Residual Neuromuscular Blockade
Conditions
Keywords
Neuromuscular Blockade, Tetragraph, AMG, EMG
Brief summary
Researchers are comparing the ease of use and repeatability of the force vs electrical activity produced by a muscle after it has undergone nerve stimulation during a surgical procedure in which the patients' arm movement is restricted (placed under surgical drapes) in laparoscopic or robotic procedures.
Interventions
DEVICETetragraph
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.
DEVICEToFscan
ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three-dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> or = 18 years old * Patients willing to participate and provide an informed consent * Patients undergoing an elective laparoscopic or robotic surgical procedure that requires use of NMBA agents administered intraoperatively.
Exclusion criteria
* Patients with 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 significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease. * Patients having surgery that would involve prepping the arm or leg into the sterile field
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Values Between Tetragraph and ToFscan | Up to 1 hour postoperatively | The number of subject's who's residual neuromuscular blockage units are the same on both the TetraGraph and the ToFscan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Residual Neuromuscular Blockade | Up to 1 hour postoperatively | Number of patients with train of four ratio \< 0.9 after administration of reversal agent. |
Countries
France, Hungary, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dominant Hand Subject who received an elective surgical procedure had TetraGraph device lead placement on the dominant hand, ToFscan placed on non-dominant hand
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.
ToFscan: ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three-dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured | 30 |
| Non-dominant Hand Subject who received an elective surgical procedure had TetraGraph device lead placement on the non-dominant hand, ToFscan placed on dominant hand
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.
ToFscan: ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three-dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Dominant Hand | Non-dominant Hand | Total |
|---|---|---|---|
| Age, Continuous | 60.2 years STANDARD_DEVIATION 12.49 | 60.6 years STANDARD_DEVIATION 14.04 | 60.37 years STANDARD_DEVIATION 13.18 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 29 Participants | 57 Participants |
| Region of Enrollment Hungary | 15 participants | 15 participants | 30 participants |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 25 Participants |
| Sex: Female, Male Male | 17 Participants | 18 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Accuracy of Values Between Tetragraph and ToFscan
The number of subject's who's residual neuromuscular blockage units are the same on both the TetraGraph and the ToFscan
Time frame: Up to 1 hour postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dominant Hand | Accuracy of Values Between Tetragraph and ToFscan | 0 Participants |
| Non-dominant Hand | Accuracy of Values Between Tetragraph and ToFscan | 2 Participants |
Secondary
Incidence of Residual Neuromuscular Blockade
Number of patients with train of four ratio \< 0.9 after administration of reversal agent.
Time frame: Up to 1 hour postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dominant Hand | Incidence of Residual Neuromuscular Blockade | 3 Participants |
| Non-dominant Hand | Incidence of Residual Neuromuscular Blockade | 2 Participants |