Postoperative Nausea
Conditions
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.
Interventions
Antiemetic used to prevent nausea and vomiting after general anesthesia.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Upper Extremity) | Baseline (pre-dose) and 30, 60, and 90 minutes post-dose | 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) | Baseline (pre-dose) and 30, 60, and 90 minutes post-dose | 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) | Baseline (pre-dose) and 30, 60, and 90 minutes post-dose | 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) | Baseline (pre-dose) and 30, 60, and 90 minutes post-dose | 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) | Baseline (pre-dose) and 30, 60, and 90 minutes post-dose | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fosaprepitant Patients receive fosaprepitant 150 mg intravenously (i.v.). | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Fosaprepitant | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 11 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 11 participants | — |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
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.
Time frame: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fosaprepitant | Motor Evoked Potentials Amplitude (Left Upper Extremity) | Baseline | 1300 µV | Standard Deviation 1128.48 |
| Fosaprepitant | Motor Evoked Potentials Amplitude (Left Upper Extremity) | 30 minutes | 1573.33 µV | Standard Deviation 1508.37 |
| Fosaprepitant | Motor Evoked Potentials Amplitude (Left Upper Extremity) | 60 minutes | 1634.89 µV | Standard Deviation 1460.48 |
| Fosaprepitant | Motor Evoked Potentials Amplitude (Left Upper Extremity) | 90 minutes | 1544.78 µV | Standard Deviation 1579.12 |
Comparison: Difference in left upper extremity amplitude between baseline (pre-dose) and 30 minutes post-dosep-value: 0.386t-test, 2 sided
Comparison: Difference in left upper extremity amplitude between baseline (pre-dose) and 60 minutes post-dosep-value: 0.388t-test, 2 sided
Comparison: Difference in left upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dosep-value: 0.247t-test, 2 sided
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.
Time frame: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fosaprepitant | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Lower Extremity) | Baseline | 1.56 µV | Standard Deviation 0.854 |
| Fosaprepitant | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Lower Extremity) | 90 minutes | 1.35 µV | Standard Deviation 0.693 |
| Fosaprepitant | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Lower Extremity) | 30 minutes | 1.56 µV | Standard Deviation 0.831 |
| Fosaprepitant | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Lower Extremity) | 60 minutes | 1.47 µV | Standard Deviation 0.67 |
Comparison: Difference in left lower extremity amplitude between baseline (pre-dose) and 30 minutes post-dosep-value: 0.93t-test, 2 sided
Comparison: Difference in left lower extremity amplitude between baseline (pre-dose) and 60 minutes post-dosep-value: 0.39t-test, 2 sided
Comparison: Difference in left lower extremity amplitude between baseline (pre-dose) and 90 minutes post-dosep-value: 0.08t-test, 2 sided
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.
Time frame: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fosaprepitant | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Upper Extremity) | Baseline | 2.685 µV | Standard Deviation 1.49 |
| Fosaprepitant | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Upper Extremity) | 30 minutes | 2.545 µV | Standard Deviation 1.15 |
| Fosaprepitant | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Upper Extremity) | 60 minutes | 2.58 µV | Standard Deviation 1.29 |
| Fosaprepitant | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Upper Extremity) | 90 minutes | 2.292 µV | Standard Deviation 1.02 |
Comparison: Difference in left upper extremity amplitude between baseline (pre-dose) and 30 minutes post-dosep-value: 0.35t-test, 2 sided
Comparison: Difference in left upper extremity amplitude between baseline (pre-dose) and 60 minutes post-dosep-value: 0.47t-test, 2 sided
Comparison: Difference in left upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dosep-value: 0.066t-test, 2 sided
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.
Time frame: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fosaprepitant | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Lower Extremity) | 90 minutes | 1.79 µV | Standard Deviation 1.18 |
| Fosaprepitant | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Lower Extremity) | Baseline | 1.7 µV | Standard Deviation 0.911 |
| Fosaprepitant | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Lower Extremity) | 30 minutes | 1.77 µV | Standard Deviation 1.09 |
| Fosaprepitant | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Lower Extremity) | 60 minutes | 1.81 µV | Standard Deviation 1.08 |
Comparison: Difference in right lower extremity amplitude between baseline (pre-dose) and 30 minutes post-dosep-value: 0.42t-test, 2 sided
Comparison: Difference in right lower extremity amplitude between baseline (pre-dose) and 60 minutes post-dosep-value: 0.37t-test, 2 sided
Comparison: Difference in right lower extremity amplitude between baseline (pre-dose) and 90 minutes post-dosep-value: 0.49t-test, 2 sided
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.
Time frame: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fosaprepitant | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Upper Extremity) | Baseline | 2.38 µV | Standard Deviation 1.35 |
| Fosaprepitant | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Upper Extremity) | 30 minutes | 2.47 µV | Standard Deviation 1.05 |
| Fosaprepitant | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Upper Extremity) | 60 minutes | 2.27 µV | Standard Deviation 1.01 |
| Fosaprepitant | Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Upper Extremity) | 90 minutes | 2.47 µV | Standard Deviation 1.2 |
Comparison: Difference in right upper extremity amplitude between baseline (pre-dose) and 30 minutes post-dosep-value: 0.72t-test, 2 sided
Comparison: Difference in right upper extremity amplitude between baseline (pre-dose) and 60 minutes post-dosep-value: 0.72t-test, 2 sided
Comparison: Difference in right upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dosep-value: 0.78t-test, 2 sided