Sugammadex and Quantitative Monitoring in "Fast-Track Anesthesia" During Liver Transplantation

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.

Study Overview

• Status: Completed
• Conditions: Liver Transplant Surgery
• Intervention / Treatment: Other: TetraGraph on dominant hand; Other: TetraGraph on non-dominant hand

• Study Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TetraGraph monitoring on dominant hand; Patients receiving sugammadex after undergoing liver transplantation with quantitative monitoring as standard of care	Other: TetraGraph on dominant hand; Using standard of care TetraGraph device on dominant hand
TetraGraph monitoring on non-dominant hand; Patients receiving sugammadex after undergoing liver transplantation with quantitative monitoring as standard of care	Other: TetraGraph on non-dominant hand; Using standard of care TetraGraph device on non-dominant hand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	30 days
Postoperative Pulmonary Complications	Number of participants who experienced postoperative pulmonary complications defined as pneumonia and respiratory failure	30 days

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: J. Ross Renew, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Actual): January 21, 2025
• Study Completion (Actual): January 21, 2025

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Estimated): October 24, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 21-011838

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No