Liver Transplant Surgery
Conditions
Brief summary
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.
Interventions
OTHERTetraGraph on dominant hand
Using standard of care TetraGraph device on dominant hand
OTHERTetraGraph on non-dominant hand
Using standard of care TetraGraph device on non-dominant hand
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients willing to participate and provide an informed consent. * Patients undergoing primary liver transplantation.
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 a known history of cerebrovascular accident (CVA). * Patients undergoing repeat liver transplantation or concomitant pancreas/kidney transplantation at the time of liver transplantation. * Patients admitted to the intensive care unit prior to liver transplantation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Residual Weakness in the Recovery Room | Approximately 10 minutes of surgery recovery period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU Admission | 30 days | Number of patients to require ICU admission following liver transplantation |
| Hospital Length of Stay | 30 days | Average number of days patients are admitted to the hospital following liver transplantation |
| Postoperative Pulmonary Complications | 30 days | Number of participants who experienced postoperative pulmonary complications defined as pneumonia and respiratory failure |
Countries
United States
Participant flow
Pre-assignment details
67 participants screen failed prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | TetraGraph monitoring on dominant hand | Total | TetraGraph monitoring on non-dominant hand |
|---|---|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 8.2 | 57.0 years STANDARD_DEVIATION 7.8 | 57.9 years STANDARD_DEVIATION 7.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 27 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 29 Participants | 14 Participants |
| Region of Enrollment United States | 15 participants | 30 participants | 15 participants |
| Sex: Female, Male Female | 4 Participants | 10 Participants | 6 Participants |
| Sex: Female, Male Male | 11 Participants | 20 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 2 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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.
Time frame: Approximately 10 minutes of surgery recovery period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TetraGraph monitoring on dominant hand | Incidence of Postoperative Residual Weakness in the Recovery Room | 2 Participants |
| TetraGraph monitoring on non-dominant hand | Incidence of Postoperative Residual Weakness in the Recovery Room | 0 Participants |
Secondary
Hospital Length of Stay
Average number of days patients are admitted to the hospital following liver transplantation
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TetraGraph monitoring on dominant hand | Hospital Length of Stay | 6.1 days | Standard Deviation 3.2 |
| TetraGraph monitoring on non-dominant hand | Hospital Length of Stay | 6.4 days | Standard Deviation 2.4 |
Secondary
ICU Admission
Number of patients to require ICU admission following liver transplantation
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TetraGraph monitoring on dominant hand | ICU Admission | 2 Participants |
| TetraGraph monitoring on non-dominant hand | ICU Admission | 0 Participants |
Secondary
Postoperative Pulmonary Complications
Number of participants who experienced postoperative pulmonary complications defined as pneumonia and respiratory failure
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TetraGraph monitoring on dominant hand | Postoperative Pulmonary Complications | 0 Participants |
| TetraGraph monitoring on non-dominant hand | Postoperative Pulmonary Complications | 0 Participants |