Trial Outcomes & Findings for TetraGraph in Rocuronium Infusions (NCT NCT06472284)
NCT ID: NCT06472284
Last Updated: 2026-05-13
Results Overview
Amount of rocuronium administered in a bolus dose during induction of anesthesia.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
During the surgery (2-8 hrs.)
Results posted on
2026-05-13
Participant Flow
Participant milestones
| Measure |
Rocuronium Infusion
Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium.
TetraGraph: etraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.
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|---|---|
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Overall Study
STARTED
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50
|
|
Overall Study
COMPLETED
|
48
|
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Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Rocuronium Infusion
Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium.
TetraGraph: etraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.
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|---|---|
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Overall Study
Surgical procedure canceled
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1
|
|
Overall Study
Physician Decision
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1
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Baseline Characteristics
TetraGraph in Rocuronium Infusions
Baseline characteristics by cohort
| Measure |
Rocuronium Infusion
n=48 Participants
Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium.
TetraGraph: etraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.
|
|---|---|
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Age, Categorical
<=18 years
|
48 Participants
n=1512 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=1512 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1512 Participants
|
|
Age, Continuous
|
13 years
n=1512 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=1512 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=1512 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=1512 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=1512 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=1512 Participants
|
|
Height
|
156.6 centimeters
n=1512 Participants
|
|
Weight
|
55.9 kilograms
n=1512 Participants
|
|
Body Mass Index
|
20.6 kg/m^2
n=1512 Participants
|
|
Type of surgical procedure
Cardiac surgery
|
16 Participants
n=1512 Participants
|
|
Type of surgical procedure
Abdominal surgery
|
3 Participants
n=1512 Participants
|
|
Type of surgical procedure
Neurosurgery
|
26 Participants
n=1512 Participants
|
|
Type of surgical procedure
Urology surgery
|
3 Participants
n=1512 Participants
|
PRIMARY outcome
Timeframe: During the surgery (2-8 hrs.)Amount of rocuronium administered in a bolus dose during induction of anesthesia.
Outcome measures
| Measure |
Rocuronium Infusion
n=48 Participants
Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium.
TetraGraph: etraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.
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|---|---|
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Rocuronium Bolus Dose
|
0.8 mg/kg
Interval 0.7 to 1.1
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PRIMARY outcome
Timeframe: During surgery (2-8 hrs.)The amount of rocuronium given by continuous infusion in mg/kg/hr to maintain one twitch of the train of four (TOF)
Outcome measures
| Measure |
Rocuronium Infusion
n=48 Participants
Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium.
TetraGraph: etraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.
|
|---|---|
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Rocuronium Infusion Dose
|
0.48 mg/kg/hr
Interval 0.36 to 0.6
|
PRIMARY outcome
Timeframe: During the surgery (2-8 hrs.)The maximum dose of rocuronium administered by a continuous infusion per patient to maintain one twitch of the train of four (TOF)
Outcome measures
| Measure |
Rocuronium Infusion
n=48 Participants
Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium.
TetraGraph: etraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.
|
|---|---|
|
Maximum Dose of Rocuronium
0.1 to <0.4 mg/kg/hr
|
1 Participants
|
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Maximum Dose of Rocuronium
0.4 to 0.6 mg/kg/hr
|
41 Participants
|
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Maximum Dose of Rocuronium
>0.6 to 0.72 mg/kg/hr
|
6 Participants
|
SECONDARY outcome
Timeframe: During the surgery (2-8 hrs.)Amount of time in minutes that patients received rocuronium infusion.
Outcome measures
| Measure |
Rocuronium Infusion
n=48 Participants
Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium.
TetraGraph: etraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.
|
|---|---|
|
Rocuronium Infusion Time
|
201.5 minutes
Interval 138.5 to 310.0
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SECONDARY outcome
Timeframe: During the surgery (2-8 hrs.)The number of patient that received rescue boluses of rocuronium in addition to the infusion to maintain one twitch of the train of four (TOF)
Outcome measures
| Measure |
Rocuronium Infusion
n=48 Participants
Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium.
TetraGraph: etraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.
|
|---|---|
|
Rocuronium Rescue Boluses
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26 Participants
|
SECONDARY outcome
Timeframe: During the surgery (2-8 hrs.)The total amount of time patients were under anesthesia care in minutes.
Outcome measures
| Measure |
Rocuronium Infusion
n=48 Participants
Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium.
TetraGraph: etraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.
|
|---|---|
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Anesthesia Time
|
339 minutes
Interval 250.0 to 445.5
|
SECONDARY outcome
Timeframe: During the surgery (2-8 hrs.)The total amount of time from first incision to closure in minutes.
Outcome measures
| Measure |
Rocuronium Infusion
n=48 Participants
Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium.
TetraGraph: etraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.
|
|---|---|
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Surgical Time
|
225 minutes
Interval 178.0 to 313.0
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Adverse Events
Rocuronium Infusion
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