Clinical trial NCT03297021
Conditions: Post-operative Nausea and Vomiting
Keywords: ambulatory surgery post-operative nausea and vomiting general anesthesia
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2017-10-23; Completion date: 2019-04-05
Enrollment: 141 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The aim is to evaluate the effectiveness of three different regimens of prophylactic ondansetron on the incidence and severity of post-operative nausea and vomiting.

Detailed description:
Patients will be randomize to one of three arms: 4mg ondansetron pre-emergence, 8 mg ondansetron pre-emergence, or 4mg ondansetron pre-incision followed by 4mg ondansetron pre-emergence. Primary outcome will be incidence of PONV in the PACU prior to discharge.

Arms: arm 1: None arm 2: None arm 3: 4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
Interventions: intervention 1: Ondansetron 4 MG intervention 2: Ondansetron 8mg
Intervention descriptions: intervention 1: dose as per arm selection intervention 2: dose as per arm selection

Protocol documents:
Prot_SAP_000.pdf: 
Effects of ondansetron dose and timing 
on rates of post-operative nausea and vomiting
PI: Dr. Daniel Katz 
NCT03297021 
Document Date: 9/14/2017


Icahn School of Medicine at Mount Sinai
Mount Sinai Beth Israel
Mount Sinai Brooklyn
The Mount Sinai Hospital
Mount Sinai Queens
New York Eye and Ear Infirmary
of Mount Sinai
Mount Sinai St. Luke's
Mount Sinai West
Program for the Protection
of Human Subjects
Institutional Review Boards
Mount Sinai Health System
One Gustave L. Levy Place, Box
 1081
New York, NY 10029-6574
T 212-824-8200
F 212-876-6789
irb@mssm.edu
icahn.mssm.edu/pphs
Initial Application
IRB-17-02095
Daniel Katz
Table of Contents
1. Summary - Title.....................................................................................................................................................................1
2. Summary - Setup..................................................................................................................................................................2
3. Summary - Background......................................................................................................................................................4
4. Research Personnel.............................................................................................................................................................6
5. Sites.......................................................................................................................................................................................... 7
6. Subjects - Enrollment.......................................................................................................................................................... 8
7. Subjects - Setting and Resources...................................................................................................................................9
8. Subjects - Populations......................................................................................................................................................10
9. Subjects - Participation.....................................................................................................................................................11
10. Subjects - Risk and Benefits........................................................................................................................................12
11. Procedures - Narrative...................................................................................................................................................14
12. Procedures - Genetic Testing......................................................................................................................................15
13. Procedures - Details....................................................................................................................................................... 16
14. Procedures - Compensation.........................................................................................................................................17
15. Consent - Obtaining Consent.......................................................................................................................................18
16. Consent - Documents.....................................................................................................................................................19
17. Data - Collection...............................................................................................................................................................20
18. Data - Storage.................................................................................................................................................................. 21
19. Data - Safety Monitoring................................................................................................................................................23
20. Financial Administration................................................................................................................................................. 24
21. Attachments....................................................................................................................................................................... 25


IRB-17-02095
Initial Application
Daniel Katz
1. Summary - Title
Protocol Title
Effects of ondansetron dose and timing
on rates of post-operative nausea and vomiting
Principal Investigator
Daniel Katz
When the application is complete, it will be sent to the PI for submission
When the application is complete, it will be sent to the PI for submission
Primary Department
Anesthesiology
When the application is complete, it will be sent to the PI for submission
Application Initiated By
David Maerz
Lay Summary
Post-operative nausea and vomiting represent a significant concern for perioperative and postoperative professionals
 as it can lead to increased morbidity among patients. In addition, it is being increasingly recognized as a primary
 source of patient discomfort and dissatisfaction, often exceeding complaints regarding pain. This has led to its
 adoption into a number of currently existing quality measures. 
Several medications and strategies currently exist with the aim of reducing the overall incidence of post-operative
 nausea and vomiting. We seek to compare three different regimens of the often used medication ondansetron
 in order to determine if there is a difference between these regimens and if an optimal one exists. We are using
 standard doses of ondansetron for this study and wish to examine the function of time as an additional component
 of the dosing. Prior studies have established the principals we are using, but none have taken the final task of
 comparing these regimens. 
IF Number
IF2092854
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IRB-17-02095
Initial Application
Daniel Katz
2. Summary - Setup
Funding Has Been Requested /
 Obtained
No
Application Type
Request to Rely on Mount Sinai IRB
Research Involves
Prospective Study ONLY
Consenting Participants
Yes
Requesting Waiver or Alteration
 of Informed Consent for Any
 Procedures
No
Humanitarian Use Device (HUD)
 Used Exclusively in the Course of
 Medical Practice
No
Use of an Investigational Device to
 Evaluate Its Safety or Effectiveness
No
Banking Specimens for Future
 Research
No
Cancer Related Research that
 Requires Approval from the
 Protocol Review and Monitoring
 Committee (PRMC).
No
   Is this Cancer Related Research?  Cancer Related Research is defined as research that
 has cancer endpoints or has a cancer population as part of or all of its targeted population.
 This includes protocols studying patients with cancer or those at risk for cancer.
  
Clinical Trial
Yes
   
   * A prospective biomedical or behavioral research study of human subjects that is
 designed to answer specific questions about biomedical or behavioral interventions
 (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). 
   *  Used to determine whether new biomedical or behavioral interventions are safe,
 efficacious, and effective.    
  
Drugs / Biologics 
No
   
   * Drugs / Biologics That Are Not a Part of Standard Practice 
   * Controlled Substances 
   * Drugs / Biologics Supplied by the Research Sponsor or Purchased with Study Funds 
  
   Ionizing Radiation for imaging or therapy, including X-Ray, Fluoroscopy, CT, Nuclear
 Medicine, PET andor Radiation Therapy:
  
* Purely for standard of care:
No
* In frequency or intensity that
 exceeds what is necessary for
 standard of care:
No
Hazardous Materials
No
   * Recombinant DNA 
   * Viral Vectors 


   * Plasmids 
   * Bacterial Artificial Chromosomes 
   * Toxic Chemicals, Potentially Toxic Medications, Carcinogens 
   * Autologous Cell Lines 
  
Request Use of Clinical Research
 Unit Resources
No
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IRB-17-02095
Initial Application
Daniel Katz
3. Summary - Background
Objectives
Determination of whether differing standard dosing regimens of ondansetron produce different levels of effect in
 regards to the incidence of early and late post-operative nausea and vomiting. 
Background
Post-operative nausea and vomiting (PONV) is a significant concern in all patients undergoing any form of anesthesia
 with a varied level of incidence from 20% to as high as 80% in some studies [1]. PONV is a significant cause of
 morbidity and dissatisfaction among patients, and begins to become a systems concern when it takes place in the
 ambulatory surgery environment. The Previous studies have indicated a high prevalence of ambulatory surgery
 in the United States, representing up to and in some studies exceeding 60% of all surgical procedures [1]. Post-
operative nausea and vomiting represents a significant cause of unanticipated requirement for hospital admission
 following ambulatory surgery, representing 7.4% of unanticipated admissions in one study [2]. Examination of
 potential costs relating to PONV demonstrated less spent on patients who received perioperative anti-emetics vs.
 those who did not receive prophylaxis (considering drug costs) [1]. 
Ondansetron has been well established medication for the prophylaxis of PONV for well over a decade across
 several patient populations [3,4]. Several studies have been performed to determine the difference between dose
 levels and regimens of ondansetron with varied results. However, certain consensuses seem to exist among studies
 with a dose of 4mg Ondansetron given nearing the end of the procedure before anesthesia finish time having
 a greater effect on PONV prophylaxis than a single dose given before or at the procedure start time [5,6,7]. A
 previous study conducted to compare a dose of 4mg Ondansetron at the beginning of the surgical case, compared
 to 4mg Ondansetron approaching surgical finish, to a divided dosing of 2mg Ondansetron in the beginning and 2mg
 Ondansetron at the end demonstrated that 4mg at the end was superior to the divided 2mg + 2mg dosing which was
 superior to the 4mg at the beginning [7]. Some studies have compared 8mg of Ondansetron at the end of surgery to
 4mg Ondansetron with varying results, some showing it as more effective and others failing to distribute a consistent
 improvement, no studies reported an increased incidence of side effects [8,9].
References
1. Hill R., et al. Cost-effectiveness of Prophylactic Antiemetic Therapy with Ondansetron, Droperidol, or Placebo.
 Anesthesiology. 2000;92:958-67. 
2. Linares-Gil, et al. Unanticipated admissions following ambulatory surgery. Ambulatory Surgery. 1989;5:183-8.
3. Gupta P, Jain S. Postoperative nausea and vomiting prophylaxis: a comparative study of ondansetron, granisetron,
 and granisetron and dexamethasone combination after modified radical mastectomy. Saudi Journal of Anaesthesia.
 2014;8:S67-71.
4. Ummenhofer W, et al. Effects of ondansetron in the prevention of postoperative nausea and vomiting in children.
 Anesthesiology.  1994;81:804-10.
5. Cruz N, Portilla P, Vela R. Timing of ondansetron administration to prevent postoperative nausea and vomiting. P
 R Health Science Journal. 2008;27:43-7.
6. Sun R, Klein K, White P. The Effect of Timing of Ondansetron Administration in Outpatients Undergoing
 Otolaryngologic Surgery. Anesthesia & Analgesia. 1997;84:331-6. 
7. Tang J, et al. The Effect of Timing of Ondansetron Administration on its Efficacy, Cost-Effectiveness, and Cost-
Benefit as a Prophylactic Antiemetic in the Ambulatory Setting. Anesthesia & Analgesia. 1998;86:274-282.
8. Paventi S, Santevecchi A, Ranieri R. Efficacy of a single-dose ondansetron for preventing post-operative nausea
 and vomiting after laparoscopoic cholecystectomy with sevoflurane and remifentanil infusion anaesthesia. Eur Rev
 Med Pharmacol Sci. 2001;5:59-63.
9. Honkavaara P. Effect of ondansetron on nausea and vomiting after middle ear surgery during general anaesthesia.
 British Journal of Anaesthesia. 1995;76:316-18.
Primary and Secondary Study Endpoints
Primary Endpoint: Cumulative incidence of reported post-operative nausea and vomiting
Secondary Endpoints: Early post-operative nausea (0-6 hours post-operative), early post-operative vomiting (0-6
 hours post-operative), late post-operative nausea (6-48 hours post-operative), late post-operative vomiting (6-48
 hours post-operative), type of surgery, duration of surgery, duration of anesthesia care, need for dosing of anti-
emetics following end of anesthesia time, need for "rescue" anti-emetics during anesthesia time


Protocol Was Already Approved
 by the Icahn School of Medicine at
 Mount Sinai (ISMMS) Institutional
 Review Board (IRB) Under a
 Different Principal Investigator
No
Protocol Was Previously Submitted
 to an External(non-ISMMS) IRB
No
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IRB-17-02095
Initial Application
Daniel Katz
4. Research Personnel
Name/Department
Role/Status
Contact
Access
Signature
 Authority
Phone
Email
Daniel Katz /
 Anesthesiology
PI / Faculty
SIGNAUTH
David Maerz /
 Anesthesiology
Co-Investigator / 
EDIT
Chang Park /
 Anesthesiology
Co-Investigator / 
EDIT
6464135254
Monique Pierre /
 Anesthesiology
Admin (non-FCOI) /
 Staff (non MD)
EDIT
212-241-7749
John Martins /
 Anesthesiology
Co-Investigator / 
READONLY
Dennis Wolf /
 Anesthesiology
Co-Investigator / 
READONLY
 
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IRB-17-02095
Initial Application
Daniel Katz
5. Sites
Site Name
Icahn School of Medicine at Mount Sinai
Other External Site Name
Contact Details
Approved
Approval Document
Funded By Mount Sinai
Other IRB
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IRB-17-02095
Initial Application
Daniel Katz
6. Subjects - Enrollment
Site Name
Icahn School of Medicine at Mount Sinai
Subjects To Be Enrolled
300
Total Number of Subjects to be
 Enrolled Across All Listed Sites
 Above (Auto Populated)
300
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IRB-17-02095
Initial Application
Daniel Katz
7. Subjects - Setting and Resources
Setting of Human Research
Other
Specify Other Setting of Human Research
5 East 98th St Ambulatory Surgery Center
Total Number of Subjects Needed
 To Complete Study
300
Feasibility of Meeting Recruitment Goals
Familiarity and experience working at the 5 East 98th st practice has yielded that at least 3-5 cases are done there on
 a daily basis making the recruitment goals feasible to meet within a period as short as 3-6 months.
Facilities To Be Used for Conducting Research
The operating rooms where the 5 East 98th st ambulatory surgery cases will be performed. 
Multi-Center Study
No
Community-Based Participant
 Research Study
No
  PI must attest to the following. 
   * Process is adequately described to ensure that all persons assisting with the trial are
 adequately informed about the protocol, the investigational product(s), and their trial-
related duties and functions.
     
    
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IRB-17-02095
Initial Application
Daniel Katz
8. Subjects - Populations
Inclusion Criteria
Any patient undergoing an ambulatory surgery case at 5 East 98th st regardless of level of anesthesia planned for
 administration (mild sedation to general anesthesia). 
Exclusion Criteria
Allergy or prior intolerance to dexamethasone, allergy or prior history of intolerance to ondansetron, concomitant
 use of apomorphine, and pregnant patients. In addition any patient with an officially diagnosed Long-QT syndrome.
 Patients currently on pre-operative steroids will also be excluded.
Enrollment Restrictions Based
 Upon Gender, Pregnancy,
 Childbearing Potential, or Race
Yes
Justify Restriction(s)
Ondansetron does not have FDA approval for use as an anti-emetic in pregnant patients.
Age Range(s)
18 to 64 Years, 65 Years and Over
Targeted Population(s)
Adults - Patients 
Other Aspects that Could Increase Subjects Vulnerability
The main aspect that could increase subject's vulnerability is anxiety on the day of the procedure. 
Safeguards to protect Subjects rights and welfare
Subjects will be assured that their decision to participate or decline to participate in the study will in no way affect the
 kind of anesthetic or surgical care that they receive. In addition, they will be assured that all arms of the study are
 aimed at prevention of post-operative nausea and vomiting, are each used by practitioners within the institution, and
 each represents modalities with aspects shown to be successful in attempts at post-operative nausea and vomiting
 prevention. 
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IRB-17-02095
Initial Application
Daniel Katz
9. Subjects - Participation
Duration of an Individual Subjects Participation in the Study
Day of surgery to end of 48 hour post-operative period. 
Duration Anticipated to Enroll All Study Subjects
All subjects are expected to be enrolled within a 9 month period. 
Estimated Date for the Investigators
 to Complete This Study
Within one year
Procedures for Subjects to Request Withdrawal
Subjects may withdraw from the study at any point leading up to initiation of surgical start time. Following the end of
 anesthetic care they may request to withdraw from the study which would result in their episodes of post-operative
 nausea and vomiting to not be recorded as data and for any data sheets relevant to them to be destroyed. They
 would still receive a standard post-operative phone call, but the nurses will be instructed to not explicitly record their
 responses on a study sheet. 
Procedures for Investigator to Withdraw Subjects
Investigators will withdraw subjects from the study if they are not able to receive the dictated medication dose (such
 as drug not available or practitioner neglected to administer) at which point their data sheet will be destroyed and
 disposed of in a secure patient confidential disposal bin present at the site. 
Participants Will Be Recruited
Yes
Recruitment Method(s)
Clinical Practice
How Participants Will Be Identified
Any patient undergoing a procedure at the 5 East 98th Street ambulatory surgical practice location who does not
 possess one of the exclusion criteria. The clinical anesthesiology team will do their initial assessment and screen for
 potential subjects. Once identified, the research team will then approach the patients.
Who Will Initially Approach
 Potential Participants
Treating Physician
How Research Will Be Introduced to Participants
Following the patient being consented and pre-operaticely examined by the Anesthesiologist and Surgeon as part of
 standard procedure, they will be re-approached by the Anesthesiologist and have the study described to them and
 given the opportunity to consent. 
Given that this surgical center performs cases for many many surgeons there is no way to inform subjects about the
 study prior to the day of the surgery. We have therefore designed an information sheet describing the study that will
 be sent to the surgeons for distribution to their patients.
How Participants Will Be Screened
Screening will be part of the pre-operative examination which should identify any of the exclusion criteria. 
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Initial Application
Daniel Katz
10. Subjects - Risk and Benefits
Risks to Subjects
The primary salient risk to subjects due to this study is the added anxiety on the day of their procedure. Other risks
 are those associated with the two study drugs dexamethasone and ondansetron. There is a risk of temporary
 headache associated with ondansetron usage that varies in studies from 0.1-9%. However, the doses of
 ondansetron being used are less than that described in the package insert in regards to side effects (12-16mg in
 package insert compared to 4-8mg in study).
Side effects of Dexamethasone when given as a one time dose of 4mg are very mild and transient. A small subset
 of patients may see a small rise in serum glucose concentration, however this has been shown in multiple studies
 to not be clinically significant, even in patients with diabetes. Although with higher and repeated doses of steroids
 there is also a risk of infection, a single small dose of dexamethasone does not increase the risk of an infectionas
 demonstrated in several studies. There is also a risk of allergy to any medication, however, steroids are often used to
 treat allergy and as such this risk is very low.
In addition, there is a risk of being involved in a study as it has the chance to provide a distraction to the individual
 administering medications as it may deviate from his/her typical behavior. 
However, the drug risks are not significantly increased as a result of this study as they are typically administered to all
 patients undergoing anesthetic care at Mount Sinai Hospital. The advent of CMS Merit Based Incentives Payments
 (MIPS) adoption by the hospital has resulted in >75% of patients already receiving this combination per standard
 care.
There is also the risk of loss of confidentiality.
Description of Procedures Taken to Lessen the Probability or Magnitude of Risks 
In order to lessen the magnitudes of risks we have designed a pragmatic protocol that mirrors the common behaviors
 in the department in terms of dosing time which also closely mirrors the literature. This should lessen any behavioral
 interference of the study. 
In terms of drug side effects, we are using a drug that is typically used for PONV prophylaxis and is used extensively
 within the department. Adding on to this we are using ondansetron dosing regimens that are well below the limits in
 the package insert and those associated with the side-effect of headache. 
In order to reduce stress to the participant, the individual consenting will emphasize no impact will occur relating to
 surgical or anesthetic care as a result of declining to participate, and that the study involves practices commonly
 used in the department. 
Provisions for Research Related Harm / Injury
Patients will have availability of care within the Mount Sinai Hospital relating to any anxiety or drug based harms that
 could occur. Beyond this the study does not present more than minimal risk.
Expected Direct Benefit to Subjects
The expected direct benefit is a reduced incidence of post-operative nausea and vomiting. All three arms of the study
 have been proven to be effective in reducing PONV and none of the three has been studied directly yet to prove
 definitive superiority to any of the other treatments used in this study.  
Benefit to Society
PONV represents a common reason for admission following ambulatory surgery, this reduction of PONV can result in
 less costs incurred by the hospital, insurance companies, and tax payers.
Provisions to Protect the Privacy Interests of Subjects
The subjects will only interact with members of their care team that they would have interacted with if this study did
 not exist. Their consent will be from their primary Anesthesiologist doing the case and their post-operative follow
 up once they go home will be done by the 5E98th street nurse who normally would be calling for follow up. This will
 prevent any additional impact on the patients relating to additional care team members.
There are no plans for additional follow up beyond the normal post-operative period. 
Economic Impact on Subjects
No economic cost is anticipated for subjects as this will not affect their anesthetic service billing. There is a possible
 economic benefit if they are able to avoid an unexpected hospital admission due to prevention of their PONV.


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IRB-17-02095
Initial Application
Daniel Katz
11. Procedures - Narrative
Description of the Study Design
Randomized controlled clinical trial.
Patients will be consented at the time of their anesthesia consent on the day of their procedure. If the patient
 consents they will be randomized to one of the three arms of the study, if they refuse they will receive standard pre,
 peri, and post-operative care. 
The first treatment arm consists of 4mg Dexamethasone given between anesthesia induction and procedure start
 time and a dose of 4mg Ondansetron given before procedure finish time with the aim of it being 30 minutes prior to
 anticipated procedure finish.
The second arm consists of 4mg Dexamethasone given between anesthesia induction and procedure start time along
 with a dose of 4mg Ondansetron given at the same time followed by an additional dose of 4mg Ondansetron given
 before procedure finish time with the aim of it being 30 minutes prior to anticipated procedure finish.
The third arm consists of 4mg Dexamethasone given between anesthesia induction and procedure start time and a
 dose of 8mg Ondansetron given before procedure finish time with the aim of it being 30 minutes prior to anticipated
 procedure finish.
The data recorded with be the patient's age and sex, the type of procedure performed, the duration of the procedure,
 the duration of anesthesia, the time of antiemetic dosing, and the dose of antiemetic given.
Following the anesthesia finish, the patient will be monitored in the recovery area per normal protocol and the
 patient's nurse will be instructed to record any incidents of vomiting and the patient will be queried regarding
 their nausea immediately upon arrival into the recovery area, one hour following arrival, and immediately prior to
 discharge. All responses will be recorded. 
Patients will then be contacted the next day per normal protocol, with the addition that the nurse will specifically ask
 about any episodes of nausea and vomiting in this period and will record them accordingly. 
Description of Procedures Being Performed
A dose of dexamethasone will be administered at the time of induction of anesthesia and before procedure start time.
 Depending on which arm the patient is randomized to they will either receive a dose of ondansetron at this time or
 will solely receive a dose of ondansetron before procedure finish. This will involve the injection of an IV medication
 through an already existing intravenous line. 
A data sheet will then be filled out post-operatively describing any episodes of nausea or vomiting as well as any
 additional anti-emetics given. The patients will be called as part of normal post-operative care and any episodes of
 nausea and vomiting disclosed will be recorded on the sheet. 
Description of the Source Records that Will Be Used to Collect Data About Subjects 
Source records will be the data sheet filled out during the time the patient is at 5 East 98th sheet and during their
 post-operative call.
Description of Data that Will Be Collected Including Long-Term Follow-Up
Data collected will be: the patient's age and sex, the type of procedure performed, the duration of the surgery, the
 duration of the anesthesia care, the anti-emetics administered perioperatively and postoperatively, any recorded
 episodes of nausea and vomiting in the post-operative period at 5 East 98th and upon the post-operative phone call. 
No follow up beyond the post-operative phone call period is planned. 
Research Requires HIV Testing
No
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IRB-17-02095
Initial Application
Daniel Katz
12. Procedures - Genetic Testing
Genetic Testing Will Be Performed
No
Guidance and Policies > Future Use Data Sharing and Genetic Research
  
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Initial Application
Daniel Katz
13. Procedures - Details
Surveys or Interviews
No
Audio / Photo / Video Recording
No
Deception
No
Results of the Study Will Be Shared
 with Subjects or Others
No
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Initial Application
Daniel Katz
14. Procedures - Compensation
Compensation for Participation
No
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IRB-17-02095
Initial Application
Daniel Katz
15. Consent - Obtaining Consent
Consent Process
Adult Consent
Where and When Consent Will Be Obtained
5 East 98th street ambulatory surgery practice
Waiting Period for Obtaining Consent
Waiting period will be the time between the study being described and prior to the patient being escorted for surgery.
 This typically is around 30 minutes but can vary to as long as 60 minutes.
SOP HRP-090 Informed Consent
 Process for Research Is Being
 Used
Yes
PPHS Worksheets, Checklists and SOPs
  
Process to Document Consent in
 Writing
Will Use Standard Template
Non-English Speaking Participants
 Will Be Enrolled
Yes
What Languages Other Than English Will Be Used
Spanish
What Process Will Be Used
Long Form
  
  The consent document must be translated into the language of the potential subject, and
 approved by the IRB, before you can go through the consent process with the non-English
 speaking person. If, after the project is approved, a short form consent process is needed,
 please see the PPHS policy and submit a modification.
     
 
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Daniel Katz
16. Consent - Documents
Consent Documents
Type
Oral Consent Script
Name
Oral Consent Script
Upload
PONV Oral Consent Script.docx
Type
Waiver Checklist
Name
Waiver Checklist
Upload
PONV HRP-416 - CHECKLIST - Waiver
 of Written Documentation of the Consent
 Process.docx
Consent Templates
  
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Initial Application
Daniel Katz
17. Data - Collection
Health Related Information Will Be
 Viewed, Recorded, or Generated
Yes
Description of Health Information That Will Be Viewed, Recorded, or Generated
Past medical history, surgical procedure, allergies, duration of surgery, duration of anesthesia, medications
 administered during visit, and results of post-operative contact. 
Non-Health Related Information Will
 Be Viewed or Recorded
Yes
Description of Non-Health Information That Will Be Viewed or Recorded
Patient's sex and age. 
HIV / AIDS Related Information Will
 Be Viewed or Recorded
No
Data That Will Be Viewed,
 Recorded, or Generated Contains
 ANY of the Following Directly
 Identifiable Information
No
  
  * Name 
  * Social Security Number 
  * Medical Record Number 
  * Address by Street Location 
  * Telephone Number 
  * Fax Number 
  * Web Uniform Resource Locators (URLs) 
  * Internet Protocol (IP) Address 
  * Health Plan Beneficiary Number 
  * Account Number 
  * Certificate 
  * License Number 
  * Vehicle Identification Number (Including License Plate Numbers) 
  * Full-Face Photographic Images 
  * Biometric Identifiers (Finger and Voice Prints) 
  * Geographical Subdivisions Smaller Than a State 
  * All Elements of Dates for Dates Directly Related to an Individual (i.e., Birth Date,
 Admission Date, Discharge Date) 
     * Email Address 
     
 
Data Collection Sheet
        
        A Data Collection Sheet is required if you are either performing a retrospective review,
 or your study meets the category of exempt 4 research, or your study meets the category
 of expedited 5 research. Please upload it here.
        
    
Data Collection Source(s)
Participant
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Daniel Katz
18. Data - Storage
Location Where Data Will Be Stored
Data will be stored on an encrypted drive on an encrypted server on a computer within the PIs office. The binder
 containing date sheets will also be kept in the PIs office in a locked cabinet behind a door accessible via a T9 code. 
How will the data be stored?
Anonymously
Research Personnel Responsible
 for:
Daniel Katz
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
Yes
Research Personnel Responsible
 for:
David Maerz
Accessing Data
Yes
Receipt or Transmission of Data
Holding Code That Can Be Linked
 to Identity of Participants
Research Personnel Responsible
 for:
Chang Park
Accessing Data
Yes
Receipt or Transmission of Data
Holding Code That Can Be Linked
 to Identity of Participants
Research Personnel Responsible
 for:
Monique Pierre
Accessing Data
Receipt or Transmission of Data
Holding Code That Can Be Linked
 to Identity of Participants
Research Personnel Responsible
 for:
John Martins
Accessing Data
Receipt or Transmission of Data
Holding Code That Can Be Linked
 to Identity of Participants
Research Personnel Responsible
 for:
Dennis Wolf
Accessing Data
Receipt or Transmission of Data
Holding Code That Can Be Linked
 to Identity of Participants
Duration Data Will Be Stored
Data will be stored up until study completion with publication. 
Steps That Will Be Taken to Secure the Data During Storage, Use, and Transmission
The binder with the data sheet will be kept in the co-investigator's office near the endoscopy suite that is kept locked
 at all times and can only be accessed through T-9 door code.  There will be no linking information or identifiers as
 part of the data sheet. Once the patient consents to the study a study number will be generated on their data sheet
 and the sheet will be removed from their record by the post-op phone call nurse and picked up by the research team.
 No linking information will be present between the data sheet and the patient.


Transmission of communications will only occur via secure sinai email means and usage will only occur on secure
 Mount Sinai computers on premise. 
Power Analysis/Data Analysis Plan (Including Any Statistical Procedures)
Data analysis will be performed by an in-house statisician associated with the Anesthesiology department. 
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Daniel Katz
19. Data - Safety Monitoring
More Than the Minimum Data
 Safety Monitoring Will Be Done
Yes
Principal Monitor
Daniel Katz
Additional Monitors
Specific Items That Will Be Monitored for Safety
The PI will review with the nursing team the post-operative assessment of the patients in the study to ensure that no
 harm has occurred. 
Frequency of Data Review
Every month the assessments will be reviewed. The data will be analyzed when half of the patients have been
 recruited to see if the study is necessary to continue
Rules for Alteration of Study Design
Should encounter an increase in side effects or should we find a significant difference prior to study completion we
 will stop recruiting. 
Selection Procedures to Minimize Toxicity
There are no such procedures for this medication. It is and has been well tolerated at these doses for many many
 years.
Grading System to Evaluate Adverse Events
We will use a system of yes/no for adverse events.
Any event that gets a yes will then be graded on a likert scale of 1-5, 1 is minor and 5 is major. 
Procedures to Assure Data Accuracy
All charts will be reviewed by the PI at the time of completion but before full anonymization to ensure data accuracy.
Suspension Reported to
the IRB
Anticipated Circumstances of Subject Withdrawal
None, this medication has been used for a long time at the doses we are administering it. We do not anticipate any
 issues with withdrawal of patients.
Primary or Secondary Safety Endpoints
Primary safety endpoint: general recovery profile of the patient as recorded by the nurses post operative assessment
Secondary safety endpoint: refractory nausea and vomiting
Data Monitoring Committee
 Description
DMC Description.docx
DMC Charter Available
No
Will the Research Include Data
 Coordinating Center Activities?
No
Page 23 of 25


IRB-17-02095
Initial Application
Daniel Katz
20. Financial Administration
  This information will help the Financial Administration of Clinical Trials Services (FACTS)
 office determine whether a Medicare Coverage Analysis (MCA) is needed for the research
 study. If you have any questions while completing this form, please contact the FACTS
 office at (212) 731-7067 or FACTS@mssm.edu.
  
 
Clinical Research Study Category
Investigator Initiated
  Payment Options: 
  * Option 1:  No protocol-required services will be billed to patients or third-party payers.
 Does Not Need MCA 
  * Option 2:  Protocol-required services (i.e., routine care services) will be billed to patients
 or third-party payers. Must Have MCA 
  * Option 3:  Study is initiated and federally funded by a Government Sponsored
 Cooperative Group who will only pay for services that are solely conducted for research
 purposes and other protocol-required services (i.e., routine care services) will be billed to
 patients or third-party payers. Billing Grid Only Required, NO MCA 
  * Option 4:  Study involves only data collection and has no protocol-required clinical
 services. Does Not Need MCA 
  * Option 5:  Study is not described in any of the above options. Please describe the study
 and specify whether External Sponsor (i.e., industry, government, or philanthropic source)
 and/or patient/third party payer will pay for protocol required services. MCA MAY Be
 Required 
  
 
Payment Option
Option 1
  
  No MCA is needed per option selected above. 
  
 
  
  Payment Option 1: 
  * Option 1A:  Department/collaborating departments will act as internal sponsor paying for
 all protocol-required services and no protocol-required services will be billed to patients or
 third party payers. 
  * Option 1B:  Study involves protocol-required clinical services and an External Sponsor
 (i.e., industry, government, or philanthropic source) will pay for all protocol-required
 services. 
  
 
Payment Option 1
Option 1A
Page 24 of 25


IRB-17-02095
Initial Application
Daniel Katz
21. Attachments
Type
Name
Version Status
Filename
Uploaded
 Date
Other - Other IRB
 Correspondance
Data Sheet
1
New
PONV Data
 Sheet.docx
06/29/2017
Data Monitoring
 Committee
 Description
DMC
 Description.docx
1
New
DMC
 Description.docx
08/07/2017
FDA - Package Insert
 for Approved Drug
Ondansetron
1
New
PackageInsertOndansetron.pdf
08/07/2017
Other - Other IRB
 Correspondance
IDEATE HRP-502a-
MSHS TEMPLATE
 CONSENT
 DOCUMENT-ADULT
 8.7.17.doc
1
New
Ideate HRP 502a-
MSHS TEMPLATE
 CONSENT
 DOCUMENT-
ADULT9.12.17.doc
09/12/2017
Other - Participant
 Educational
 Materials
Patient Information
 Sheet.docx
1
New
Patient Information
 Sheet.docx
08/07/2017
Consent - Consent
 Document
Clean Consent
 Version
1
New
Final Consent Clean
 Version 9.14.17.doc
09/14/2017
 
Page 25 of 25