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

NCT07706504 | Recruiting FDA Device

• 1 other identifier: STUDY20252768
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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.

Study Arms (2)

TetraGraph (Senzime) Dominant Hand

EXPERIMENTAL

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)

TwitchView (Blink) Dominant Hand

EXPERIMENTAL

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)

Interventions

TetraGraph (Senzime)-Guided Neuromuscular Monitoring (Dominant Hand) DEVICE

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.

TetraGraph (Senzime) Dominant Hand

TwitchView (Blink)-Guided Neuromuscular Monitoring (Dominant Hand) DEVICE

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.

TwitchView (Blink) Dominant Hand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43201, United States

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 RESULT

• 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 RESULT

• 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 RESULT

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

  PMID: 792367 RESULT

Central Study Contacts

Alberto Uribe, MD

CONTACT

6142933559; alberto.uribe@Osumc.edu

Elvia Vera, MD

CONTACT

6142933559; Elvia.VeraMiquilena@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Anesthesiology

Model Details: Prospective randomized within-subject comparative device study. All participants will have both TetraGraph and TwitchView EMG monitors applied simultaneously. Randomization determines which device is placed on the dominant hand and used to guide neuromuscular blockade management; the other device is placed on the non-dominant hand for comparison.

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: July 15, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): February 9, 2028
• Study Completion (Estimated): August 9, 2028
• Last Updated: July 15, 2026

Record last verified: 2026-05

Locations

US (1)