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lack of interest
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The purpose of this research is to determine the time it takes to reverse the effects of the intraoperative medication given to relax the muscles and how this period of recovery correlates with a function of the heart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TetraGraph monitoring | Experimental | Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on either hand at a discretion of the anesthesiologist |
|
| 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 electrodes. |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery Time After Administration of Sugammadex and Its Correlation to Cardiac Output Measure | The correlation between the mean change in cardiac output measurement after reversal with sugammadex to the time it takes to recover from the rocuronium-induced blockade. The Pearson's correlation method was used to calculate the correlation coefficient. | Up to 1 hour postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Speed of Recovery From Neuromuscular Blockade and Age. | The correlation between the mean change in the speed of recovery from neuromuscular blockade to participant's age. The Pearson's correlation method was used to calculate the correlation coefficient. | Up to 1 hour postoperative |
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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 | 32223 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | TetraGraph Monitoring | Subjects scheduled to undergo an elective surgical procedure had TetraGraph device lead placement on either hand at a discretion of the anesthesiologist 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 electrodes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TetraGraph Monitoring | Subjects scheduled to undergo an elective surgical procedure had TetraGraph device lead placement on either hand at a discretion of the anesthesiologist 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 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 | Recovery Time After Administration of Sugammadex and Its Correlation to Cardiac Output Measure | The correlation between the mean change in cardiac output measurement after reversal with sugammadex to the time it takes to recover from the rocuronium-induced blockade. The Pearson's correlation method was used to calculate the correlation coefficient. | Posted | Number | 95% Confidence Interval | Correlation Coefficient | Up to 1 hour postoperative |
|
Adverse events were collected from the time of informed consent through up to 10 minutes after arrival to Post-Anesthesia Care Unit (PACU) or when Train of Four (TOF) ratio was > 0.9 (whichever occurred first).
Adverse events were collected through specific questioning and, as appropriate, by examination.
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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 Monitoring | Subjects scheduled to undergo an elective surgical procedure had TetraGraph device lead placement on either hand at a discretion of the anesthesiologist 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 electrodes. |
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The study was terminated early due to a lack of interest.
| 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 | Aug 17, 2022 | Jan 20, 2026 | 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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|
| 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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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Secondary | Correlation of Speed of Recovery From Neuromuscular Blockade and Age. | The correlation between the mean change in the speed of recovery from neuromuscular blockade to participant's age. The Pearson's correlation method was used to calculate the correlation coefficient. | Posted | Number | 95% Confidence Interval | Correlation Coefficient | Up to 1 hour postoperative |
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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