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

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ClinicalTrials.gov Identifier: NCT03197064
Recruitment Status : Not yet recruiting
First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Mark Burbridge, 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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea Drug: Fosaprepitant 150 mg Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Fosaprepitant on Motor Evoked and Somatosensory Evoked
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Fosaprepitant
Patients included in this study will be administered fosaprepitant 150 mg IV.
Drug: Fosaprepitant 150 mg
Antiemetic used to prevent nausea and vomiting after general anesthesia.




Primary Outcome Measures :
  1. Somatosensory evoked potentials [ Time Frame: 1 hour after drug administration ]
    Neuromonitoring modality utilized during surgical procedures affecting sensory component of central and peripheral nervous system

  2. Motor evoked potentials [ Time Frame: 1 hour after drug administration ]
    Neuromonitoring modality utilized during surgical procedures affecting motor component of central and peripheral nervous system



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197064


Contacts
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Contact: Mark A Burbridge, MD 650-353-8484 markburb@stanford.edu
Contact: Richard A Jaffe, MD, PhD (650) 723-6411 rajaffe@stanford.edu

Locations
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United States, California
Stanford University Medical Center Not yet recruiting
Palo Alto, California, United States, 94305
Contact: Mark A Burbridge, MD    650-353-8484    markburb@stanford.edu   
Contact: Richard A Jaffe, MD, PhD    (650) 723-6411    rajaffe@stanford.edu   
Principal Investigator: Mark A Burbridge, MD         
Sub-Investigator: Richard A Jaffe, MD, PhD         
Sub-Investigator: Jaime R Lopez, MD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Mark A Burbridge, MD Stanford University

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Responsible Party: Mark Burbridge, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03197064     History of Changes
Other Study ID Numbers: IRB-41444
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There is a plan to make IPD available only to members of the research team involved in this project. All patient identifying information will be removed from all data as it is collected to protect patient privacy.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Postoperative Nausea and Vomiting
Nausea
Vomiting
Postoperative Complications
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Fosaprepitant
Aprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action