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The purpose of this study is to determine if intravenous fosaprepitant can interfere with nervous system monitoring signals in patients having surgery under general anesthesia. This medication has numerous effects on the sensory nerve transmission which can theoretically have effects on the ability to accurately measure somatosensory evoked potentials.
The purpose of this study is to determine if intravenous fosaprepitant can interfere with nervous system monitoring signals in patients having surgery under general anesthesia. Fosaprepitant is a drug commonly used to prevent post-operative nausea and vomiting, and works by inhibiting "substance P", which is found in the brain and spinal cord. Theoretically, fosaprepitant could interfere with nervous system recordings because of its effect on substance P,but it is not known if this actually occurs. The drug will be given after the patient has been anesthetized but before surgical incision so that if there are any changes on the intraoperative neuromonitoring signals they can only be attributed to fosaprepitant.
If fosaprepitant alters intraoperative neuromonitoring signals during surgical procedures under general anesthesia, it would be important because anesthesiologist's who administer this drug would want to give it at the beginning of surgery when changes in intraoperative neuromonitoring signals would be unlikely to mean that these changes were due to surgical damage to the nervous system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fosaprepitant | Other | Patients included in this study will be administered fosaprepitant 150 mg IV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fosaprepitant 150 mg | Drug | Antiemetic used to prevent nausea and vomiting after general anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Upper Extremity) | Neuromonitoring modality utilized during surgical procedures potentially affecting sensory component of central and peripheral nervous system. SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 4-channel EEG system at baseline (predose) and regularly after study drug administration. | Baseline (pre-dose) and 30, 60, and 90 minutes post-dose |
| Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Upper Extremity) | Neuromonitoring modality utilized during surgical procedures potentially affecting sensory component of central and peripheral nervous system. SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 4-channel EEG system at baseline (predose) and regularly after study drug administration. | Baseline (pre-dose) and 30, 60, and 90 minutes post-dose |
| Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Lower Extremity) | Neuromonitoring modality utilized during surgical procedures potentially affecting sensory component of central and peripheral nervous system. SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 4-channel EEG system at baseline (predose) and regularly after study drug administration. | Baseline (pre-dose) and 30, 60, and 90 minutes post-dose |
| Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Lower Extremity) | Neuromonitoring modality utilized during surgical procedures potentially affecting sensory component of central and peripheral nervous system. SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 4-channel EEG system at baseline (predose) and regularly after study drug administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Burbridge, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Palo Alto | California | 94305 | United States |
There is a plan to make IPD available only to members of the research team involved in this project. All patient identifying information will be removed from all data as it is collected to protect patient privacy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fosaprepitant | Patients receive fosaprepitant 150 mg intravenously (i.v.). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fosaprepitant | Patients receive fosaprepitant 150 mg intravenously (i.v.). |
| 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 | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Upper Extremity) | Neuromonitoring modality utilized during surgical procedures potentially affecting sensory component of central and peripheral nervous system. SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 4-channel EEG system at baseline (predose) and regularly after study drug administration. | Posted | Mean | Standard Deviation | µV | Baseline (pre-dose) and 30, 60, and 90 minutes post-dose |
|
Up to 6 hours
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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 | Fosaprepitant | Patients receive fosaprepitant 150 mg intravenously (i.v.). | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Burbridge | Stanford University | (650) 353-8484 | markburb@stanford.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 25, 2019 | Jun 2, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| C579707 | fosaprepitant |
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A single group of up to 50 patients will be administered a standard dose of fosaprepitant 150 mg IV after induction of anesthesia. A standard neuromonitoring setup utilizing motor evoked potentials, and somatosensory evoked potentials will be used as indicated for the type of surgery. After baseline neuromonitoring measurements have been made, but prior to surgery starting, we will administer the fosaprepitant to determine if there are any effects on the motor evoked potentials or somatosensory evoked potentials measurements.
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| Baseline (pre-dose) and 30, 60, and 90 minutes post-dose |
| Motor Evoked Potentials Amplitude (Left Upper Extremity) | Neuromonitoring modality utilized during surgical procedures affecting motor component of central and peripheral nervous system. MEPs are generated when stimulation of the brain on the motor cortex (with Transcranial Magnetic Stimulation [TMS]) causes the spinal cord and peripheral muscles to produce neuroelectrical signals. MEPs are typically measured in the hand muscles. | Baseline (pre-dose) and 30, 60, and 90 minutes post-dose |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Upper Extremity) | Neuromonitoring modality utilized during surgical procedures potentially affecting sensory component of central and peripheral nervous system. SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 4-channel EEG system at baseline (predose) and regularly after study drug administration. | Posted | Mean | Standard Deviation | µV | Baseline (pre-dose) and 30, 60, and 90 minutes post-dose |
|
|
|
|
| Primary | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Lower Extremity) | Neuromonitoring modality utilized during surgical procedures potentially affecting sensory component of central and peripheral nervous system. SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 4-channel EEG system at baseline (predose) and regularly after study drug administration. | Posted | Mean | Standard Deviation | µV | Baseline (pre-dose) and 30, 60, and 90 minutes post-dose |
|
|
|
|
| Primary | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Lower Extremity) | Neuromonitoring modality utilized during surgical procedures potentially affecting sensory component of central and peripheral nervous system. SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 4-channel EEG system at baseline (predose) and regularly after study drug administration. | Posted | Mean | Standard Deviation | µV | Baseline (pre-dose) and 30, 60, and 90 minutes post-dose |
|
|
|
|
| Primary | Motor Evoked Potentials Amplitude (Left Upper Extremity) | Neuromonitoring modality utilized during surgical procedures affecting motor component of central and peripheral nervous system. MEPs are generated when stimulation of the brain on the motor cortex (with Transcranial Magnetic Stimulation [TMS]) causes the spinal cord and peripheral muscles to produce neuroelectrical signals. MEPs are typically measured in the hand muscles. | Posted | Mean | Standard Deviation | µV | Baseline (pre-dose) and 30, 60, and 90 minutes post-dose |
|
|
|
|
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| Title | Measurements |
|---|---|
|
| 90 minutes |
|
| 0.72 |
| Other |
| Difference in right upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dose | t-test, 2 sided | 0.78 | Other |
| Title | Measurements |
|---|---|
|
| 90 minutes |
|
| 0.39 |
| Other |
| Difference in left lower extremity amplitude between baseline (pre-dose) and 90 minutes post-dose | t-test, 2 sided | 0.08 | Other |
| Title | Measurements |
|---|---|
|
| 90 minutes |
|
| 0.37 |
| Other |
| Difference in right lower extremity amplitude between baseline (pre-dose) and 90 minutes post-dose | t-test, 2 sided | 0.49 | Other |
| Title | Measurements |
|---|---|
|
| 90 minutes |
|
| 0.388 |
| Other |
| Difference in left upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dose | t-test, 2 sided | 0.247 | Other |