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Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit

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ClinicalTrials.gov Identifier: NCT03920670
Recruitment Status : Completed
First Posted : April 19, 2019
Results First Posted : April 29, 2021
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
J. Ross Renew, M.D., Mayo Clinic

Brief Summary:
The aim of this investigation is to compare the performance of two quantitative monitors utilized on post-anesthesia recovering patients. The ToFscan (Draeger Medical Inc., Telford, PA) represents one of the few standalone acceleromyography (AMG)-based quantitative monitors available for routine clinical use in the United States. The TetraGraph (Senzime AB, Uppsala, Sweden) is a standalone electromyography (EMG)-based quantitative monitor that recently received Conformité Européene (CE) approval. While both of these quantitative monitors can be utilized to guide intraoperative NMBA re-dosing and confirm recovery, they provide their objective data via drastically different techniques.

Condition or disease Intervention/treatment Phase
Residual Neuromuscular Blockade Device: TetraGraph (TG) Device: ToFscan (TS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit
Actual Study Start Date : February 28, 2019
Actual Primary Completion Date : November 30, 2020
Actual Study Completion Date : November 30, 2020

Arm Intervention/treatment
Experimental: Tetragraph (TG)
TetraGraph placed on dominant hand, ToFscan placed on non-dominant hand
Device: TetraGraph (TG)
TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.

Device: ToFscan (TS)
ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three-dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.

Active Comparator: ToFscan (TS)
ToFscan placed on dominant hand, TetraGraph (TG) placed on non-dominant hand
Device: TetraGraph (TG)
TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.

Device: ToFscan (TS)
ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three-dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.




Primary Outcome Measures :
  1. Mean Train-of-Four Ratios (TOFR's) [ Time Frame: baseline, after 5 minutes, after + 10 minutes ]
    Train-of-four ratios is the ratio of the fourth muscle response to the first one.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Age > or = 18 years old
  • Patients willing to participate and provide an informed consent
  • Patients undergoing an elective surgical procedure that requires use of non-depolarizing NMBA agents administered intraoperatively.

Exclusion Criteria

  • Patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
  • Patients with systemic neuromuscular diseases such as myasthenia gravis
  • Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920670


Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Hungary
University of Debrecen
Debrecen, Hungary, 4031
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: J Ross Renew, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by J. Ross Renew, M.D., Mayo Clinic:
Additional Information:
Publications:
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Responsible Party: J. Ross Renew, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03920670    
Other Study ID Numbers: 18-011298
First Posted: April 19, 2019    Key Record Dates
Results First Posted: April 29, 2021
Last Update Posted: April 29, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by J. Ross Renew, M.D., Mayo Clinic:
Neuromuscular Blockade
ToFscan
Tetragraph
AMG
EMG
Additional relevant MeSH terms:
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Delayed Emergence from Anesthesia
Postoperative Complications
Pathologic Processes