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

NCT03197064 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB-41444
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Fosaprepitant

OTHER

Patients included in this study will be administered fosaprepitant 150 mg IV.

Drug: Fosaprepitant 150 mg

Interventions

Fosaprepitant 150 mg DRUG

Antiemetic used to prevent nausea and vomiting after general anesthesia.

Fosaprepitant

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient refusal, allergy to the drug or any of its excipients, pre-operative motor or sensory deficit

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Medical Center

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

fosaprepitant

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Results Point of Contact

• Title: Dr. Mark Burbridge
• Organization: Stanford University

markburb@stanford.edu

(650) 353-8484

Study Officials

• Mark A Burbridge, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 23, 2017
• Study Start: January 1, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: July 18, 2022
• Results First Posted: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)