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

July 9, 2026 updated by: Boris Mraovic, Ohio State University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

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  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43201
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 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
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 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intubation Difficulty Scale (IDS) score
Time Frame: During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.
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
Time Frame: During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.
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
Time Frame: During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.
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
Time Frame: During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.
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)
Time Frame: Throughout the intraoperative period during maintenance of neuromuscular blockade, from induction of general anesthesia until initiation of emergence from anesthesia.
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
Time Frame: 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, 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 Frame: During emergence from anesthesia, from administration of neuromuscular blockade reversal agent until extubation.
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
Time Frame: Immediately before extubation following completion of surgery and recovery from neuromuscular blockade.
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
Time Frame: Immediately after completion of the intraoperative procedure and device use.
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
Time Frame: At completion of the surgical procedure, prior to emergence from general anesthesia.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 9, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 9, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

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  • 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

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