Trial Outcomes & Findings for Cardiac Output and Recovery Time (NCT NCT04619225)
NCT ID: NCT04619225
Last Updated: 2026-02-04
Results Overview
The correlation between the mean change in cardiac output measurement after reversal with sugammadex to the time it takes to recover from the rocuronium-induced blockade. The Pearson's correlation method was used to calculate the correlation coefficient.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Up to 1 hour postoperative
Results posted on
2026-02-04
Participant Flow
Participant milestones
| Measure |
TetraGraph Monitoring
Subjects scheduled to undergo an elective surgical procedure had TetraGraph device lead placement on either hand at a discretion of the anesthesiologist
TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.
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|---|---|
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Overall Study
STARTED
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7
|
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Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
TetraGraph Monitoring
Subjects scheduled to undergo an elective surgical procedure had TetraGraph device lead placement on either hand at a discretion of the anesthesiologist
TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.
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|---|---|
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Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Cardiac Output and Recovery Time
Baseline characteristics by cohort
| Measure |
TetraGraph Monitoring
n=7 Participants
Subjects scheduled to undergo an elective surgical procedure had TetraGraph device lead placement on either hand at a discretion of the anesthesiologist
TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.
|
|---|---|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 7.8 • n=41 Participants
|
|
Sex: Female, Male
Female
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0 Participants
n=41 Participants
|
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Sex: Female, Male
Male
|
7 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
|
Region of Enrollment
United States
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7 participants
n=41 Participants
|
|
Body Mass Index (BMI)
|
33.5 kg/m^2
STANDARD_DEVIATION 9.39 • n=41 Participants
|
PRIMARY outcome
Timeframe: Up to 1 hour postoperativeThe correlation between the mean change in cardiac output measurement after reversal with sugammadex to the time it takes to recover from the rocuronium-induced blockade. The Pearson's correlation method was used to calculate the correlation coefficient.
Outcome measures
| Measure |
TetraGraph Monitoring
n=5 Participants
Subjects scheduled to undergo an elective surgical procedure had TetraGraph device lead placement on either hand at a discretion of the anesthesiologist
TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.
|
|---|---|
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Recovery Time After Administration of Sugammadex and Its Correlation to Cardiac Output Measure
|
-0.69 Correlation Coefficient
Interval -0.98 to 0.49
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SECONDARY outcome
Timeframe: Up to 1 hour postoperativeThe correlation between the mean change in the speed of recovery from neuromuscular blockade to participant's age. The Pearson's correlation method was used to calculate the correlation coefficient.
Outcome measures
| Measure |
TetraGraph Monitoring
n=5 Participants
Subjects scheduled to undergo an elective surgical procedure had TetraGraph device lead placement on either hand at a discretion of the anesthesiologist
TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.
|
|---|---|
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Correlation of Speed of Recovery From Neuromuscular Blockade and Age.
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-0.464 Correlation Coefficient
Interval -0.955 to 0.708
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Adverse Events
TetraGraph Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place