Residual Neuromuscular Blockade
Conditions
Keywords
Neuromuscular Blockade, Tetragraph, AMG, EMG
Brief summary
Researchers are comparing the accuracy of measuring muscle relaxation during and after surgery with a device that provides numeric value versus visual observation to count of muscle twitches or absence of them by a medical provider monitoring your anesthesia during surgery.
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
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 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 |
|---|---|---|
| Subjective Evaluation to Neurostimulation | up to 1 hour postoperatively | The percentage of subjective evaluations that overestimated the response of the adductor pollicis muscle following neurostimulation of the ulnar nerve when compared to objective measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Residual Neuromuscular Blockade | Up to 1 hour postoperatively | Number of subjects with train of four ratio \< 0.9 after administration of reversal agent. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dominant Hand Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the dominant hand and routine clinical monitor 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. | 25 |
| Non-dominant Hand Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the non-dominant hand and routine clinical monitor 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. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Unable to obtain readings | 4 | 1 |
Baseline characteristics
| Characteristic | Non-dominant Hand | Total | Dominant Hand |
|---|---|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 16.2 | 57.9 years STANDARD_DEVIATION 14.7 | 57.9 years STANDARD_DEVIATION 13.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 25 participants | 50 participants | 25 participants |
| Sex: Female, Male Female | 17 Participants | 33 Participants | 16 Participants |
| Sex: Female, Male Male | 8 Participants | 17 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Subjective Evaluation to Neurostimulation
The percentage of subjective evaluations that overestimated the response of the adductor pollicis muscle following neurostimulation of the ulnar nerve when compared to objective measurements.
Time frame: up to 1 hour postoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dominant Hand | Subjective Evaluation to Neurostimulation | 48.2 percentage of evaluations |
| Non-dominant Hand | Subjective Evaluation to Neurostimulation | 44.8 percentage of evaluations |
Secondary
Incidence of Residual Neuromuscular Blockade
Number of subjects 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 | 1 Participants |
| Non-dominant Hand | Incidence of Residual Neuromuscular Blockade | 0 Participants |