Clinical trial NCT03197064
Conditions: Postoperative Nausea
Sponsor: Stanford University
Start date: 2018-01-01; Completion date: 2020-01-31
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

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.

Arms: arm 1: Patients included in this study will be administered fosaprepitant 150 mg IV.
Interventions: intervention 1: Fosaprepitant 150 mg
Intervention descriptions: intervention 1: Antiemetic used to prevent nausea and vomiting after general anesthesia.

Protocol documents:
Prot_000.pdf: 
 
Effect of Fosaprepitant on Motor Evoked and Somatosensory 
Evoked Potentials Under General Anesthesia 
NCT03197064 
June 25, 2019 
Mark Burbridge, Principal Investigator 
Stanford University 
Stanford, California 94305 
1. 
PURPOSE OF THE STUDY 
a. 
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. 
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. 
b. 
Objectives 
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. 
c. 
Rationale for Research in Humans 
We are specifically interested in evaluating if fosaprepitant alters intraoperative 
neuromonitoring signals in human patients having surgery under general anesthesia. 
2. 
STUDY PROCEDURES 
a. 
Procedures 
On the day of surgery the patient will be consented in the preoperative area. We regularly 
use fosaprepitant in surgical patients undergoing procedures under general anesthesia 
with intraoperative neuromonitoring. 


June 25, 2019 
 
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The patient will receive a single dose of 150 mg intravenous fosaprepitant after general 
anesthesia has been induced as prepared by pharmacy. Intraoperative neuromonitoring 
signals will be monitored for any changes during and after the administration of 
fosaprepitant. 
 
The patient's intraoperative anesthetic management will be that typically utilized for 
surgical procedures with intraoperative neuromonitoring. 
b. 
Procedure Risks 
Using fosaprepitant in the operating room is widely used in the United States and is 
generally considered safe. This study will no withhold medication used to treat post-
operative nausea and vomiting, rather, it seeks to determine if utilizing this very safe and 
effective medication during surgical procedures under general anesthesia with 
intraoperative neuromonitoring will alter or change intraoperative neuromonitoring 
signals due to the mechanism of action of the drug. 
c. 
Use of Deception in the Study 
No deception will be used. 
d. 
Use of Audio and Video Recordings 
No audio or video will be recorded. 
e. 
Alternative Procedures or Courses of Treatment 
At this point the use of fosaprepitant during surgery is at the discretion of the 
anesthesiologist. The effect of this medication on intraoperative neuromonitoring signals 
in patients having surgery under general anesthesia is not understood. No standard 
treatment is being withheld. 
f. 
Will it be possible to continue the more (most) appropriate therapy for the 
participant(s) after the conclusion of the study? 
After surgery the primary surgery team is free to utilize any nausea and vomiting control 
scheme they would like to use. 
g. 
Study Endpoint(s) 
Our study endpoint is whether a single dose of fosaprepitant at the start of surgery in 
patients having surgery under general anesthesia with intraoperative neuromonitoring 
causes any change in intraoperative neuromonitoring signals, and to quantify any such 
changes. 
3. 
BACKGROUND  
a. 
Past Experimental and/or Clinical Findings 
Fosaprepitant is a very effective medication used to prevent post- operative nausea and 
vomiting in patients having surgery under general anesthesia. The mechanism of action 


June 25, 2019 
 
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of this medication is through substance P inhibition, which has effects on numerous 
sensory systems in the brain and spinal column. In patients who have surgery under 
general anesthesia with intraoperative neuromonitoring, the sensory and motor pathways 
are monitored throughout the surgical procedure. It is not known if fosaprepitant could 
interfere with these intraoperative neuromonitoring signals due to its effect on sensory 
pathways via substance P inhibition. 
b. 
Findings from Past Animal Experiments 
No relevant animal literature exists. 
4. 
RADIOISOTOPES OR RADIATION MACHINES 
N/A 
5. 
DEVICES USED IN THE STUDY 
N/A 
6. 
DRUGS, BIOLOGICS, REAGENTS, OR CHEMICALS USED IN THE STUDY 
a. 
Investigational Drugs, Biologics, Reagents, or Chemicals 
N/A 
b. 
Commercial Drugs, Biologics, Reagents, or Chemicals 
Commercial Product 1 
Name: 
Fosaprepitant 
Dosage: 
150 mg 
Administration Route 
Intravenous (i.v.) 
New and different use? (Y/N) 
No 
7. 
DISINFECTION PROCEDURES FOR MEDICAL EQUIPMENT USED ON BOTH HUMANS AND 
ANIMALS 
N/A 
 
8. 
PARTICIPANT POPULATION 
a. 
Planned Enrollment 
The total number of participants expected to enroll is 50. 
 
Patients presenting for surgery under general anesthesia with intraoperative 
neuromonitoring will be approached to participant in this study. 
 
All participants will be at Stanford University Medical Center. 
 
We selected this patient population because we are particularly interested in knowing 
what effects, if any, fosaprepitant has on intraoperative neuromonitoring signals in 
patients having surgery under general anesthesia. 


June 25, 2019 
 
Page 4 of 7 
b. 
Age, Gender, and Ethnic Background 
There are no exclusions or preferences based on age, gender, or ethnic background. 
c. 
Vulnerable Populations 
We are not specifically seeking out any potentially vulnerable populations. 
d. 
Rationale for Exclusion of Certain Populations 
No children will be enrolled because this study will be carried out at Stanford University 
Medical Center which only manages adult patients. 
e. 
Stanford Populations 
Enrollment of laboratory personnel, employees, and/or students would be purely 
coincidental. No payment will be provided for participation. 
f. 
Healthy Volunteers 
No healthy volunteers will be enrolled in this study. Only patients coming to Stanford 
University Medical Center for surgery requiring general anesthesia and intraoperative 
neuromonitoring will be approached to participate. 
g. 
Recruitment Details 
Patients coming to Stanford University Medical Center for surgery requiring general 
anesthesia and intraoperative neuromonitoring will be approached to participate. 
h. 
Eligibility Criteria 
i. 
Inclusion Criteria 
Patients presenting to Stanford University Medical Center for surgery requiring 
general anesthesia with intraoperative neuromonitoring will be approached to 
participate. 
ii. 
Exclusion Criteria 
Exclusion criteria include patient refusal or inability to consent to this study, or a 
contraindication to receiving fosaprepitant. 
i. 
Screening Procedures 
Medical chart reviewed by the anesthesiologists involved in the study. 
j. 
Participation in Multiple Protocols 
Patients will be asked about participation in other studies. Enrollment in other studies that 
don't interfere with this study is acceptable. Surgical patients are frequently asked by the 
surgeon to allow the collection of tissue samples for research purposes. This is done 
during surgery and does not in any way interfere with this study. 


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k. 
Payments to Participants 
Subjects will not receive payment. 
l. 
Costs to Participants 
None. This medication available on the Stanford University Medical Center operating 
rooms formulary. It can be used at the discretion of the anesthesiologist managing the 
case. 
m. 
Planned Duration of the Study 
One year. The total time requirement for each participant is minimal. It includes the time 
to get informed consent. 
9. 
RISKS 
a. 
Potential Risks 
i. 
Investigational devices 
N/A 
ii. 
Investigational drugs 
N/A 
iii. 
Commercially available drugs, biologics, reagents or chemicals 
Most common adverse reactions (≥2%) are: fatigue, diarrhea, neutropenia, asthenia, 
anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, pain in 
extremity. 
iv. 
Procedures 
No procedures will be performed. 
v. 
Radioisotopes/radiation-producing machines 
N/A 
vi. 
Physical well-being 
No impact. 
vii. 
Psychological well-being 
No impact. 
viii. 
Economic well-being 
No impact. 
ix. 
Social well-being 
<Enter text or No impact. "NA"> 


June 25, 2019 
 
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x. 
Overall evaluation of risk 
Low risk. 
b. 
International Research Risk Procedures 
N/A 
c. 
Procedures to Minimize Risk 
Patients will be screened for history of allergy or hypersensitivity to fosaprepitant. 
d. 
Study Conclusion 
Study will terminate when either 50 participants have been enrolled, or when results are 
deemed significant enough by principle investigator. 
e. 
Data Safety Monitoring Plan (DSMC) 
i. 
Data and/or events subject to review 
According to section B1 of the data and safety monitoring form, we don't believe a 
DSMP is required for this study since it carries minimal risk. 
ii. 
Person(s) responsible for Data and Safety Monitoring 
Protocol Director 
iii. 
Frequency of DSMB meetings 
N/A 
iv. 
Specific triggers or stopping rules 
N/A 
v. 
DSMB Reporting 
N/A 
vi. 
Will the Protocol Director be the only monitoring entity? (Y/N) 
Yes 
vii. 
Will a board, committee, or safety monitor be responsible for study monitoring? 
(Y/N) 
No 
f. 
Risks to Special Populations 
N/A 
10. 
BENEFITS 
This study seeks to determine if fosaprepitant alters intraoperative neuromonitoring signals 
during general anesthesia. If it is found that this medication does alter intraoperative 


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neuromonitoring signals, it would be helpful to avoid administration of this medication during 
parts of the surgical procedure where changes in the intraoperative neuromonitoring signals could 
be mistakenly attributed to the surgical procedure causing neurological damage. 
11. 
PRIVACY AND CONFIDENTIALITY 
All participant information and specimens are handled in compliance with the Health Insurance 
Portability and Accountability Act (HIPAA) and privacy policies of Stanford University, Stanford 
Health Care, and Stanford Children’s Health.