Recruiting

TetraGraph & TwitchView

Sponsor:

Ohio State University

Code:

NCT07706504

Conditions

Neuromuscular Blockade

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

TetraGraph (Senzime)-Guided Neuromuscular Monitoring (Dominant Hand)

TwitchView (Blink)-Guided Neuromuscular Monitoring (Dominant Hand)

Study Details

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.

Conditions

Neuromuscular Blockade

Study ID

NCT07706504

Start date

Feb 9, 2026

Status verified date

May, 2026

Completion date

Aug 9, 2028

Anticipated

Primary completion date

Feb 9, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Alberto Uribe, MD

6142933559alberto.uribe@Osumc.edu

Elvia Vera, MD

6142933559Elvia.VeraMiquilena@osumc.edu

Locations

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43201

Contacts

Alberto Uribe, MD

614-293-0775alberto.uribe@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Jul 15, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-07-15.