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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tetragraph (TG) | Experimental | TetraGraph placed on dominant hand, ToFscan placed on non-dominant hand |
|
| ToFscan (TS) | Active Comparator | ToFscan placed on dominant hand, TetraGraph (TG) placed on non-dominant hand |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TetraGraph (TG) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Train-of-Four Ratios (TOFR's) | Train-of-four ratios is the ratio of the fourth muscle response to the first one. | baseline, after 5 minutes, after + 10 minutes |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| J Ross Renew, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States | ||
| NorthShore University HealthSystem |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30130260 | Background | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand | TetraGraph was placed on dominant hand, ToFscan (TS) was placed on non-dominant hand 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 was measured. 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 was measured. |
| FG001 | ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand | ToFscan was placed on dominant hand, TetraGraph (TG) was placed on non-dominant hand 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 was measured. 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 was measured. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand | TetraGraph was placed on dominant hand, ToFscan was placed on non-dominant hand 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 was measured. 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 was measured. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Train-of-Four Ratios (TOFR's) | Train-of-four ratios is the ratio of the fourth muscle response to the first one. | Dominant arm Train-of-Four Ratios collected for analysis | Posted | Mean | Standard Deviation | Ratio | baseline, after 5 minutes, after + 10 minutes |
|
Adverse events were collected from baseline to end of scan, for a total of approximately 10 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand | TetraGraph was placed on dominant hand, ToFscan was placed on non-dominant hand TetraGraph (TG): AMG and EMG neuromuscular blockade monitoring. The TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured. ToFscan (TS): Neuromuscular transmission monitor. A measure of muscle relaxation on an anesthetized subjects. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Ross Renew, M.D. | Mayo Clinic | 904-956-3328 | Renew.J@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 11, 2019 | Feb 26, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055191 | Delayed Emergence from Anesthesia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| ToFscan (TS) | Device | 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. |
|
| Evanston |
| Illinois |
| 60201 |
| United States |
| University of Debrecen | Debrecen | 4031 | Hungary |
| BG001 | ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand | ToFscan was placed on dominant hand, TetraGraph (TG) was placed on non-dominant hand 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 was measured. 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 was measured. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand | ToFscan was placed on dominant hand, TetraGraph (TG) was placed on non-dominant hand 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 was measured. 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 was measured. Dominant arm Train-of-Four Ratios collected for analysis |
|
|
| 0 |
| 115 |
| 0 |
| 115 |
| 0 |
| 115 |
| EG001 | ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand | ToFscan was placed on dominant hand, TetraGraph (TG) was placed on non-dominant hand TetraGraph (TG): AMG and EMG neuromuscular blockade monitoring. The TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured. ToFscan (TS): Neuromuscular transmission monitor. A measure of muscle relaxation on an anesthetized subjects. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured. | 0 | 115 | 0 | 115 | 0 | 115 |
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