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

NCT05216991 | Completed Results

• 1 other identifier: 21-011838
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplant Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• ICU Admission

  30 days

• Hospital Length of Stay

  30 days

• Postoperative Pulmonary Complications

  30 days

Study Arms (2)

TetraGraph monitoring on dominant hand

Patients receiving sugammadex after undergoing liver transplantation with quantitative monitoring as standard of care

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

Other: TetraGraph on non-dominant hand

Interventions

TetraGraph on dominant hand OTHER

Using standard of care TetraGraph device on dominant hand

TetraGraph monitoring on dominant hand

TetraGraph on non-dominant hand OTHER

Using standard of care TetraGraph device on non-dominant hand

TetraGraph monitoring on non-dominant hand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients willing to participate and provide an informed consent.
• Patients undergoing primary liver transplantation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Results Point of Contact

• Title: J. Ross Renew, M.D.
• Organization: Mayo Clinic

renew.j@mayo.edu

904-956-3328

Study Officials

• J. Ross Renew, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 1, 2022
• Study Start: October 20, 2022
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: October 24, 2025
• Results First Posted: October 24, 2025

Record last verified: 2025-09

Locations

US (1)