Effect of Fosaprepitant on Motor Evoked and Somatosensory Evoked Potentials Under General Anesthesia
Primary Purpose
Postoperative Nausea
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fosaprepitant 150 mg
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Nausea
Eligibility Criteria
Inclusion Criteria:
- Having a surgical procedure requiring general anesthesia, having a surgical procedure where neuromonitoing with somatosensory evoked potentials and motor evoked potentials neuromonitoring is requested by the surgical team
Exclusion Criteria:
- Patient refusal, allergy to the drug or any of its excipients, pre-operative motor or sensory deficit
Sites / Locations
- Stanford University Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Fosaprepitant
Arm Description
Patients included in this study will be administered fosaprepitant 150 mg IV.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03197064
Brief Title
Effect of Fosaprepitant on Motor Evoked and Somatosensory Evoked Potentials Under General Anesthesia
Official Title
Effect of Fosaprepitant on Motor Evoked and Somatosensory Evoked Potentials Under General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fosaprepitant
Arm Type
Other
Arm Description
Patients included in this study will be administered fosaprepitant 150 mg IV.
Intervention Type
Drug
Intervention Name(s)
Fosaprepitant 150 mg
Intervention Description
Antiemetic used to prevent nausea and vomiting after general anesthesia.
Primary Outcome Measure Information:
Title
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Upper Extremity)
Description
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.
Time Frame
Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
Title
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Upper Extremity)
Description
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.
Time Frame
Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
Title
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Lower Extremity)
Description
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.
Time Frame
Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
Title
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Lower Extremity)
Description
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.
Time Frame
Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
Title
Motor Evoked Potentials Amplitude (Left Upper Extremity)
Description
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.
Time Frame
Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having a surgical procedure requiring general anesthesia, having a surgical procedure where neuromonitoing with somatosensory evoked potentials and motor evoked potentials neuromonitoring is requested by the surgical team
Exclusion Criteria:
Patient refusal, allergy to the drug or any of its excipients, pre-operative motor or sensory deficit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Burbridge, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Learn more about this trial
Effect of Fosaprepitant on Motor Evoked and Somatosensory Evoked Potentials Under General Anesthesia
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