Trial Outcomes & Findings for Sugammadex and Quantitative Monitoring in "Fast-Track Anesthesia" During Liver Transplantation (NCT NCT05216991)

NCT ID: NCT05216991

Last Updated: 2025-10-24

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 97 participants
• Primary outcome timeframe: Approximately 10 minutes of surgery recovery period
• Results posted on: 2025-10-24

Participant Flow

67 participants screen failed prior to randomization.

Participant milestones

Measure	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	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
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	TetraGraph monitoring on dominant hand n=15 Participants 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	TetraGraph monitoring on non-dominant hand n=15 Participants 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	Total n=30 Participants Total of all reporting groups
Age, Continuous	56.2 years STANDARD_DEVIATION 8.2 • n=5 Participants	57.9 years STANDARD_DEVIATION 7.5 • n=7 Participants	57.0 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	TetraGraph monitoring on dominant hand n=15 Participants 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	TetraGraph monitoring on non-dominant hand n=15 Participants 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
Incidence of Postoperative Residual Weakness in the Recovery Room	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Number of patients to require ICU admission following liver transplantation

Outcome measures

Measure	TetraGraph monitoring on dominant hand n=15 Participants 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	TetraGraph monitoring on non-dominant hand n=15 Participants 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
ICU Admission	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Average number of days patients are admitted to the hospital following liver transplantation

Outcome measures

Measure	TetraGraph monitoring on dominant hand n=15 Participants 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	TetraGraph monitoring on non-dominant hand n=15 Participants 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
Hospital Length of Stay	6.1 days Standard Deviation 3.2	6.4 days Standard Deviation 2.4

SECONDARY outcome

Timeframe: 30 days

Number of participants who experienced postoperative pulmonary complications defined as pneumonia and respiratory failure

Outcome measures

Measure	TetraGraph monitoring on dominant hand n=15 Participants 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	TetraGraph monitoring on non-dominant hand n=15 Participants 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
Postoperative Pulmonary Complications	0 Participants	0 Participants

Adverse Events

TetraGraph monitoring on dominant hand

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

TetraGraph monitoring on non-dominant hand

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	TetraGraph monitoring on dominant hand n=15 participants at risk 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	TetraGraph monitoring on non-dominant hand n=15 participants at risk 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
Musculoskeletal and connective tissue disorders Postoperative Residual Weakness	13.3% 2/15 • Adverse events were collected from the time of informed consent through study completion, approximately 30 days. Adverse events were collected through specific questioning and/or examination.	0.00% 0/15 • Adverse events were collected from the time of informed consent through study completion, approximately 30 days. Adverse events were collected through specific questioning and/or examination.

Additional Information

J. Ross Renew, M.D.

Mayo Clinic

Phone: 904-956-3328

Email: renew.j@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place