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NCT Number: NCT03197064

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

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University Medical Center

Palo Alto, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fosaprepitant 150 mg

Drug

Antiemetic used to prevent nausea and vomiting after general anesthesia.

Primary outcomes

  1. Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Upper Extremity)

    Time frame: 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.

  2. Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Upper Extremity)

    Time frame: 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.

  3. Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Lower Extremity)

    Time frame: 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.

  4. Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Lower Extremity)

    Time frame: 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.

  5. Motor Evoked Potentials Amplitude (Left Upper Extremity)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 23, 2017
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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