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
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Nausea||Drug: Fosaprepitant 150 mg||Phase 4|
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.
|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)|
|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|
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.
- 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
- 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
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
|Contact: Mark A Burbridge, MDemail@example.com|
|Contact: Richard A Jaffe, MD, PhD||(650) firstname.lastname@example.org|
|United States, California|
|Stanford University Medical Center||Not yet recruiting|
|Palo Alto, California, United States, 94305|
|Contact: Mark A Burbridge, MD 650-353-8484 email@example.com|
|Contact: Richard A Jaffe, MD, PhD (650) 723-6411 firstname.lastname@example.org|
|Principal Investigator: Mark A Burbridge, MD|
|Sub-Investigator: Richard A Jaffe, MD, PhD|
|Sub-Investigator: Jaime R Lopez, MD|
|Principal Investigator:||Mark A Burbridge, MD||Stanford University|