and TwitchView neuromuscular monitoring devices and compared for agreement and correlation.	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	Train-of-four (TOF) count, reported as the number of twitch responses (0-4), will be measured using the TetraGraph and TwitchView devices and compared for agreement and correlation.	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	Time, in minutes, from administration of neuromuscular blockade reversal agent to achievement of a train-of-four (TOF) ratio >0.9, as measured by the TetraGraph and TwitchView devices.	During emergence from anesthesia, from administration of neuromuscular blockade reversal agent until extubation.
Train-of-four ratio before extubation	Train-of-four (TOF) ratio, reported as a decimal value from 0 to 1.0 (or percentage), measured immediately before extubation using the TetraGraph and TwitchView devices. Higher values indicate greater recovery of neuromuscular function.	Immediately before extubation following completion of surgery and recovery from neuromuscular blockade.
System Usability Scale (SUS) score	Anesthesia care providers will evaluate device usability using the System Usability Scale (SUS), which ranges from 0 to 100, with higher scores indicating better perceived usability.	Immediately after completion of the intraoperative procedure and device use.
Leiden Surgical Rating Scale (L-SRS) score	Surgeon-rated surgical conditions will be assessed using the Leiden Surgical Rating Scale (L-SRS), a 5-point ordinal scale ranging from 1 to 5, where 1 indicates extremely poor surgical conditions and 5 indicates optimal surgical conditions. Higher scores indicate better surgical conditions.	At completion of the surgical procedure, prior to emergence from general anesthesia.

Collaborators and Investigators

• Sponsor: Ohio State University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• Matsuda K. [Mechanical properties of dental alloys for clasps]. Kokubyo Gakkai Zasshi. 1976 Jun;43(2):192. No abstract available. Japanese.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2026
• Primary Completion (Estimated): February 9, 2028
• Study Completion (Estimated): August 9, 2028

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STUDY20252768

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No