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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03920670
Recruitment Status : Enrolling by invitation
First Posted : April 19, 2019
Last Update Posted : January 13, 2020
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: Neuromuscular stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : January 30, 2022

Arm Intervention/treatment
Experimental: Group 1
TetraGraph on dominant arm, ToFscan on non-dominant arm
Device: Neuromuscular stimulation
AMG and EMG neuromuscular blockade monitoring

Active Comparator: Group 2
TetraGraph on non-dominant arm, ToFscan on dominant arm
Device: Neuromuscular stimulation
AMG and EMG neuromuscular blockade monitoring




Primary Outcome Measures :
  1. Consistency in values obtained by ToFscan and TetraGraph [ Time Frame: up to 10 hours postoperatively ]
    Obtain ToFscan values and TetraGraph values simultaneously in the recovery period simultaneously (same measuring units).


Secondary Outcome Measures :
  1. Number of patients with incomplete neuromuscular blockade reversal [ Time Frame: up to 10 hours postoperatively ]
    Identify patients who demonstrate TOF reading below 90% in the recovery period

  2. Patient's reported discomfort with use of devices [ Time Frame: up to 10 hours postoperatively ]
    Number of patients reporting discomfort associated with use of either device



Information from the National Library of Medicine

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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
Additional Information:
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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
Last Update Posted: January 13, 2020
Last Verified: January 2020

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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