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The purpose of this research is to estimate the frequency of postoperative lasting muscle weakness in patients receiving Sugammadex after undergoing liver transplant surgery by using electromyographic device (EMG), such as TetraGraph.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TetraGraph monitoring on dominant hand | Patients receiving sugammadex after undergoing liver transplantation with quantitative monitoring as standard of care |
| |
| TetraGraph monitoring on non-dominant hand | Patients receiving sugammadex after undergoing liver transplantation with quantitative monitoring as standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TetraGraph on dominant hand | Other | Using standard of care TetraGraph device on dominant hand |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Postoperative Residual Weakness in the Recovery Room | Number of patients to experience postoperative residual weakness after receiving Sugammadex as standard of care for liver transplant surgery. Postoperative residual weakness is defined as train-of-four ratio (TOF) <0.9. Train-of-four is a test used to measure the level of neuromuscular blockage through delivery of four consecutive stimuli to a nerve. Measurement of the muscle's response (number of twitches 1-4) to the stimuli indicates the degree of paralysis. This is measured by an EMG device placed on the thumb which is also part of standard of care for intraoperative assessment of muscle weakness. The ratio is calculated by comparing the amplitude of the fourth twitch to the first twitch. A TOF <0.9 indicates residual weakness, a TOF equal to or greater than 0.9 indicates no residual weakness. | Approximately 10 minutes of surgery recovery period |
| Measure | Description | Time Frame |
|---|---|---|
| ICU Admission | Number of patients to require ICU admission following liver transplantation | 30 days |
| Hospital Length of Stay | Average number of days patients are admitted to the hospital following liver transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing liver transplant surgery at Mayo Clinic in Florida. All study participants will receive their routine standard of care intraoperatively which consists of receiving sugmmadex as part of anesthesia, as well as, monitored with a quantitative monitor device on their dominant or nondominant hand, per standard of care.
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| Name | Affiliation | Role |
|---|---|---|
| J. Ross Renew, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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67 participants screen failed prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | TetraGraph monitoring on dominant hand | Patients who received sugammadex after undergoing liver transplantation with quantitative monitoring as standard of care TetraGraph on dominant hand: Using standard of care TetraGraph device on dominant hand |
| FG001 | TetraGraph monitoring on non-dominant hand | Patients who received sugammadex after undergoing liver transplantation with quantitative monitoring as standard of care TetraGraph on non-dominant hand: Using standard of care TetraGraph device on non-dominant hand |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TetraGraph monitoring on dominant hand | Patients who received sugammadex after undergoing liver transplantation with quantitative monitoring as standard of care TetraGraph on dominant hand: Using standard of care TetraGraph device on dominant hand |
| BG001 | TetraGraph monitoring on non-dominant hand |
| 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 | Incidence of Postoperative Residual Weakness in the Recovery Room | Number of patients to experience postoperative residual weakness after receiving Sugammadex as standard of care for liver transplant surgery. Postoperative residual weakness is defined as train-of-four ratio (TOF) <0.9. Train-of-four is a test used to measure the level of neuromuscular blockage through delivery of four consecutive stimuli to a nerve. Measurement of the muscle's response (number of twitches 1-4) to the stimuli indicates the degree of paralysis. This is measured by an EMG device placed on the thumb which is also part of standard of care for intraoperative assessment of muscle weakness. The ratio is calculated by comparing the amplitude of the fourth twitch to the first twitch. A TOF <0.9 indicates residual weakness, a TOF equal to or greater than 0.9 indicates no residual weakness. | Posted | Count of Participants | Participants | Approximately 10 minutes of surgery recovery period |
|
Adverse events were collected from the time of informed consent through study completion, approximately 30 days.
Adverse events were collected through specific questioning and/or 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 on dominant hand | Patients who received sugammadex after undergoing liver transplantation with quantitative monitoring as standard of care TetraGraph on dominant hand: Using standard of care TetraGraph device on dominant hand |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative Residual Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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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 | Nov 13, 2023 | Sep 16, 2025 | Prot_SAP_000.pdf |
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| TetraGraph on non-dominant hand | Other | Using standard of care TetraGraph device on non-dominant hand |
|
| 30 days |
| Postoperative Pulmonary Complications | Number of participants who experienced postoperative pulmonary complications defined as pneumonia and respiratory failure | 30 days |
Patients who received sugammadex after undergoing liver transplantation with quantitative monitoring as standard of care TetraGraph on non-dominant hand: Using standard of care TetraGraph device on non-dominant hand |
| BG002 | Total | Total of all reporting groups |
| 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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Patients who received sugammadex after undergoing liver transplantation with quantitative monitoring as standard of care TetraGraph on dominant hand: Using standard of care TetraGraph device on dominant hand |
| OG001 | TetraGraph monitoring on non-dominant hand | Patients who received sugammadex after undergoing liver transplantation with quantitative monitoring as standard of care TetraGraph on non-dominant hand: Using standard of care TetraGraph device on non-dominant hand |
|
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| Secondary | ICU Admission | Number of patients to require ICU admission following liver transplantation | Posted | Count of Participants | Participants | 30 days |
|
|
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| Secondary | Hospital Length of Stay | Average number of days patients are admitted to the hospital following liver transplantation | Posted | Mean | Standard Deviation | days | 30 days |
|
|
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| Secondary | Postoperative Pulmonary Complications | Number of participants who experienced postoperative pulmonary complications defined as pneumonia and respiratory failure | Posted | Count of Participants | Participants | 30 days |
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| 0 |
| 15 |
| 0 |
| 15 |
| 2 |
| 15 |
| EG001 | TetraGraph monitoring on non-dominant hand | Patients who received sugammadex after undergoing liver transplantation with quantitative monitoring as standard of care TetraGraph on non-dominant hand: Using standard of care TetraGraph device on non-dominant hand | 0 | 15 | 0 | 15 | 0 | 15 |
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