Surgery
Conditions
Brief summary
The primary objective of this study is to evaluate the efficacy of train-of-four (TOF) monitoring using the TetraGraph Neuromuscular Transmission Monitor in pediatric patients less than 1 year of age.
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
1 Months to 12 Months
Healthy volunteers
No
Inclusion criteria
* ASA 1-4 * ≤ 1 year of age * undergoing a surgical procedure with general anesthesia and requiring the administration of an NMBA
Exclusion criteria
* Patients less than 28 days old * 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 |
|---|---|---|
| TOFr (%) | During the surgery (1-3 hrs. avg.) | The Train of Four ratio (TOFr) is a quantitative measure used in anesthesia to assess the depth of neuromuscular blockade and recovery, calculated by dividing the amplitude of the fourth twitch by the first twitch after four 2-Hz stimuli. A TOF ratio is the standard threshold for safe extubation and indicates sufficient recovery from nondepolarizing agents. A TOF ratio \>/= 90% is the standard threshold for safe extubation and indicates sufficient recovery from nondepolarizing agents. |
| Amplitude | During the surgery (1-3 hrs. avg.) | The amplitude of the muscle action potential in response to electrical stimulation of its corresponding peripheral nerve. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Muscle Recovery | Baseline, After reversal of neuromuscular blockade during surgery (avg of 1-3 hrs) | The amount of time from administration of neuromuscular blockade reversal agent to muscle recovery (TOFr \>/= 90). |
Countries
United States
Participant flow
Pre-assignment details
One subject was excluded from the study prior to the TetraGraph being placed because the surgeon decided a neuromuscular blocking agent was not required clinically to complete the surgery. All other subjects were placed in the TetraGraph group.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 5.45 months STANDARD_DEVIATION 2.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Participants per weight group 0 to <4 kg | 3 Participants |
| Participants per weight group 4 to <6 kg | 20 Participants |
| Participants per weight group 6 to <8 kg | 16 Participants |
| Participants per weight group More than 8 kg | 10 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 | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 49 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 28 Participants |
| Weight | 3.1 kilograms STANDARD_DEVIATION 1.83 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 49 |
| other Total, other adverse events | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 |
Outcome results
None listed