Liver Transplant SurgeryNCT05216991
Sugammadex and Quantitative Monitoring in "Fast-Track Anesthesia" During Liver Transplantation
An observational study of Liver Transplant Surgery, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Surgery
- What is being tested?
- TetraGraph on dominant hand and TetraGraph on non-dominant hand
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2022to 21 Jan 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patients willing to participate and provide an informed consent.
- Patients undergoing primary liver transplantation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Sugammadex and Quantitative Monitoring in "Fast-Track Anesthesia" During Liver Transplantation
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.
- Conditions
- Liver Transplant Surgery
- Being tested
- TetraGraph on dominant hand, TetraGraph on non-dominant hand
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetraGraph on dominant handOther
Using standard of care TetraGraph device on dominant hand
TetraGraph on non-dominant handOther
Using standard of care TetraGraph device on non-dominant hand
| Study group | Role | What they receive |
|---|---|---|
| TetraGraph monitoring on dominant hand | Patients receiving sugammadex after undergoing liver transplantation with quantitative monitoring as standard of care Receives: Other: TetraGraph on dominant hand | |
| TetraGraph monitoring on non-dominant hand | Patients receiving sugammadex after undergoing liver transplantation with quantitative monitoring as standard of care Receives: Other: TetraGraph on non-dominant hand |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 10 minutes of surgery recovery period
Secondary outcomes (3)
ICU Admission
Number of patients to require ICU admission following liver transplantation
Measured: 30 days
Hospital Length of Stay
Average number of days patients are admitted to the hospital following liver transplantation
Measured: 30 days
Postoperative Pulmonary Complications
Number of participants who experienced postoperative pulmonary complications defined as pneumonia and respiratory failure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start20 Oct 2022
- Primary completion21 Jan 2025
- Study completion21 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver Transplant SurgeryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Ross Renew, M.D., Mayo Clinic
- Investigators
- J. Ross Renew, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216991
- Sponsor's protocol ID
- 21-011838
- Status last verified
- Sep 2025
- First submitted
- 19 Jan 2022
- Last updated
- 24 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sugammadex and Quantitative Monitoring in "Fast-Track Anesthesia" During Liver Transplantation
- ClinicalTrials.gov ID
- NCT05216991
- Acronym / sponsor ID
- 21-011838
- Conditions
- Liver Transplant Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Posted 24 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TetraGraph monitoring on dominant hand | – | Other: TetraGraph on dominant handPatients receiving sugammadex after undergoing liver transplantation with quantitative monitoring as standard of care |
| TetraGraph monitoring on non-dominant hand | – | Other: TetraGraph on non-dominant handPatients receiving sugammadex after undergoing liver transplantation with quantitative monitoring as standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Patients willing to participate and provide an informed consent.
- Patients undergoing primary liver transplantation.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TetraGraph on dominant handUsing standard of care TetraGraph device on dominant hand | Other | TetraGraph monitoring on dominant hand |
| TetraGraph on non-dominant handUsing standard of care TetraGraph device on non-dominant hand | Other | TetraGraph monitoring on non-dominant hand |
Primary outcome
Incidence of Postoperative Residual Weakness in the Recovery Room
Time frame: 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.
3 secondary outcomes
ICU Admission
Time frame: 30 days
Hospital Length of Stay
Time frame: 30 days
Postoperative Pulmonary Complications
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Ross Renew, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant Surgery, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Residual Weakness in the Recovery Room (time frame: Approximately 10 minutes of surgery recovery period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.