Residual Neuromuscular Blockade
Conditions
Keywords
Neuromuscular Blockade, ToFscan, Tetragraph, AMG, EMG
Brief summary
The aim of this investigation is to compare the performance of two quantitative monitors utilized on post-anesthesia recovering patients. The ToFscan (Draeger Medical Inc., Telford, PA) represents one of the few standalone acceleromyography (AMG)-based quantitative monitors available for routine clinical use in the United States. The TetraGraph (Senzime AB, Uppsala, Sweden) is a standalone electromyography (EMG)-based quantitative monitor that recently received Conformité Européene (CE) approval. While both of these quantitative monitors can be utilized to guide intraoperative NMBA re-dosing and confirm recovery, they provide their objective data via drastically different techniques.
Interventions
DEVICETetraGraph (TG)
TetraGraph device is a neuromuscular transmission monitor capable of estimating 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 percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.
DEVICEToFscan (TS)
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
SUPPORTIVE_CARE
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 surgical procedure that requires use of non-depolarizing NMBA agents administered intraoperatively.
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 significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Train-of-Four Ratios (TOFR's) | baseline, after 5 minutes, after + 10 minutes | Train-of-four ratios is the ratio of the fourth muscle response to the first one. |
Countries
Hungary, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand TetraGraph was placed on dominant hand, ToFscan was placed on non-dominant hand
TetraGraph device is a neuromuscular transmission monitor capable of estimating 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 percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
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 was measured. | 60 |
| ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand ToFscan was placed on dominant hand, TetraGraph (TG) was placed on non-dominant hand
TetraGraph device is a neuromuscular transmission monitor capable of estimating 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 percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
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 was measured. | 60 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 2 |
Baseline characteristics
| Characteristic | ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand | Total | Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand |
|---|---|---|---|
| Age, Continuous | 55.6 years STANDARD_DEVIATION 15.1 | 55.6 years STANDARD_DEVIATION 15.2 | 55.5 years STANDARD_DEVIATION 15.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 60 participants | 120 participants | 60 participants |
| Sex: Female, Male Female | 38 Participants | 74 Participants | 36 Participants |
| Sex: Female, Male Male | 22 Participants | 46 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 115 | 0 / 115 |
| other Total, other adverse events | 0 / 115 | 0 / 115 |
| serious Total, serious adverse events | 0 / 115 | 0 / 115 |
Outcome results
Primary
Mean Train-of-Four Ratios (TOFR's)
Train-of-four ratios is the ratio of the fourth muscle response to the first one.
Time frame: baseline, after 5 minutes, after + 10 minutes
Population: Dominant arm Train-of-Four Ratios collected for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand | Mean Train-of-Four Ratios (TOFR's) | after + 10 minutes | 0.99 Ratio | Standard Deviation 0.014 |
| Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand | Mean Train-of-Four Ratios (TOFR's) | baseline | 0.97 Ratio | Standard Deviation 0.18 |
| Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand | Mean Train-of-Four Ratios (TOFR's) | after 5 minutes | 0.96 Ratio | Standard Deviation 0.2 |
| ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand | Mean Train-of-Four Ratios (TOFR's) | baseline | 0.94 Ratio | Standard Deviation 0.13 |
| ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand | Mean Train-of-Four Ratios (TOFR's) | after 5 minutes | 0.95 Ratio | Standard Deviation 0.12 |
| ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand | Mean Train-of-Four Ratios (TOFR's) | after + 10 minutes | 0.94 Ratio | Standard Deviation 0.12 |