Residual Neuromuscular Blockade
Conditions
Keywords
Neuromuscular Blockade, Tetragraph, AMG, EMG
Brief summary
Researches are comparing the accuracy of measuring muscle relaxation in the thumb versus the great toe.
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 (ECG) electrodes.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 surgical procedure that requires use of non-depolarizing NMBA agents administered intraoperatively. * Patients with planned administration of sugammadex as a neuromuscular blocking reversal agent.
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 |
|---|---|---|
| Onset Time of Muscle Relaxation for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | Up to 1 hour postoperatively | The amount of time before initial muscle relaxation is recorded via neurostimulation with the Tetragraph device. As measure in seconds. |
| Recover Time for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | Up to 1 hour postoperatively | The amount of time after muscle neurostimulation with the Tetragraph device completion to muscle full recovery. As measure in seconds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | Up to 1 hour postoperatively | The amount of time from reversal agent administered to initial muscle relaxation increase recorded via neurostimulation with the Tetragraph device. As measure in seconds. |
| Recover Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | Up to 1 hour postoperatively | The amount of time after reversal agent administered to muscle full recovery recorded via neurostimulation with the Tetragraph device. As measure in seconds. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dominant Hand and Great Toe Subjects who underwent an elective surgical procedure had TetraGraph device lead placement on the dominant hand and great toe.
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 (ECG) electrodes. | 81 |
| Total | 81 |
Baseline characteristics
| Characteristic | Dominant Hand and Great Toe |
|---|---|
| Age, Continuous | 55.2 years STANDARD_DEVIATION 13.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 73 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 73 Participants |
| Region of Enrollment United States | 81 participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 81 |
| other Total, other adverse events | 0 / 81 |
| serious Total, serious adverse events | 0 / 81 |
Outcome results
Primary
Onset Time of Muscle Relaxation for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles
The amount of time before initial muscle relaxation is recorded via neurostimulation with the Tetragraph device. As measure in seconds.
Time frame: Up to 1 hour postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Flexor Hallucis Brevis (Great Toe) | Onset Time of Muscle Relaxation for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | 180.0 seconds |
| Adductor Pollicis (Thumb) | Onset Time of Muscle Relaxation for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | 180.0 seconds |
Primary
Recover Time for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles
The amount of time after muscle neurostimulation with the Tetragraph device completion to muscle full recovery. As measure in seconds.
Time frame: Up to 1 hour postoperatively
Population: Data was not collected nor analyzed in18 subjects great toes. Data was not collected nor analyzed in 13 subjects thumbs.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Flexor Hallucis Brevis (Great Toe) | Recover Time for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | 180 seconds |
| Adductor Pollicis (Thumb) | Recover Time for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | 180 seconds |
Secondary
Onset Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles
The amount of time from reversal agent administered to initial muscle relaxation increase recorded via neurostimulation with the Tetragraph device. As measure in seconds.
Time frame: Up to 1 hour postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Flexor Hallucis Brevis (Great Toe) | Onset Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | 180.0 seconds |
| Adductor Pollicis (Thumb) | Onset Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | 180.0 seconds |
Secondary
Recover Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles
The amount of time after reversal agent administered to muscle full recovery recorded via neurostimulation with the Tetragraph device. As measure in seconds.
Time frame: Up to 1 hour postoperatively
Population: Data was not collected nor analyzed in 18 subjects great toes. Data was not collected nor analyzed in 13 subjects thumbs.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Flexor Hallucis Brevis (Great Toe) | Recover Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | 180.0 seconds |
| Adductor Pollicis (Thumb) | Recover Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | 180.0 seconds |