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

9 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

35

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • Ohio
      • Columbus, Ohio, États-Unis, 43201
        • Recrutement
        • The Ohio State University Wexner Medical Center
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: 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.
Expérimental: 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.
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of intraoperative diaphragmatic movement during deep neuromuscular blockade
Délai: 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
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Intubation Difficulty Scale (IDS) score
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ohio State University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

9 février 2026

Achèvement primaire (Estimé)

9 février 2028

Achèvement de l'étude (Estimé)

9 août 2028

Dates d'inscription aux études

Première soumission

14 mai 2026

Première soumission répondant aux critères de contrôle qualité

9 juillet 2026

Première publication (Réel)

15 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 juillet 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • STUDY20252768

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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