Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit
Primary Purpose
Residual Neuromuscular Blockade
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
TetraGraph (TG)
ToFscan (TS)
Sponsored by
About this trial
This is an interventional supportive care trial for Residual Neuromuscular Blockade focused on measuring Neuromuscular Blockade, ToFscan, Tetragraph, AMG, EMG
Eligibility 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.
Sites / Locations
- Mayo Clinic in Florida
- NorthShore University HealthSystem
- University of Debrecen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tetragraph (TG)
ToFscan (TS)
Arm Description
TetraGraph placed on dominant hand, ToFscan placed on non-dominant hand
ToFscan placed on dominant hand, TetraGraph (TG) placed on non-dominant hand
Outcomes
Primary Outcome Measures
Mean Train-of-Four Ratios (TOFR's)
Train-of-four ratios is the ratio of the fourth muscle response to the first one.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03920670
Brief Title
Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit
Official Title
Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Residual Neuromuscular Blockade
Keywords
Neuromuscular Blockade, ToFscan, Tetragraph, AMG, EMG
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tetragraph (TG)
Arm Type
Experimental
Arm Description
TetraGraph placed on dominant hand, ToFscan placed on non-dominant hand
Arm Title
ToFscan (TS)
Arm Type
Active Comparator
Arm Description
ToFscan placed on dominant hand, TetraGraph (TG) placed on non-dominant hand
Intervention Type
Device
Intervention Name(s)
TetraGraph (TG)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
ToFscan (TS)
Intervention Description
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 Measure Information:
Title
Mean Train-of-Four Ratios (TOFR's)
Description
Train-of-four ratios is the ratio of the fourth muscle response to the first one.
Time Frame
baseline, after 5 minutes, after + 10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J Ross Renew, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
University of Debrecen
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
12. IPD Sharing Statement
Citations:
PubMed Identifier
30130260
Citation
Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur M, Benson J, Newmark RL, Maher CE. Comparison of the TOFscan and the TOF-Watch SX during Recovery of Neuromuscular Function. Anesthesiology. 2018 Nov;129(5):880-888. doi: 10.1097/ALN.0000000000002400.
Results Reference
background
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit
We'll reach out to this number within 24 hrs