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Researches are comparing the accuracy of measuring muscle relaxation in the thumb versus the great toe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dominant Hand and great toe | Experimental | Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the dominant hand and great toe. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TetraGraph | Device | FDA approved neuromuscular transmission monitor capable of measuring 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 electrical neurostimulation via skin (ECG) electrodes. |
| Measure | Description | Time Frame |
|---|---|---|
| Onset Time of Muscle Relaxation for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | The amount of time before initial muscle relaxation is recorded via neurostimulation with the Tetragraph device. As measure in seconds. | Up to 1 hour postoperatively |
| Recover Time for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | The amount of time after muscle neurostimulation with the Tetragraph device completion to muscle full recovery. As measure in seconds. | Up to 1 hour postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Onset Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | The amount of time from reversal agent administered to initial muscle relaxation increase recorded via neurostimulation with the Tetragraph device. As measure in seconds. | Up to 1 hour postoperatively |
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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 |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dominant Hand and Great Toe | Subjects who underwent an elective surgical procedure had TetraGraph device lead placement on the dominant hand and great toe. TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring 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 electrical neurostimulation via skin (ECG) electrodes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dominant Hand and Great Toe | Subjects who underwent an elective surgical procedure had TetraGraph device lead placement on the dominant hand and great toe. TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring 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 electrical neurostimulation via skin (ECG) electrodes. |
| 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 | Onset Time of Muscle Relaxation for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | The amount of time before initial muscle relaxation is recorded via neurostimulation with the Tetragraph device. As measure in seconds. | Posted | Median | Full Range | seconds | Up to 1 hour postoperatively |
|
Adverse Events were collected from baseline to end of study, approximately one hour
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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 | Dominant Hand and Great Toe | Subjects who underwent an elective surgical procedure had TetraGraph device lead placement on the dominant hand and great toe. TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring 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 electrical neurostimulation via skin (ECG) electrodes. |
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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 | Jan 15, 2021 | Nov 9, 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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|
| Recover Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles |
The amount of time after reversal agent administered to muscle full recovery recorded via neurostimulation with the Tetragraph device. As measure in seconds. |
| Up to 1 hour postoperatively |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Recover Time for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | The amount of time after muscle neurostimulation with the Tetragraph device completion to muscle full recovery. As measure in seconds. | Data was not collected nor analyzed in18 subjects great toes. Data was not collected nor analyzed in 13 subjects thumbs. | Posted | Median | Full Range | seconds | Up to 1 hour postoperatively |
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| Secondary | Onset Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | The amount of time from reversal agent administered to initial muscle relaxation increase recorded via neurostimulation with the Tetragraph device. As measure in seconds. | Posted | Median | Full Range | seconds | Up to 1 hour postoperatively |
|
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| Secondary | Recover Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | The amount of time after reversal agent administered to muscle full recovery recorded via neurostimulation with the Tetragraph device. As measure in seconds. | Data was not collected nor analyzed in 18 subjects great toes. Data was not collected nor analyzed in 13 subjects thumbs. | Posted | Median | Full Range | seconds | Up to 1 hour postoperatively |
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| 0 |
| 81 |
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| 81 |
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| 81 |
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