Clinical trial NCT02643979
Conditions: Obesity Bariatrics Sleep Apnea Syndromes Gastric Bypass Endoscopy
Keywords: Ketamine Propofol Ketofol Obese Upper gastrointestinal endoscopy Sedation Bariatric
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2016-01-01; Completion date: 2019-01-05
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Propofol is one of the most popular anesthetic drugs used for sedation during upper gastrointestinal endoscopies due to its quick onset and quick resolution of symptoms allowing patients to leave the hospital sooner. However, when administered it can also slow the breathing of patients and cause others to have upper airway obstruction (such as snoring) which can impede proper spontaneous breathing. Ketamine is an agent that is capable of providing both pain control and sedation while having either minimal effect on breathing or promoting spontaneous breathing. Combining Ketamine with Propofol has the potential to reduce the total amount of Propofol used resulting in a procedure being performed under the same level of sedation but without the downside of reduced spontaneous breathing. Patients who are obese (defined as body mass index greater than 35) tend to be even more susceptible to this effect of Propofol. The researchers are investigating whether the addition of Ketamine will indeed allow for this continued comfortable level of sedation while promoting continued spontaneous breathing in obese patients undergoing upper gastrointestinal endoscopies.

Detailed description:
Upon patient arrival to endoscopy suite heart rate (HR), pre-procedure baseline blood pressure (BP), and pre-procedure oxygen saturation (SPO2) via pulse oximeter are recorded in endoscopy holding area, patient alertness and orientation assessed (respond to name, know the state, know the hospital, know the year, know the season).

Once the subject enters the endoscopy suite monitors are placed to record starting BP, HR, SPO2 recorded, nasal cannula with end tidal carbon dioxide (CO2) monitor attached, and 5-lead ECG.

Following time out patient given 100mg Lidocaine IV bolus, 1-minute delay, then study-provided syringe administered. Once patient assessed to produce an RSS score \>5 (Asleep with sluggish response to glabellar tap or NO response) endoscopy proceeds.

Recorder (blinded) notes if initially provided syringe alone was enough to produce an RSS \>5, notes subject's response to endoscopy insertion (presence or absence of gagging), notes amount of additional propofol required to maintain adequate conditions to continue endoscopy, records non-invasive blood pressure (NIBP) at 3-minute intervals, notes for level of airway obstruction (obstruction with continued air movement, obstruction requiring chin lift or jaw thrust for relief, obstruction requiring progression to assisted ventilation or intubation), notes for desaturation events (SPO2 \<90% with a coherent waveform).

At the end of the procedure the total anesthesia time is recorded, total procedure start-to-finish time recorded, total dose of propofol recorded, and any incidence of patient agitation noted.

Once in recovery the recovery room admission HR, SPO2, NIBP recorded followed by admission +15 minutes HR, SPO2, and NIBP, any incidence of desaturation (\<90% SPO2 with waveform) recorded, incidence of airway obstruction (with air movement, requiring airway maneuver, requiring intervention) recorded, time until patient is alert and oriented recorded (response to name, able to state what state they are in, able to state what hospital they are in, able to state the year, able to state the season), time-until-recovered recorded (Modified Aldrete Score \> 9), incidence of nausea prior to recovery recorded, incidence of vomiting prior to recovery recorded, incidence of agitation or delirium prior to recovery recorded.

Arms: arm 1: This arm receives a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy. arm 2: This arm receives 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
Interventions: intervention 1: Ketofol intervention 2: Propofol intervention 3: Saline
Intervention descriptions: intervention 1: 50mg of Ketamine mixed with 100mg of Propofol intervention 2: 100mg of Propofol intervention 3: 1mL of saline

Protocol documents:
Prot_000.pdf: 
Ketamine and Propofol Combination versus Propofol for Upper
Gastrointestinal Endoscopy
Dr. Daniel J. Katz
NCT02643979
Document Date: Aug 28, 2015


 
Protocol Name: 
Ketamine and Propofol Combination versus Propofol for Upper 
Gastrointestinal Endoscopy 
Principal Investigator:  
Daniel J Katz, MD 
Primary Contact 
Name/Contact Info: 
Daniel J Katz 
(212) 241-7473; Daniel.Katz@mountsinai.org 
Date Revised: 
08/28/2015 
Study Number: 
IF#: 1790780 
 
1 
Revised 9/2/14 
HRP-503 PROTOCOL TEMPLATE  
 
Note that, depending on the nature of your research, certain questions, directions, or entire sections below 
may not be applicable. Provide information if and when applicable, and in cases where an entire section is not 
applicable, indicate this by marking the section “N/A”.  Do not delete any sections. 
 
For any items below that are already described in the sponsor’s protocol, the investigator’s protocol,  the 
grant application, or other source documents, you may simply reference the title and page numbers of these 
documents in the sections below, rather than cutting and pasting into this document. Do not refer to the 
Sample Consent document, or information on the application form in this document.. 
 
Keep an electronic copy of this version of the document. You will need to modify this copy when making 
changes. 
 
Brief Summary of Research (250-400 words):  
Upper gastrointestinal endoscopies are commonly performed in patients planned to 
undergo bariatric surgery in order to detect and possibly treat lesions that could otherwise 
affect the surgery to be performed. Also, it can identify lesions that may complicate 
surgery or produce additional symptoms in the post-operative period. Obese patients 
present a challenge to the anesthesiologist due to their propensity for airway obstruction 
when exposed to agents commonly used for upper endoscopies including propofol, 
midazolam, and fentanyl. The increased incidence of obstructive sleep apnea (OSA) in this 
population further puts these patients at risk for obstruction in the peri-operative and post-
operative period. Ketamine is an agent that has a possibility to provide some benefit to this 
population through its ability to maintain spontaneous airway reflexes and have less of an 
effect on spontaneous ventilation as the aforementioned agents. Through the combination 
of ketamine with propofol we hope to decrease the incidence of airway obstruction in this 
population while still maintain an adequate depth of anesthesia to allow the 
gastroenterologist to carry out the upper endoscopy efficiently.  
1) Objectives 
Research Question:  Can ketamine combined with propofol create an adequate depth of 
anesthesia for an upper gastrointestinal endoscopy while decreasing the incidence of 
airway obstruction? 
The frequency of bariatric surgery is increasing, and the incidence of comorbidities, such 
as obstructive sleep apnea are being recognized more and more often in this patient 
population. This produces challenges for managing these patients safely in the 
perioperative and post-operative period. We hope to establish that a ketamine and propofol 
combination can produce adequate procedural conditions while decreasing the incidence of 
airway obstruction without a significant increase in time to discharge compared to the use 
of propofol as a sole agent.  


 
Protocol Name: 
Ketamine and Propofol Combination versus Propofol for Upper 
Gastrointestinal Endoscopy 
Principal Investigator:  
Daniel J Katz, MD 
Primary Contact 
Name/Contact Info: 
Daniel J Katz 
(212) 241-7473; Daniel.Katz@mountsinai.org 
Date Revised: 
08/28/2015 
Study Number: 
IF#: 1790780 
 
2 
Revised 9/2/14 
2) Background 
Provide the scientific or scholarly background for, rationale for, and significance of the 
Human Research based on the existing literature.  
Literature was reviewed regarding the use of ketamine for procedural sedation in the 
bronchoscopy and endoscopy suite as well as sedation for emergency department 
procedures. The combination of ketamine with other anesthetic agents has been shown to 
result in decreased dosage requirements of other agents, decreased incidence of airway 
obstruction requiring assistance, and mixed results regarding recovery time with some 
studies demonstrating quicker recovery including in obese patients and others 
demonstrating unchanged or prolonged recovery times with higher doses (2mg/kg) of 
ketamine. A large portion of the literature focuses on the use of ketamine in procedural 
sedation for emergency department (ED) procedures, especially in the pediatric population. 
Studies involving adults and endoscopy/bronchoscopy demonstrate overall positive results, 
however there is a dearth of literature involving the use of ketamine in the obese 
population.  
 
The benefits of ketamine compared to most other anesthetic agents lie in its ability to 
produce hypnosis and analgesia with minimal respiratory depression and in some cases 
stimulatory effects on respiratory drive. The population that would stand to benefit most 
from these attributes of the medication are those prone to airway obstruction such as 
overweight individuals. This is especially salient given the fact that individuals with a 
higher BMI may require higher doses of propofol, which causes significant respiratory 
depression and increased incidences of airway obstruction. 
 
As more patients turn to bariatric surgery as a method of weight loss when conservative 
measures fail, there is an increased need for upper endoscopies on this population prior to 
the surgery. High BMI patients present a unique challenge to the anesthesiologist due to an 
unfortunate coupling of increased medication dosage and a higher risk of airway 
obstruction and desaturation due to changes in body habitus. As mentioned previously, the 
benefits of ketamine could significantly benefit this population due not only to the 
attributes of this medication but its ability to decrease the overall propofol dosage required 
to tolerate upper endoscopy. 
Prior experiences in upper endoscopy in the bariatric population often involves the 
avoidance of adjuncts such as midazolam or fentanyl that can perpetuate the incidence of 
airway obstruction in the peri-operative and post-operative period in addition to causing 
delay in discharge from the PACU. These procedures result in higher dosing of propofol 
with increased incidence of hypotension along with increased incidence of apnea. 
Ketamine has been used on occasion to assist with anesthetic depth without increasing 
incidence of airway obstruction and respiratory depression, but the use is not regular 


 
Protocol Name: 
Ketamine and Propofol Combination versus Propofol for Upper 
Gastrointestinal Endoscopy 
Principal Investigator:  
Daniel J Katz, MD 
Primary Contact 
Name/Contact Info: 
Daniel J Katz 
(212) 241-7473; Daniel.Katz@mountsinai.org 
Date Revised: 
08/28/2015 
Study Number: 
IF#: 1790780 
 
3 
Revised 9/2/14 
enough to truly evaluate any benefit or harm that is modulated by the addition of ketamine 
to the anesthetic.  
There is no preliminary data. 
As the prevalence of obesity continues to increase in the United States, so does the 
incidence of comorbidities such as gastroesophageal reflux, hiatal hernia, and the 
occurrence of bariatric surgery. All of these situations often result in patients undergoing 
an upper endoscopy for diagnostic or therapeutic purposes. Selecting patients who are 
planned to undergo bariatric surgery will result in a snapshot of the high BMI population. 
Evaluating an induction technique that has the potential to provide protection of airway 
reflexes while providing adequate depth for endoscopy has the potential to provide 
additional information regarding an anesthetic technique that may be especially safe and 
beneficial to this patient population.  
Few anesthetic drugs are able to provide hypnotic and analgesic effects without significant 
depression of airway reflexes or spontaneous breathing. Ketamine is one of these rare 
agents and its use in the obese patient population, who are already more prone to airway 
obstruction and respiratory depression, could result in evidence for a safer anesthetic 
technique.  
 
References: 
Tandon, M., et al. Addition of sub-anesthetic dose of ketamine reduces gag reflex during 
propofol based sedation for upper gastrointestinal endoscopy: a prospective randomised 
double-blind study. Indian Journal of Anaesthesia (58). July 2014. 
Dal, T., et al. A comparison of ketamine-midazolam and ketamine-propofol combinations 
used for sedation in the endobronchial ultrasound-guided transbronchial needle 
aspiration: a prospective, single-blind, randomized study. Journal of Thoracic Disease. 
2014;6(6):742-751. 
Street, M., and Gerard, J. A Fixed-Dose Ketamine Protocol for Adolescent Sedation in a 
Pediatric Emergency Department. The Journal of Pediatrics. 2014 (165) 453-458.  
Newton A., and Fitton, L. Intravenous ketamine for adult procedural sedation in the 
emergency department: a prospective cohort. Emergency Medicine Journal. 2008(25);498-
501.  
Sih, K, et al. Ketamine in Adult Emergency Medicine: Controversies and Recent Advances. 
The Annals of Pharmacotherapy. 2011(45);1525-1534. 
Pambianco, D. Future Directions in Endoscopic Sedation. Gastrointestinal Endoscopy 
Clinicians of North America. 2008(18);789-799.  
 


 
Protocol Name: 
Ketamine and Propofol Combination versus Propofol for Upper 
Gastrointestinal Endoscopy 
Principal Investigator:  
Daniel J Katz, MD 
Primary Contact 
Name/Contact Info: 
Daniel J Katz 
(212) 241-7473; Daniel.Katz@mountsinai.org 
Date Revised: 
08/28/2015 
Study Number: 
IF#: 1790780 
 
4 
Revised 9/2/14 
 
3) Setting of the Human Research 
This will be conducted at the Icahn School of Medicine in Manhattan with recruitment 
done in the endoscopy waiting area to our target patient population of Dr. Brijen Shah’s 
bariatric surgery patients.  
4) Resources Available to Conduct the Human Research 
Staff is composed of four clinicians, Daniel Katz, MD., Brijen Shah, MD., Jonathan Ko, 
MD., and David Maerz, MD. Dr. Katz is currently involved in a number of projects at 
Mount Sinai, and is extremely familiar with the population and protocols of Mount Sinai 
having gone to medical school, residency, and is now currently an attending here in the 
Department of Anesthesiology. Dr. Jonathan Ko is heavily involved in anesthetic delivery 
in endoscopy on a daily basis and is well versed in the endoscopy environment and the 
various populations that receive services here. Dr. Brijen Shah is heavily involved in upper 
endoscopies on patients planning to undergo bariatric surgery and will be involved in the 
selection and exclusion process of patients as well as the main proceduralist. Dr. David 
Maerz is a currently resident at Mount Sinai and is familiar with the endoscopy department 
and the care of bariatric patients and will be heavily involved in data collection.  
The four clinicians involved in patient selection, protocol creation, and carrying out the 
study are all in constant communication throughout the process. The endoscopy center 
performs these procedures on a daily basis, many of whom would be candidates for our 
study. We aim to recruit 100 patients, and predict we can reach this goal within 6 months 
based on prior schedules. 
 
5) Study Design 
 
a) Recruitment Methods 
Primarily recruitment of subjects will be through Dr. Brijen Shah’s practice involving 
patients receive an upper endoscopy prior to bariatric surgery. 
Recruitment materials will primarily consist of a verbal explanation of the procedure to be 
performed, how it is normally carried out from the anesthetic perspective, and our 
primarily goal of adding ketamine to the induction agent.  
b) Inclusion and Exclusion Criteria 
Eligible patient population will consist of Dr. Brijen Shah’s patient population who are 
undergoing an upper GI endoscopy prior to consideration for bariatric surgery. 


 
Protocol Name: 
Ketamine and Propofol Combination versus Propofol for Upper 
Gastrointestinal Endoscopy 
Principal Investigator:  
Daniel J Katz, MD 
Primary Contact 
Name/Contact Info: 
Daniel J Katz 
(212) 241-7473; Daniel.Katz@mountsinai.org 
Date Revised: 
08/28/2015 
Study Number: 
IF#: 1790780 
 
5 
Revised 9/2/14 
Exclusion criteria consist of: History of schizophrenia/schizoaffective disorder/bipolar 
disorder/dementia, glaucoma, craniofacial abnormalities, epilepsy, allergy to study drugs 
(propofol or ketamine), or history of current intracranial mass lesion. 
c) Number of Subjects 
A preliminary power analysis predicted we need 30 patients per group (total 90) to have 
significance using a Wilcox Rank Sum Test assuming skewed data. We therefore intend to 
enroll 100 patients to account or potential subjects who may not be appropriate for 
inclusion in statistical analysis after data collection. 
d) Study Timelines 
Each individual subject will be followed until discharge from the PACU when the patient 
has made both the clinical endpoints as well as standard discharge criteria. We anticipate to  
enroll all patients within one year. We estimate that the study will be completed six months 
after the enrollment of all subjects. 
e) Endpoints 
 
Primary endpoint is the incidence of gagging on endoscope insertion. 
Secondary endpoints consist of: mean arterial pressure and heart rate during procedure, 
dosage required to achieve conditions necessary to proceed with upper endoscopy, total 
dosage of medication used, incidence of peri-procedure or post-operative nausea and 
vomiting, incidence of airway obstruction necessitating airway maneuvering (chin lift, jaw 
thrust, etc.), incidence of emergence delirium, and time required until eligible for discharge 
from endoscopy post-anesthesia care unit (PACU). 
Since repeat ketamine doses will not be administered there are no specific primary or 
secondary endpoint parameters that would result in an end of study. In the event that 
unsafe vital signs changes or reaction to endoscopy occurred, the procedure would be 
aborted as would be standard protocol at our institution. 
f) Procedures Involved in the Human Research 
The study design is a prospective clinical study regarding the use of a 1:2 
Ketamine:Propofol mixture (50mg Ketamine to 100mg Propofol) for induction in the study 
arm compared to a sole 100mg Propofol induction technique. Following this all follow up 
boluses will consist of only propofol in both arms. Subjects will be evaluated for response 
to initial insertion of endoscope, need for follow up doses, changes in vital signs, incidence 
of airway obstruction, incidence of emergence delirium, and time to discharge from the 
PACU. No further follow up or evaluation is planned.  


 
Protocol Name: 
Ketamine and Propofol Combination versus Propofol for Upper 
Gastrointestinal Endoscopy 
Principal Investigator:  
Daniel J Katz, MD 
Primary Contact 
Name/Contact Info: 
Daniel J Katz 
(212) 241-7473; Daniel.Katz@mountsinai.org 
Date Revised: 
08/28/2015 
Study Number: 
IF#: 1790780 
 
6 
Revised 9/2/14 
The primary study protocol procedure is the administration of a ketamine vs. propofol and 
ketamine mixture with induction of anesthesia. The remainder of monitoring for safety and 
risk management are part of the normal anesthetic care all patients receiving upper 
endoscopy and evaluation prior to PACU discharge receive. Standard anesthetic monitors 
and vital sign monitoring will only differ in study patients in the use of a pre-determined 3-
minute non-invasive blood pressure monitoring interval instead of the minimum 5-minute 
interval advised by the ASA.  
Exclusion criteria is almost entirely based on comorbidities and conditions that have an 
association with an untoward reaction or intolerance to ketamine. In addition, the blood 
pressure monitoring intervals of 3 minutes are more frequent than the standard 
recommendation of 5 minutes, which allows providers to be more aware of any blood 
pressure changes as a result of the ketamine administration. In addition, upper endoscopy 
will not proceed until patient demonstrates an adequate Ramsay sedation scale score of >5 
to reduce incidence of patient discomfort or recall.  
Source records will include the patients chart for the specific endoscopy encounter in epic 
which will be used for demographic information and to monitor the patient’s length of stay 
and any events that occurred in the endoscopy PACU. Compurecord will be used to collect 
data regarding medication administration, vital signs, and any intraoperative events 
including toleration of upper endoscopy and incidence of airway obstruction. 
No data will be collected in the form of long-term follow up.  
g) Specimen Banking 
N/A 
h) Data Management and Confidentiality 
 
Data will be collected on paper that will indicate the patient’s medical record and her study 
number assignment, and her initials. There will be no indication on these sheets of the patient’s 
name.  The data collection sheet is attached. The data on the sheets will be transferred to an Excel 
computerized spreadsheet without the patient’s initials.  The excel data base is in a computer with 
a password.  Also, the excel program is protected by a password.  Data will also be encrypted for 
confidentiality. We will have a separate binder that will have the patients name along with their 
medical record # should we need to recheck records for any reason.  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.  The binder with the identifying information will 
be kept in the principal investigator’s office, also a locked office via T9 code that is in a different 
building.  Only the PI will have access to these records. 
 
i) Provisions to Monitor the Data to Ensure the Safety of Subjects 
There is no anticipation of more than minimal risk involved to subjects.  


 
Protocol Name: 
Ketamine and Propofol Combination versus Propofol for Upper 
Gastrointestinal Endoscopy 
Principal Investigator:  
Daniel J Katz, MD 
Primary Contact 
Name/Contact Info: 
Daniel J Katz 
(212) 241-7473; Daniel.Katz@mountsinai.org 
Date Revised: 
08/28/2015 
Study Number: 
IF#: 1790780 
 
7 
Revised 9/2/14 
j) Withdrawal of Subjects 
The primary circumstance for which a subject would be withdrawn without their consent 
would result in vital signs on initial exam that are otherwise incompatible with proceeding 
with upper endoscopy, such as unexpected poor saturation on room air (SO2 <92%), vital 
signs and symptoms compatible with hypertensive urgency or emergency, or previously 
undiagnosed arrhythmia on EKG with associated clinical findings. Decisions based on 
these findings will vary with the anesthesia provider involved but could include 
withdrawal from study protocol and proceeding with upper endoscopy, or cancellation of 
upper endoscopy entirely with planned rescheduling once patient undergoes further 
workup.  
6) Risks to Subjects 
Reasonable risks include mild side effects from ketamine administration including 
hallucinations, dissociative sensation, or untoward sensory phenomenon, all of which can 
occur with propofol as well. This can result in prolonged PACU stay due to treatment. 
Studies in other areas using ketamine have shown a decreased incidence of these side 
effects when giving low doses such as ours for single administration. 
7) Provisions for Research Related Harm/Injury 
 
Every patient is followed intra and post operatively and assessed for complications and treated 
appropriately. The study patients will be treated the same in this regard. 
 
8) Potential Benefits to Subjects 
There is no expected long-term benefit from participation in the study. 
9) Provisions to Protect the Privacy Interests of Subjects 
 
No long-term follow up or post-operative phone contact beyond a normal post-operative 
check is planned for study participants. No personal information beyond what is required 
by a standard anesthesia pre-operative assessment will be collected and this information 
will be kept private by the same means it always is. Patient interviews will be conducted in 
individual private bays in the holding area as they always are unless otherwise indicated by 
the patient (wish to have partner present etc). Only patient initials will be used on the data 
collection sheet. This data will be stored in a locked cabinet and later on a password 
protected Mount Sinai computer. Only the PI will have access to the patient’s identifiable 
information. Patients will be reassured that all their information will remain confidential 
and private. 
10) 
Economic Impact on Subjects 
No planned economic impact. 


 
Protocol Name: 
Ketamine and Propofol Combination versus Propofol for Upper 
Gastrointestinal Endoscopy 
Principal Investigator:  
Daniel J Katz, MD 
Primary Contact 
Name/Contact Info: 
Daniel J Katz 
(212) 241-7473; Daniel.Katz@mountsinai.org 
Date Revised: 
08/28/2015 
Study Number: 
IF#: 1790780 
 
8 
Revised 9/2/14 
 
11) 
Payments to Subjects 
N/A 
12) 
Consent Process 
Consent will be obtained in the endoscopy waiting area prior to the patient being brought 
to the operating room. This will take place during the anesthesiologist’s pre-operative 
examination. If the subject desires they will have a waiting period of whatever length suits 
them in order to consult friends, family, their primary care physician, their 
gastroenterologist, or any other personnel or individuals they wish to speak with.  
The application personnel involved in the consent process will be Dr. Brijen Shah and a 
member of the anesthesiology team of either Drs. Katz, Ko, or Maerz. An average of 5-10 
minutes will be required to discuss the study and its ramifications on the patient with 
additional time as required for follow up questions or requests. 
Undue influence or coercion will be minimized by assuring patients that they will undergo 
their upper GI endoscopy regardless of their decision to participate in the study or not. In 
addition, this will occur after the typical pre-operative exam and anesthetic consenting 
process to avoid individuals believing their pre-operative exam or anesthetic consent could 
be unduly influenced by their response to the study consent.  
In order to assure the understanding of potential subjects, they will be asked to explain in 
their own words their interpretation of the purpose of the study, how it will be carried out, 
and any potential risks explained to them regarding the study. No additional tools or aids 
are planned as part of the consent process. 
Consent for the study prior to arrival in the suite is NOT feasible as the patients are 
referred to Dr. Shah from a multitude of surgeons. Dr. Shah does not see these patients in 
the office prior, nor do they come for pre-anesthesia testing. As such, consent prior to day 
of procedure is not possible. 
 
Children  
 
N/A 
Cognitively Impaired Adults 
N/A 
Non-English Speaking Subjects 


 
Protocol Name: 
Ketamine and Propofol Combination versus Propofol for Upper 
Gastrointestinal Endoscopy 
Principal Investigator:  
Daniel J Katz, MD 
Primary Contact 
Name/Contact Info: 
Daniel J Katz 
(212) 241-7473; Daniel.Katz@mountsinai.org 
Date Revised: 
08/28/2015 
Study Number: 
IF#: 1790780 
 
9 
Revised 9/2/14 
Non-English speaking subjects will be excluded from the study selection process. The 
primary reason for doing so involves the secondary endpoint of the incidence of post-
operative delirium. The inability to speak and understand influence fluently has the 
potential to introduce a significant confounder regarding a patient’s orientation to person, 
place, and time if a licensed interpreter is not readily available for a study participant.  
Waiver or Alteration of the Consent Process 
N/A 
 
13) 
Process to Document Consent in Writing 
Standard PPHS consent template to be used. 
14) 
Vulnerable Populations 
 
Include 
Exclude 
Vulnerable Population Type 
 
X 
Adults unable to consent 
 
X 
Individuals who are not yet adults (e.g. infants, children, teenagers) 
 
X 
Wards of the State (e.g. foster children) 
 
X 
Pregnant women 
 
X 
Prisoners 
 
15) 
Multi-Site Human Research (Coordinating Center) 
N/A 
16) 
Community-Based Participatory Research 
N/A 
17) 
Sharing of Results with Subjects 
No results will be shared. 
18) 
External IRB Review History 
This has not been previously submitted to an IRB, 
19) 
Control of Drugs, Biologics, or Devices 
 


 
Protocol Name: 
Ketamine and Propofol Combination versus Propofol for Upper 
Gastrointestinal Endoscopy 
Principal Investigator:  
Daniel J Katz, MD 
Primary Contact 
Name/Contact Info: 
Daniel J Katz 
(212) 241-7473; Daniel.Katz@mountsinai.org 
Date Revised: 
08/28/2015 
Study Number: 
IF#: 1790780 
 
10 
Revised 9/2/14 
Ketamine and Propofol vials will be procured following standard department protocol as part of a 
drug kit taken out from the operating room pharmacy by one of the study personnel (Drs. Katz, 
Ko, or Maerz). The Ketamine and Propofol or simply Propofol syringe will be prepared and 
provided from one of the aforementioned personnel’s drug kit and given to the practitioner caring 
for the study patient. As per department protocol this will be documented with the patient’s name 
and MRN on the study personnel’s drug sheet for that kit. In order to preserve blinding of the 
practitioner providing care, the induction agent will be added to compurecord at the conclusion of 
the case by the study personnel involved in the drug syringe preparation.  
 
Regarding the remainder of controlled substance handling, it will be done according to department 
policy which is listed below: 
 
I. Dispensing Controlled Substances 
A. OR 
1. To procure controlled substances, the anesthesia personnel obtains a Controlled Substance  
Administration Record from the pharmacy and the pharmacist will fill in the appropriate 
information: 
Date 
Operating room or cluster scheduled 
Printed name of requesting anesthesia personnel 
2. A kit of controlled substances will be dispensed to the anesthesia personnel. The kit will be 
labeled with the anesthesia personnel’s name, the drug content of the kit, and the issue number 
of the Controlled Substance Administration Record. 
 
3. The drug kit must remain with the anesthesia providercand cannot be left unattended at any 
time. 
 
4. The anesthesia personnel signs for drugs on the Controlled Substance Administration 
Record. 
 
5. The Controlled Substance Administration Record will be retained by the anesthesia 
personnel for documentation of the day’s cases. 
 
6. No preexisting drug kit will be supplemented with additional drugs without the pharmacy 
slip issued with the original drug kit. If an attending wishes to supplement a resident’s drug 
pack, they may do so only if they present the pharmacy drug slip to the pharmacist.  
II. Documentation 
A. Controlled Substance Administration Record 
1) For each case, the anesthesia personnel will fill in the required information on the 
Controlled Substance Admin istration Record, including: 
Patient name 


 
Protocol Name: 
Ketamine and Propofol Combination versus Propofol for Upper 
Gastrointestinal Endoscopy 
Principal Investigator:  
Daniel J Katz, MD 
Primary Contact 
Name/Contact Info: 
Daniel J Katz 
(212) 241-7473; Daniel.Katz@mountsinai.org 
Date Revised: 
08/28/2015 
Study Number: 
IF#: 1790780 
 
11 
Revised 9/2/14 
Number of ampules/tubexes of each drug administered 
Signature of the administering anesthesia personnel 
2) Full doses not administered must be returned to the Pharmacy. Partial doses 
remaining after parenteral administrationmay not be discarded, but must be returned. 
 
3) In the event an ampule/tubex is broken, the record of breakage should be noted on 
the Controlled Substance Administration Record and co-signed by a witnessing 
physician, R.N. or pharmacist. 
 
4) Each ampule or vial of a controlled substance can only be used for an individual 
patient, and the waste returned (see “return of Drugs” below)  
III. Return of Drugs 
A. OR 
1. The anesthesia personnel must return all unused drugs to the pharmacy before 7:00 
PM along with the Controlled Substance Administration Record.  
 
2. The anesthesia personnel reconciles any discrepancies and signs daily dispersing log. 
Amt. Returned = Amt. Issued –c(Amt. Administered + Amt. Wasted + Amt. Broken) 
 
3. All drugs including unused propofol, etomidate, remifentanil and ketamine, must be 
accounted for, documented and returned to the pharmacy with the proper patient 
information.  
 
4. Narcotic bags obtained from discontinued PCA’s or epidural infusions must be 
accounted for, documented and returned to the pharmacy with the proper patient 
information.  
 
5. No drawn up drug is to be wasted, i.e., squirted out, and must be accounted for, 
documented and returned to the pharmacy, including unused propofol, etomidate, 
ketamine, thiopental, fentanyl, midazolam etc.  
 
6. No one is to exchange an intact vial of medication for a drug previously drawn up I
 
nto a syringe. 
 
7. When the anesthesia care team is relieved by another team, any unused, controlled 
medications in syringes, must be returned to the pharmacy by the original anesthesia 
care giver and must not be turned over to the new anesthesia care team to be given later 
in the case.  
 


 
Protocol Name: 
Ketamine and Propofol Combination versus Propofol for Upper 
Gastrointestinal Endoscopy 
Principal Investigator:  
Daniel J Katz, MD 
Primary Contact 
Name/Contact Info: 
Daniel J Katz 
(212) 241-7473; Daniel.Katz@mountsinai.org 
Date Revised: 
08/28/2015 
Study Number: 
IF#: 1790780 
 
12 
Revised 9/2/14 
8. Anesthesia personnel on-call and those whose cases extend beyond 7:00 PM return 
unused drugs and the Controlled Substance Administration Record to a locked 
repository box outside the pharmacy. 
 
9. Any discrepancy is reconciled by the anesthesia personnel the following morning 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

SAP_001.pdf: 
 
Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy 
Data Analysis Plan 
PI: Dr. Daniel Katz 
NCT02643979 
Document Date: 12/20/2015 
 
 


 
Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy 
NCT02643979 
12/20/2015 
 
Statistical Plan and Analysis: 
All variables will be checked for normality via Shaprio Wilk Test. Our primary endpoint, since it 
is categorical in nature will be analyzed via chi square test. Each other categorical variable will 
be analyzed via chi square testing as well. For normally distributed variables, t-test will be used. 
For non-normally distributed variables non parametric tests such as Mann-Whitney-U and 
Wilcoxon Rank Sum will be used. Significance testing will all be two tailed, with a cutoff of 0.05 
as the threshold for statistical significance.