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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rocuronium infusion | Experimental | Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TetraGraph | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rocuronium Bolus Dose | Amount of rocuronium administered in a bolus dose during induction of anesthesia. | During the surgery (2-8 hrs.) |
| Rocuronium Infusion Dose | The amount of rocuronium given by continuous infusion in mg/kg/hr to maintain one twitch of the train of four (TOF) | During surgery (2-8 hrs.) |
| Maximum Dose of Rocuronium | The maximum dose of rocuronium administered by a continuous infusion per patient to maintain one twitch of the train of four (TOF) | During the surgery (2-8 hrs.) |
| Measure | Description | Time Frame |
|---|---|---|
| Rocuronium Infusion Time | Amount of time in minutes that patients received rocuronium infusion. | During the surgery (2-8 hrs.) |
| Rocuronium Rescue Boluses | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rocuronium Infusion | Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium. TetraGraph: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rocuronium Infusion | Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium. TetraGraph: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rocuronium Bolus Dose | Amount of rocuronium administered in a bolus dose during induction of anesthesia. | Posted | Median | Inter-Quartile Range | mg/kg | During the surgery (2-8 hrs.) |
|
|
1 Day (day of surgery)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rocuronium Infusion | Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium. TetraGraph: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Tobias | Nationwide Children's Hospital | 614-722-4200 | Joseph.Tobias@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 13, 2024 | Apr 21, 2026 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 13, 2024 | Apr 21, 2026 | SAP_002.pdf |
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|
| During the surgery (2-8 hrs.) |
| Anesthesia Time | The total amount of time patients were under anesthesia care in minutes. | During the surgery (2-8 hrs.) |
| Surgical Time | The total amount of time from first incision to closure in minutes. | During the surgery (2-8 hrs.) |
| Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height | Median | Inter-Quartile Range | centimeters |
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| Weight | Median | Inter-Quartile Range | kilograms |
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| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
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| Type of surgical procedure | Count of Participants | Participants |
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| Counts |
|---|
| Participants |
|
|
| Primary | Rocuronium Infusion Dose | The amount of rocuronium given by continuous infusion in mg/kg/hr to maintain one twitch of the train of four (TOF) | Posted | Median | Inter-Quartile Range | mg/kg/hr | During surgery (2-8 hrs.) |
|
|
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| Primary | Maximum Dose of Rocuronium | The maximum dose of rocuronium administered by a continuous infusion per patient to maintain one twitch of the train of four (TOF) | Posted | Count of Participants | Participants | During the surgery (2-8 hrs.) |
|
|
|
| Secondary | Rocuronium Infusion Time | Amount of time in minutes that patients received rocuronium infusion. | Posted | Median | Inter-Quartile Range | minutes | During the surgery (2-8 hrs.) |
|
|
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| Secondary | Rocuronium Rescue Boluses | 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) | Posted | Count of Participants | Participants | During the surgery (2-8 hrs.) |
|
|
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| Secondary | Anesthesia Time | The total amount of time patients were under anesthesia care in minutes. | Posted | Median | Inter-Quartile Range | minutes | During the surgery (2-8 hrs.) |
|
|
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| Secondary | Surgical Time | The total amount of time from first incision to closure in minutes. | Posted | Median | Inter-Quartile Range | minutes | During the surgery (2-8 hrs.) |
|
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| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
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| Title | Measurements |
|---|---|
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