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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: TetraGraph (Senzime) Dominant HandExperimental treatment 1 intervention
Group B: TwitchView (Blink) Dominant HandExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

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.
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.

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.

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

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

Other outcomes

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