Effect of Fosaprepitant on Motor Evoked and Somatosensory Evoked Potentials Under General Anesthesia

Phase 4

Completed

Conditions: Postoperative Nausea

Interventions: Drug: Fosaprepitant 150 mg

Registration Number: NCT03197064

Lead Sponsor: Stanford University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 11

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fosaprepitant	Fosaprepitant 150 mg	Patients included in this study will be administered fosaprepitant 150 mg IV.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.