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

• Conditions: Liver Transplant Surgery
• Interventions: Other: TetraGraph on dominant hand; Other: TetraGraph on non-dominant hand

• Registration Number: NCT05216991
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-02-01
• Study Start: 2022-10-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TetraGraph monitoring on dominant hand	TetraGraph on dominant hand	Patients receiving sugammadex after undergoing liver transplantation with quantitative monitoring as standard of care
TetraGraph monitoring on non-dominant hand	TetraGraph on non-dominant hand	Patients receiving sugammadex after undergoing liver transplantation with quantitative monitoring as standard of care

Primary Outcome Measures

Name	Time	Method
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 \<0.9 measured by an EMG device placed on the thumb which is also part of standard of care for intraoperative assessment of muscle weakness.

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	30 days	Total number of days patients are admitted to the hospital following liver transplantation
Postoperative pulmonary complications	30 days	Number of postoperative pulmonary complications defined as pneumonia and respiratory failure
ICU Admission	30 days	Number of patients to require ICU admission following liver transplantation

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States