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Neuromuscular BlockadeNCT07706504

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

A study testing TetraGraph (Senzime)-Guided Neuromuscular Monitoring (Dominant Hand) and TwitchView (Blink)-Guided Neuromuscular Monitoring (Dominant Hand) in people with Neuromuscular Blockade, run by Ohio State University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Neuromuscular Blockade
What is being tested?
TetraGraph (Senzime)-Guided Neuromuscular Monitoring (Dominant Hand) and TwitchView (Blink)-Guided Neuromuscular Monitoring (Dominant Hand)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
9 Feb 2026to 9 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43201

    Alberto Uribe, MD, 614-293-0775, alberto.uribe@osumc.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
TetraGraph (Senzime)-Guided Neuromuscular Monitoring (Dominant Hand), TwitchView (Blink)-Guided Neuromuscular Monitoring (Dominant Hand)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT07706504
Study groupRoleWhat they receive
TetraGraph (Senzime) Dominant HandExperimentalParticipants 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.
Receives: Device: TetraGraph (Senzime)-Guided Neuromuscular Monitoring (Dominant Hand)
TwitchView (Blink) Dominant HandExperimentalParticipants 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.
Receives: Device: TwitchView (Blink)-Guided Neuromuscular Monitoring (Dominant Hand)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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)
  1. 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.

    Measured: During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.

  2. 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.

    Measured: During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.

  3. 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.

    Measured: During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.

  4. 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.

    Measured: During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.

  5. 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.

    Measured: Throughout the intraoperative period during maintenance of neuromuscular blockade, from induction of general anesthesia until initiation of emergence from anesthesia.

  6. 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.

    Measured: Throughout the intraoperative period during maintenance of neuromuscular blockade, from induction of general anesthesia until initiation of emergence from anesthesia.

  7. 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.

    Measured: During emergence from anesthesia, from administration of neuromuscular blockade reversal agent until extubation.

  8. 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.

    Measured: Immediately before extubation following completion of surgery and recovery from neuromuscular blockade.

  9. 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.

    Measured: Immediately after completion of the intraoperative procedure and device use.

  10. 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.

    Measured: At completion of the surgical procedure, prior to emergence from general anesthesia.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start9 Feb 2026
  3. Primary completion9 Feb 2028 (estimated)
  4. Study completion9 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07706504
Sponsor's protocol ID
STUDY20252768
Status last verified
May 2026
First submitted
14 May 2026
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 33165706
  • Matsuda K. [Mechanical properties of dental alloys for clasps]. Kokubyo Gakkai Zasshi. 1976 Jun;43(2):192. No abstract available. Japanese.

    PubMed 792367

Questions about this trial

What is this clinical trial studying?

A study testing TetraGraph (Senzime)-Guided Neuromuscular Monitoring (Dominant Hand) and TwitchView (Blink)-Guided Neuromuscular Monitoring (Dominant Hand) in people with Neuromuscular Blockade, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alberto Uribe, MD (6142933559, alberto.uribe@Osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of intraoperative diaphragmatic movement during deep neuromuscular blockade (time frame: 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07706504, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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