Neuromuscular Blockade
Conditions
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.
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.
Interventions
DEVICETetraGraph (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.
DEVICETwitchView (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.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Caregiver, Investigator)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative diaphragmatic movement during deep neuromuscular blockade | 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. |
| Incidence of spontaneous breath-initiation efforts during deep neuromuscular blockade | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intubation Difficulty Scale (IDS) score | 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. |
| 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. | Percentage of participants with patient movement or bucking during tracheal intubation, assessed as a clinical indicator of inadequate neuromuscular blockade. |
| 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 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. |
| Vocal cord movement during intubation | 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. |
| Post-tetanic count (PTC) | 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. |
| Train-of-four (TOF) count | 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. |
| Time to recovery of train-of-four ratio >0.9 | 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. |
| Train-of-four ratio before extubation | 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. |
| System Usability Scale (SUS) score | 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. |
| Leiden Surgical Rating Scale (L-SRS) score | 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. |
Countries
United States
Contacts
CONTACTAlberto Uribe, MD
CONTACTElvia Vera, MD
Outcome results
None listed