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

Postoperative Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197064
• Other study ID #: IRB-41444
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: July 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Nausea
• Postoperative Nausea and Vomiting

Intervention

Drug:
• Fosaprepitant 150 mg
Antiemetic used to prevent nausea and vomiting after general anesthesia.

Locations

Country	Name	City	State
United States	Stanford University Medical Center	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
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.	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.	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.	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.	Baseline (pre-dose) and 30, 60, and 90 minutes post-dose