A Phase 4 interventional study of Fosaprepitant 150 mg in Postoperative Nausea, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-07-18.
Sponsored by Stanford University · Phase 4, Interventional, and Treatment
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.
629 studies on the registry are indexed under Postoperative Nausea and Vomiting; 113 are open to participants now.
This study's enrollment of 11 is below the median of 111 across 525 interventional studies indexed under Postoperative Nausea and Vomiting.
Browse Postoperative Nausea and Vomiting studies →Stanford University is the lead sponsor of 2,161 studies on the registry; 428 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 207 (77%) have results posted.
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Exclusion Criteria:
Patients included in this study will be administered fosaprepitant 150 mg IV.
Drug: Fosaprepitant 150 mg
Antiemetic used to prevent nausea and vomiting after general anesthesia.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
| Milestone | Fosaprepitant |
|---|---|
| Started | 11 |
| Completed | 11 |
| Not completed | 0 |
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.
| µV | Fosaprepitant |
|---|---|
| Baseline | 2.685 ± 1.49 |
| 30 minutes | 2.545 ± 1.15 |
| 60 minutes | 2.58 ± 1.29 |
| 90 minutes | 2.292 ± 1.02 |
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.
| µV | Fosaprepitant |
|---|---|
| Baseline | 2.38 ± 1.35 |
| 30 minutes | 2.47 ± 1.05 |
| 60 minutes | 2.27 ± 1.01 |
| 90 minutes | 2.47 ± 1.2 |
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.
| µV | Fosaprepitant |
|---|---|
| Baseline | 1.56 ± 0.854 |
| 30 minutes | 1.56 ± 0.831 |
| 60 minutes | 1.47 ± 0.67 |
| 90 minutes | 1.35 ± 0.693 |
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.
| µV | Fosaprepitant |
|---|---|
| Baseline | 1.7 ± 0.911 |
| 30 minutes | 1.77 ± 1.09 |
| 60 minutes | 1.81 ± 1.08 |
| 90 minutes | 1.79 ± 1.18 |
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.
| µV | Fosaprepitant |
|---|---|
| Baseline | 1300 ± 1128.48 |
| 30 minutes | 1573.33 ± 1508.37 |
| 60 minutes | 1634.89 ± 1460.48 |
| 90 minutes | 1544.78 ± 1579.12 |
Collected over Up to 6 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fosaprepitant | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | Fosaprepitant |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Fosaprepitant |
|---|---|
| Female | 6 |
| Male | 5 |
| Race and Ethnicity Not Collected(Participants) | Fosaprepitant |
|---|
| Region of Enrollment(participants) | Fosaprepitant |
|---|---|
| United States | 11 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Ran from Jan 2018 to primary completion in Jan 2020, 24 months.
Results were first posted in Jul 2022, 2 years 5 months after primary completion. A results delay was requested in Feb 2021.
Of 68 non-industry phase 4 interventional studies under Postoperative Nausea and Vomiting, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 24 months is above that.
Counting every sponsor, half of 68 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fosaprepitant
Postoperative Nausea and Vomiting →