Surgery
Conditions
Brief summary
This is a prospective study that will evaluate the feasibility of using the Tetragraph Neuromuscular Transmission Monitor in comparison to standard (visual) train-of-four assessment with a peripheral nerve stimulator in pediatric patients undergoing surgery.
Interventions
TetraGraph 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.
Sponsors
Joseph D. Tobias
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients requiring anesthetic care and use of neuromuscular blockade * Weight range of 20 - 60 kg
Exclusion criteria
* Patients with history of a peripheral neurologic or neuropathic disorder * Patients in whom the upper extremity cannot be used for TOF monitoring * Patients undergoing a surgical procedure in which neuromuscular blockade is not required * Edematous patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline TOFr (%) | Immediately prior to start of surgery | Train of four (TOF) is measured by giving 4 quick electrical pulses to the muscle and counting the number of muscle twitches. Baseline TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) prior to administration of the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A lower TOFr equals stronger neuromuscular block and more muscle paralysis. |
| Recovered TOFr (%) | At the end of surgery (maximum 7 hours from baseline) | Train of four (TOF) is measured by giving 4 quick electrical pulses to the muscle and counting the number of muscle twitches. Recovered TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) after recovery from the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A TOFr greater than or equal to 90% indicates adequate recovery from the neuromuscular block. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Amplitude (mV) | Immediately prior to start of surgery | The amplitude of the muscle action potential prior to administration of the neuromuscular blocking agent. |
| Recovered Amplitude (mV) | At the end of surgery (maximum 7 hours from baseline) | The amplitude of the muscle action potential after recovery from the neuromuscular blocking agent. |
| Rate of Muscle Recovery (Minutes) | At the end of surgery (maximum 7 hours from baseline) | The amount of time it took to return to a TOFr \>90% following reversal of neuromuscular blocking agent. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tetragraph Tetragraph (TM) NMT Monitor: TetraGraph 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. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Tetragraph |
|---|---|
| Age, Categorical <=18 years | 100 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 11 years STANDARD_DEVIATION 3 |
| Body mass index (BMI) | 18.7 kg/m2 STANDARD_DEVIATION 3.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 145 centimeters STANDARD_DEVIATION 16 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 90 Participants |
| Region of Enrollment United States | 100 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 62 Participants |
| Weight | 39.5 kilograms STANDARD_DEVIATION 10.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Baseline TOFr (%)
Train of four (TOF) is measured by giving 4 quick electrical pulses to the muscle and counting the number of muscle twitches. Baseline TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) prior to administration of the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A lower TOFr equals stronger neuromuscular block and more muscle paralysis.
Time frame: Immediately prior to start of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetragraph | Baseline TOFr (%) | 100.1 percent | Standard Deviation 8.4 |
Primary
Recovered TOFr (%)
Train of four (TOF) is measured by giving 4 quick electrical pulses to the muscle and counting the number of muscle twitches. Recovered TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) after recovery from the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A TOFr greater than or equal to 90% indicates adequate recovery from the neuromuscular block.
Time frame: At the end of surgery (maximum 7 hours from baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetragraph | Recovered TOFr (%) | 90.1 percent | Standard Deviation 13.1 |
Secondary
Baseline Amplitude (mV)
The amplitude of the muscle action potential prior to administration of the neuromuscular blocking agent.
Time frame: Immediately prior to start of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetragraph | Baseline Amplitude (mV) | 7.5 millivolts | Standard Deviation 2.4 |
Secondary
Rate of Muscle Recovery (Minutes)
The amount of time it took to return to a TOFr \>90% following reversal of neuromuscular blocking agent.
Time frame: At the end of surgery (maximum 7 hours from baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetragraph | Rate of Muscle Recovery (Minutes) | 2.6 minutes | Standard Deviation 1.4 |
Secondary
Recovered Amplitude (mV)
The amplitude of the muscle action potential after recovery from the neuromuscular blocking agent.
Time frame: At the end of surgery (maximum 7 hours from baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetragraph | Recovered Amplitude (mV) | 6.5 millivolts | Standard Deviation 2 |