Surgery
Conditions
Brief summary
This is a prospective, non-blinded study to evaluate rocuronium infusion requirements using the TetraGraph Neuromuscular Transmission Monitor during surgical procedures in patients less than 18 yrs. of age.
Interventions
DEVICETetraGraph
etraGraph 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
28 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients less than 18 years of age * American Society of Anesthesiologists classification (ASA) 1-4 * Patients undergoing a surgical procedure with general anesthesia and requiring the continuous administration of rocuroniuim
Exclusion criteria
* Patients less than 28 days old * Patients with history of a progressive or degenerative peripheral neurologic or neuropathic disorder * Patients undergoing a surgical procedure in which neuromuscular blockade is not required * Edematous patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rocuronium Bolus Dose | During the surgery (2-8 hrs.) | Amount of rocuronium administered in a bolus dose during induction of anesthesia. |
| Rocuronium Infusion Dose | During surgery (2-8 hrs.) | The amount of rocuronium given by continuous infusion in mg/kg/hr to maintain one twitch of the train of four (TOF) |
| Maximum Dose of Rocuronium | During the surgery (2-8 hrs.) | The maximum dose of rocuronium administered by a continuous infusion per patient to maintain one twitch of the train of four (TOF) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rocuronium Infusion Time | During the surgery (2-8 hrs.) | Amount of time in minutes that patients received rocuronium infusion. |
| Rocuronium Rescue Boluses | During the surgery (2-8 hrs.) | The number of patient that received rescue boluses of rocuronium in addition to the infusion to maintain one twitch of the train of four (TOF) |
| Anesthesia Time | During the surgery (2-8 hrs.) | The total amount of time patients were under anesthesia care in minutes. |
| Surgical Time | During the surgery (2-8 hrs.) | The total amount of time from first incision to closure in minutes. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 48 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 13 years |
| Body Mass Index | 20.6 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 156.6 centimeters |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 5 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 | 38 Participants |
| Region of Enrollment United States | 48 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 33 Participants |
| Type of surgical procedure Abdominal surgery | 3 Participants |
| Type of surgical procedure Cardiac surgery | 16 Participants |
| Type of surgical procedure Neurosurgery | 26 Participants |
| Type of surgical procedure Urology surgery | 3 Participants |
| Weight | 55.9 kilograms |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 48 |
| other Total, other adverse events | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
None listed