Clinical trial NCT02604940
Conditions: Pain
Keywords: Postoperative narcotic requirements Dexmedetomidine Bariatric Surgery
Sponsor: West Virginia University
Start date: 2014-08-01; Completion date: 2018-06-25
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether a single bolus dose of dexmedetomidine administered during bariatric surgery has any effect on the amount of narcotic pain medications required by an individual after surgery. Patients who undergo weight loss surgery will be randomized into two groups - group one -dexmedetomidine group and group two- control group. Both groups will receive a standard anesthetic. Control group will receive weight based dose of fentanyl (standard narcotic pain reliever), intravenous acetaminophen (non-narcotic pain reliever), and 60ml saline. Experimental group will receive weight based dose of fentanyl (standard narcotic pain reliever), intravenous acetaminophen (non-narcotic pain reliever), and dexmedetomidine (given as 1mcg/kg over 10 minutes Intravenous). The Patient will then awaken after surgery in post anesthetic recovery unit and be given a patient controlled analgesia (PCA) pump with hydromorphone (long acting narcotic pain reliever). The amount of hydromorphone used will be recorded by the PACU nurse to the electronic health record ( routine practice) in the two groups and compared for pain medicine requirements. Secondary endpoints will be Visual Analog Score (VAS) pain score, respiratory rate, heart rate, blood pressure oxygen saturation and respiratory rate. All will be recorded at 30,60,90,120 and 240 minutes in the electronic medical record in PACU and compared between the two groups . All the data - Intra operative and Post -operative - Post Anesthesia Care Unit ( PACU) data will be retrieved from the electronic Medical record (EMR). All intra-operative data is automatically computed into the patients EMR. All PACU data is routinely entered into the EMR by the PACU nurse including the PCA data.

Detailed description:
This study will evaluate the postoperative opioid sparing effects of dexmedetomidine given as single bolus dose intraoperatively. Dexmedetomidine is an agonist of α2-adrenergic receptors sedative medication used by intensive care units and anesthesiologists and is unique in its ability to provide sedation without causing respiratory depression. Recently, it has received attention for its potential for additive analgesia. The study population will be patients undergoing gastric bypass surgery. The study population of bariatric surgery patients was chosen due to high prevalence of sleep apnea and Pickwickian component that can be worsened with opioid analgesia in the postoperative period. The purpose of the study is to test whether the use of a single bolus dose dexmedetomidine in addition to standard dose pain regimen decreases postoperative narcotic requirements when compared to standard dose pain regimen alone. The secondary purpose is to study whether single bolus dose dexmedetomidine reduces respiratory rate, heart rate, systolic and mean blood pressure, patient PCA demand bolus requests and VAS pain scores in the postoperative period. The overall goal of the study is to establish evidence of dexmedetomidine's role in multimodal pain relief in the bariatric surgery population with the possibility of other patient subgroups to follow

Arms: arm 1: Experimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure arm 2: Control group will receive Normal saline over 15 minutes at the beginning of surgical closure
Interventions: intervention 1: Dexmedetomidine intervention 2: Normal Saline
Intervention descriptions: intervention 1: 1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure intervention 2: 60ml Saline delivered over 10 minutes in OR upon notification of surgical closure.

Protocol documents:
Prot_SAP_000.pdf: 
Does Single Intraoperative Bolus Dexmedetomidine Significantly Reduce 
Narcotic Requirements During Postoperative Period in Bariatric Patients? 
NCT02604940 
April 09, 2014 
 
Protocol 
 
 


West Virginia University IRB Protocol #1306055796 
Does Single Intraoperative Bolus Dexmedetomidine Significantly Reduce 
Narcotic Requirements During Postoperative Period in Bariatric Patients? 
Contact Information:  
Pavithra Ranganathan  
 
 
 
Michael Kyle Ritchie 
Assistant Professor 
 
 
 
 
PGY-3, CA-2 Resident 
WVU Dept. of Anesthesiology 
 
 
 
WVU Dept. of Anesthesiology 
ranganathanp@wvuhealthcare.com 
 
 
ritchiem@wvuhealthcare.com 
Introduction: This study will evaluate the postoperative opioid sparing effects of dexmedetomidine 
given as single bolus dose intraoperativley.  Dexmedtomidine is an agonist of α2-adrenergic receptors 
sedative medication used by intensive care units and anesthesiologists and is unique in its ability to 
provide sedation without causing respiratory depression.  Recently, it has received attention for its 
potential for additive analgesia.   The study population will be patients undergoing gastric bypass 
surgery.  The study population of bariatric surgery patients was chosen due to high prevalence of sleep 
apnea and Pickwickian component that can be worsened with opioid analgesia in the postoperative 
period.  The purpose of the study is to test whether the use of a single bolus dose dexmedetomidine in 
addition to standard dose pain regimen decreases postoperative narcotic requirements when compared 
to standard dose pain regimen alone.  The secondary purpose is to study whether single bolus dose 
dexmedetomidine reduces respiratory rate, heart rate, systolic and mean blood pressure, patient PCA 
demand bolus requests and VAS pain scores in the postoperative period.  Our overall goal of the study is 
to establish evidence of dexmedetomidine's role in multimodal pain relief in the bariatric surgery 
population with the possibility of other patient subgroups to follow.  
Primary Objective:   The primary objective of the study is to assess if the use of a single bolus dose 
dexmedetomidine in addition to standard pain regimen given intraoperatively decreases postoperative 
narcotic requirements when compared to standard pain regimen alone. 
Secondary Objective:   The secondary objective of the study is to assess if the use of single bolus dose 
dexmedetomidine decreases respiratory rate, heart rate, systolic and mean blood pressure, patient PCA 
demand bolus requests and VAS pain scores in the postoperative period. 
Potential Benefits to Subjects 
a. Increased patient satisfaction and comfort 
b. Decreased narcotic requirements 
c. Decreased narcotic related side effects including nausea, constipation and respiratory 
depression 
d. Decreased stress response 
e. Reduced postoperative blood pressure  and heart rate 


f. 
Patient anxiolysis    
Study Design:  After informed consent is obtained in the Bariatric Surgery Center, patients will be 
enrolled in the study and assigned a code for the remainder of study.  The code will used by 
pharmacy for block randomization.  The code will be associated with MRN for patient identification 
and data entry by Co-investigators after patient has been discharged from study.  On the day of the 
procedure, preoperative nursing will place sticker on front of patient hard chart clearly marking 
participation in trial.  The control group will receive 1-2 mcg/kg fentanyl IV plus 1000 mg IV tylenol 
as well 60mL saline delivered over 15 minutes in OR upon notification of surgical closure.  The 
experimental group will receive 1-2 mcg/kg fentanyl IV plus 1000mg IV acetaminophen and 1mcg/kg 
IV dexmedetomidine deliver over 10 minutes from 60 mL syringe upon notification of surgical 
closure. Pharmacy will be notified of patient enrollment in trial, use block randomization sheet for 
assignment to treatment or control group, and prepare medication syringes.  Syringes will be 
delivered to OR for administration by anesthesia personnel upon notification of surgical closure.  
The investigators, patient, anesthesia staff, PACU nursing OR staff and surgeon will be blinded to 
medication being administered.  Pharmacy will not be blinded to medication as they will have block 
randomization sheet and assign patient by MRN to a given code. Time interval to extubation from 
procedure stop will be recorded in EMR by anesthesia personnel.  Upon arrival to PACU, patient will 
immediately receive hydromorphone and be instructed on its usage by PACU nursing.  PACU nursing 
will record HR, RR, BP, and VAS score q15min per PACU routine into EMR.  PCA will be interrogated 
at 30 minute, 1 hour, 90 minute, 2 hour and 4 hour mark by PACU nursing and usage in milligrams 
will be recorded in chart as nursing note for later review by researchers.  Included in PCA data will 
be total mg of hydromorphone used, number of demand doses given by pump, and number of times 
patient pushes demand button.  Patient will be discharged from study after 4 hour mark per OSA 
guidelines.  Results will be recorded into Redcap online statistics program to ensure data safety.  
Code and MRN block randomization sheet will be kept under lock and key in pharmacy. 
 
Patient Risk Management:  
a. Identification of Risk:  Because medication is to be given in this study, more than minimal risk 
will be incurred by the patient.  Participation is completely voluntary.  Risks include possible 
allergy or other unanticipated reaction to dexmedetomidine or hydromorphone.  Specific side 
effects to dexmedetomidine include symptomatic bradycardia, sinus arrest, hypertension, 
hypotension, and excessive sedation. Specific side effects related to hydromorphone are 
common to all narcotics and include sedation, respiratory depression, upper airway obstruction, 
constipation, illeus, bradycardia, nausea, and vomiting.   
 
b. Management of Risk:  :   During study period, syringes will be covered with opaque label as to 
blind surgeon and anesthesia personnel to contents.  Label can be peeled off at any time by 
anesthesia personnel to reveal syringe content in the event of an emergency and medication 
identification would be necessary for patient safety.  Patient would be disqualified from trial if 
this were to occur.  Atropine and glycopyrolate will be in syringes and ready for use as part of 
standard emergency drug regimen in case of hypotension or bradycardia experienced by patient 
throughout study period.  Dexmedetomidine or saline will not be administered to patient if 
systolic blood pressure is less the 90mmHg, mean arterial pressure less than 60, or if heart rate 
less than 50 bpm.  Rescue hydromorphone will be available in form of IV hydromorphone 2mg 
PRN q5mins if PCA dosing fails to control pain.  Patient will be disqualified from study if rescue 
medication was given. Medications will only be administered by trained anesthesia personnel.  


Trained PACU nurses under guidance of staff anesthesiologist will oversee PCA usage.  Trained 
pharmacy staff will prepare all medications for use.  Emergency resuscitation equipment and 
drugs including atropine and narcan will be immediately available at all.  
 
c. Confidentiality:  The records of this study will be kept confidential. The investigators will not 
include the name of any patient involved in the research.  Patients will be assigned a code 
number upon enrollment in study.  Code numbers will be used for block randomization in 
pharmacy to randomly assign patient to treatment groups.  Pharmacy staff will have access to 
patient chart and MRN for purpose of recording which drug was given, control or experimental.  
Block randomization sheet containing MRN and code numbers for patient will be kept under 
lock in key by pharmacy personnel.  The sheet will be kept for official study documentation.  A 
document listing the code associated with a specific patient and their MRN will be stored in 
redcap only to be viewed by the co-investigators for data analysis. The patient’s code number 
will be used on all other documentation to protect patient privacy. The investigators and 
statistician will be the only person who will have access to this data.   
 
d. Patient Data Safety Plan:  Researchers will access the code sheet at 25, 50, 75, and 100 patient 
enrolment points to record pertinent clinical data for analysis.  Included in the interval analysis 
will be medical futility and critical detrimental patient events to assure patient safety 
throughout trial.  Times.  Specifically, study personnel will look for instances of symptomatic 
bradycardia or other heart rhythm disturbances, oversedation, respiratory failure, hypotension 
or other unforeseen critical event.  Patients will be provided with study personnel contact 
information in case adverse event possibly related to study were to occur after discharge from 
study All data will be entered and safely stored in redcap, an online secured server maintained 
by School of Public Health 
 
Number of Subjects: 100 subjects (50 subjects assigned to control group and 50 to treatment group) 
a. Subject Characteristics:  The participants in the study will include 100 bariatric surgery patients 
at WVUH Ruby Memorial Hospital who choose to participate in the study after informed consent 
is obtained.    
 
b. Selection Criteria:  Patients must be undergoing bariatric surgery at WVUH Ruby Memorial.  
They must be ASA class III of lower.  They must be between the age of 18 to 65 years old. 
 
c. Exclusion Criteria:  Hydromorphone or dexmedetomidine allergy.  ASA class IV or higher.  
Emergency surgery.  Long term narcotics usage defined as > 2 weeks.  Long term sedative 
(benzodiazepine, clonidine, hydroxyzine) usage defined as greater than 2 weeks  Bradycardia 
defined as HR < 50bpm, SBP < 100mmHg, Tachy-Brady Syndrome, 1st, 2nd or 3rd degree heart 
block, Junctional Rhythm. Severe renal or hepatic dysfunction.  Protected populations will be 
excluded from study including obstetrical patients, prisoners, students, or mentally 
handicapped.  
 
d. Recruitment Source:  Bariatric surgery patients at WVUH Ruby Memorial will be recruited in 
bariatric surgery clinic or pre-operatively by anesthesia personnel.  Dr. Quinlin performs 3 to 4 
laproscopic gastic bypasses per week with a conservative estimate of 200 operations year.  Our 


goal is 50% patient participation after voluntary participation rights and exclusion criteria have 
been applied.    
 
e. Recruitment Methods:  Subjects that meet above criteria will be asked if they wish to participate 
in study.  Risks and benefits of the study will be explained. 
 
f. 
Potential Problems:  Problems involving subject identification and recruitment by anesthesia 
personnel should be minimum.  Education  post-operative staff on PCA usage data recording will 
likely be the largest barrier. 
 
Informed Consent: Patients undergoing bariatric surgery at WVUH Ruby Memorial will be asked about 
voluntary participation in the study during preoperative visit to Bariatric Surgery Center.  Risks and 
benefits relating to the study will be explained to patient by Kristen Rosati, Physician Assistant at WVU 
Bariatric Surgery Center.  Information will be given to patient after all questions and concerns have been 
addressed.  Patient will be given opportunity to consider trial participation and informed consent 
process would take place on subsequent visit.  After inclusion and exclusion criteria have been assessed, 
the patient will then have informed consent form reviewed with them and sign informed consent form if 
they wish to participate.  Patient will be enrolled in study from this point forward. 
 
Statistical Methods: Descriptive statistics will be calculated for both groups, including means (SD) and 
frequencies (percentages) where appropriate.  Comparisons between the two groups with respect to 
binary outcomes will be done via chi-square tests, and odds ratios (95% confidence intervals) will be 
reported to quantify the magnitude of the differences observed.  The majority of the primary outcomes 
are continuous in nature, and more than likely many will be skewed, including cumulative 
hydromorphone usage.  However, given the sample size (over 30 per group), t-tests comparing the 
means of these outcomes will be able to be used.  In the event sample size targets are not reached, 
nonparametric tests (i.e., Mann-Whitney U) will be utilized.  Statistical significance will be set at alpha = 
0.05.  All data will be exported from REDCap and analyzed via SAS (version 9.3).  Power analysis reveals 
50 enrolled patients per group will provide 90% power (alpha = 0.05) to detect a difference of 0.66 
standard deviations between the two groups.  Unfortunately, no reliable standard deviation estimates 
of our primary outcome, cumulative hydromorphone at 240 minutes post-arrival to PACU, are available 
in the literature.  A conservative estimate from the Tufanogullari et al. paper (Anesthesia and Analgesia, 
2008, 106: 1741-1748) for the standard deviation of cumulative morphine in one day (not 
hydromorphone) is about 30 in either group.  Given our calculations for this hypothetical outcome, we 
would have sufficient power to see a difference of 20mg in cumulative morphine between the two 
groups, which would amount to a 40% reduction given a mean morphine level of 50mg in the control 
group.  Since we will be focusing on hydromorphone and not morphine over a shorter period of time, 
both the mean and SD of our primary outcome should be considerably smaller in a similar fashion, but 
the percent reduction that we would be able to detect statistically should remain the same.  For our 
secondary outcome of the VAS pain score, which is known to have a SD of about 3 in this population, 
100 patients will provide 90% power to detect a difference of 2 units in pain score at any given time 
point.     


Primary Endpoint: The primary endpoint will be cumulative patient hydromorphone PCA usage in the 4 
hour postoperative period. 
Secondary Endpoints:  Respiratory rate, heart rate, systolic and mean blood pressure, patient PCA 
demand bolus requests and VAS pain scores in the postoperative period. 
Timeline to Endpoints:  We anticipate a one year course for data collection to achieve our goal sample 
size.   Twelve weeks are estimated to be need for statistical calculation and results analysis.  
Costs: The subjects of this study will not incur any costs as a result of their participation.   Funding for 
dexmedetomidine will be provided by Hospira.  
Compensation and Incentives: There will be no compensation or incentives offered for anyone involved 
in this research project. 
Literature Review 
 
Bakhamees, H. S., El-Halafawy, Y. M., El-Kerdawy, H. M., Gouda, N. M., & Altemyatt, S. (2007). Effects of 
dexmedetomidine in morbidly obese patients undergoing laproscopic gastric bypass. Middle 
Eastern Journal of Anesthesia, 19(3), 537-552.  
Dholakia C, Beverstein G, Garren M, Nemergut C, Boncyk J, Gould JC.  (2007) The impact of perioperative 
dexmedetomidine infusion on postoperative narcotic use and duration of stay after laparoscopic 
bariatric surgery. J Gastrointest Surg. Nov;11(11):1556-9. Epub 2007 Aug 21. 
Schnabel, A., Meyer-Frießem, C. H., Reichl, S. U., Zahn, P. K., & Pogatzki-Zahn, E. M. (2013). Is 
intraoperative dexmedetomidine a new option for postoperative pain treatment? a meta-
analysis of randomized controlled trials. Pain, 154, 1140-1149.  
Tufanogullari, B., White, P. F., Mariana, P. P., Kianpour, D., Lacour, T., Griffin, J., Skrivanek, G., & 
Macaluso, A. (2008). Dexmedetomidine infusion during laparoscopic bariatric surgery: The effect 
on recovery outcome variables. Anesthesia and Analgesia, 106(6), 1741-1748.  
 

ICF_001.pdf: 
Human Research Protocol 
More Than Minimal Risk Form 
(With HIPAA) 
Chestnut Ridge Research Building 
886 Chestnut Ridge Road 
PO Box 6845 
Morgantown, WV 26506-6845 
P a g e | 1 
Phone: 304-293-7073 
Fax: 304-293-3098 
http://oric.research.wvu.edu 
Subject’s Initials  
 
Date  
 
Approved:16-Nov-2015Expires:21-Apr-2016Number:1306055796 
 
 
 
Principal Investigator: 
Dr. Pavithra Ranganathan, 
Department: 
Anesthesiology 
Protocol Number: 
1306055796 
Study Title: 
Does Single Intraoperative Bolus Dexmedetomidine 
Significantly Reduce Narcotic Requirements during Postoperative Period in 
Bariatric Patients? 
 
Study Personnel: 
Dr. Attaallah Ahmed, Dr. Mathew Ellison, Dr. Daniel Sizemore 
Co-Investigator(s): 
Dr. Lawrence Tabone and Dr. Mathew Gurkha. 
 
Contact Persons 
Dr. Lawrence Tabone or Dr. Pavithra Ranganathan at Ext# 79484 or pager number 2455 
In the event you experience any side effects or injury related to this research, you should 
contact Dr. Ranganathan at (304) 598-4000 pager number 2455. (After hours contact: 
Anesthesia Charge at (304) 598-4000 ext 76263). If you have any questions, concerns, or 
complaints about this research, you can contact Dr. Lawrence Tabone’s office: 304-598-4000 
ext: 74890 or pager 0081 or Dr. Pavithra Ranganathan at 304-598-4000 ext. 79484 or pager 
2455. 
For information regarding your rights as a research subject, to discuss problems, concerns, or 
suggestions related to the research, to obtain information or offer input about the research, 
contact the Office of Research Compliance at (304) 293-7073. 
In addition if you would like to discuss problems, concerns, have suggestions related to 
research, or would like to offer input about the research, contact the Office of Research 
Integrity and Compliance at 304-293-7073. 
Introduction 
You,                                                 , have been asked to participate in this research study, which 
has been Explained to you by ....................................................................This study is being 
Conducted by Dr. Lawrence Tabone and Dr. Pavithra Ranganathan in the Department of 
Anesthesiology at West Virginia University sponsored by Department of Anesthesiology at West 
Virginia University. 
 
 
 
 
 
 
Approved: 22-Apr-2015Expires:21-Apr-2016. Number: 1306055796 


Human Research Protocol 
More Than Minimal Risk Form 
(With HIPAA) 
Approved: 22-Apr-2015Expires:21-Apr-2016. Number: 1306055796 
Chestnut Ridge Research Building 
886 Chestnut Ridge Road 
PO Box 6845 
Morgantown, WV 26506-6845 
P a g e | 2 
Phone: 304-293-7073 
Fax: 304-293-3098 
http://oric.research.wvu.edu 
Subject’s Initials  
 
Date  
 
Approved:16-Nov-2015Expires:21-Apr-2016Number:1306055796 
 
 
 
 
Purpose(s) of the Study 
The purpose of the study is to determine if giving a medication called dexmedetomidine, which 
is a commonly used sedative, during weight loss surgery will reduce the amount of pain 
medications needed after surgery. 
There will be two groups in the study. Both groups will receive a standard general anesthetic 
administered by me or one of the other investigators in the study. You may either receive the 
medication- Dexmedetomidine or saline, through your IV as part of your study. During the 
recovery period you will be given a pain pump – which is a button to press if you have any pain. 
The pain pump will give you pain medication on demand. Your vital signs, your medications and 
all related information entered into your electronic medical record will be used for the study 
purposes only. 
Description of Procedures 
You will be placed in one of two groups, a control group or a study group. If you are in the 
control group (as assigned by the pharmacist) you will receive your routine general anesthetic 
and IV saline. If you are in the study group- you will receive your routine general anesthetic and 
the medication – dexmedetomidine. 
Neither the anesthesia provider nor the recovery room nurse knows which part of the study 
group you belong to. You will be randomly selected to which group you belong to; like flipping a 
coin. That information will be kept confidential and coded so that there will be no link to any 
information that identifies you. In case of any medical problems after anesthesia and surgery; 
we will access that information in order to provide appropriate medical care. 
When you awaken from surgery you will be taken to post anesthetic recovery unit commonly 
called the PACU. You will be given a pain pump with a button to press when you need pain 
medications. It will deliver your pain medication on demand by you. The amount of pain 
medication delivered to you will be routinely recorded by the PACU nurse into the electronic 
medical record. You will be kept in PACU for approximately 4 hours. You will be reevaluated by 
me or my co-investigator before you leave the PACU to go to your room. You will not 
be asked to do anything beyond what would be considered standard during the recovery 
period. You will be monitored at all times by attending anesthesiologist, anesthesia resident or 
nurse anesthetist and or PACU staff. All emergency equipment and medications will be 
immediately available to assure your safety. Rescue doses of pain medication will be readily 
available should you experience pain above and beyond what can be given to you by your pain 
pump to ensure your comfort after surgery. Your safety and comfort is our priority and we will 
not do anything that may jeopardize that. 


Human Research Protocol 
More Than Minimal Risk Form 
(With HIPAA) 
Approved: 22-Apr-2015Expires:21-Apr-2016. Number: 1306055796 
Chestnut Ridge Research Building 
886 Chestnut Ridge Road 
PO Box 6845 
Morgantown, WV 26506-6845 
P a g e | 3 
Phone: 304-293-7073 
Fax: 304-293-3098 
http://oric.research.wvu.edu 
Subject’s Initials  
 
Date  
 
Approved:16-Nov-2015Expires:21-Apr-2016Number:1306055796 
 
 
 
 
Risks and Discomforts 
It is anticipated that you will not face any additional discomfort for taking part in the study 
beyond what is considered normal for the procedure performed. However, dexmedetomidine 
does have specific side effects from including but not limited to an allergy to the medication, 
slow heart rate change in your blood pressure and sleepiness. 
Alternatives 
You do not have to participate in this study. 
Benefits 
Potential benefits to you may be a decrease in pain after surgery in the first 4 hours and a 
decrease in the side effects of the pain medications like nausea, constipation, breathing 
problems, decreased stress response during surgery and decreased anxiety after surgery. 
Financial Considerations 
You will not incur any expense or costs in relation to this study. 
HIPAA 
We know that information about you and your health is private. We are dedicated to protecting 
the privacy of that information. Because of this promise, we must get your written 
authorization (permission) before we may use or disclose your protected health information or 
share it with others for research purposes. 
You can decide to sign or not to sign this authorization section. However, if you choose not to 
sign this authorization, you will not be able to take part in the research study. Whatever choice 
you make about this research study will not have an effect on your access to medical care. 
Confidentiality 
Any information about you that is obtained as a result of your participation in this research will 
be kept as confidential as legally possible. Your research records and test results, just like 
hospital records, may be subpoenaed by court order or may be inspected by the study sponsor 
or federal regulatory authorities (including the FDA if applicable) without your additional 
consent. In addition, there are certain instances where the researcher is legally required to give 
information to the appropriate authorities. These would include mandatory reporting of 
infectious diseases, mandatory reporting of information about behavior that is imminently 
dangerous to you. In any publications that result from this research, neither your name nor any 
information from which you might be identified will be published without your consent. 
 
Persons/Organizations Providing the Information 
West Virginia University Hospitals 


Human Research Protocol 
More Than Minimal Risk Form 
(With HIPAA) 
Chestnut Ridge Research Building 
886 Chestnut Ridge Road 
PO Box 6845 
Morgantown, WV 26506-6845 
P a g e | 4 
Phone: 304-293-7073 
Fax: 304-293-3098 
http://oric.research.wvu.edu 
Subject’s Initials  
 
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Approved:16-Nov-2015Expires:21-Apr-2016Number:1306055796 
 
 
 
Persons/Organizations Receiving the Information 
• The research site(s) carrying out this study. This includes UHA or UHA Affiliated, WVU, WVU Hospitals. 
It also includes each site’s research staff and medical staff 
• Health care providers who provide services to you as part of this research study. 
• The members and staff of any Institutional Review Board (IRB) that oversees this research study. 
• West Virginia University Office of Research Compliance and Office of Sponsored Programs. 
• West Virginia University Clinical Trials Research Unit. 
The Following Information Will Be Used 
Information from your existing medical records and new information about you that is created or 
collected during the study such as, nursing and staff notes, demographic data, anesthesia record, post 
anesthesia care data and medication given to you on the day of surgery. 
The Information is Being Disclosed for the Following Reasons 
• Review of your data for quality assurance purposes 
• Publication of study results (without identifying you) 
• Other research purposes such as reviewing the safety or effectiveness of the study drug and other 
products or therapies; conducting performance reviews of the study drug; evaluating other products or 
therapies for patients; developing a better understanding of disease; improving the design of future 
clinical trials 
You May Cancel this Authorization at Any Time by Writing to the 
Principal Investigator 
Dr. Pavithra Ranganathan at ext. # 79484 or pager number 2455 email: 
ranganathanp@wvuhealthcare.com. 
Phone: 304-598-4122 One Medical Center Drive, P.O. Box 8255, Morgantown, WV 26506. 
If you cancel this authorization, any information that was collected already for this study cannot be 
withdrawn. 
Once information is disclosed, according to this authorization, the recipient may redisclose it and then 
the information may no longer be protected by federal regulations. You have a right to see and make 
copies of your medical records. You will not be able to see or copy your records related to the study 
until the sponsor has completed all work related to the study. At that time you may ask to see the study 
doctor’s files related to your participation in the study and have the study doctor correct any 
information about you that is wrong. 
This authorization will expire at the end of the study unless you cancel it before that time. 
 
 
 
 
 
 
 
Approved: 22-Apr-2015Expires:21-Apr-2016. Number: 1306055796 


Human Research Protocol 
More Than Minimal Risk Form 
(With HIPAA) 
Chestnut Ridge Research Building 
886 Chestnut Ridge Road 
PO Box 6845 
Morgantown, WV 26506-6845 
P a g e | 5 
Phone: 304-293-7073 
Fax: 304-293-3098 
http://oric.research.wvu.edu 
Subject’s Initials  
 
Date  
 
Approved:16-Nov-2015Expires:21-Apr-2016Number:1306055796 
 
 
 
 
Voluntary Participation 
Participation in this study is voluntary. You are free to withdraw your consent to participate in 
this study at any time. Refusal to participate or withdrawal will not affect your care and will 
involve no penalty to you. Refusal to participate or withdrawal will not affect your future care. 
In the event new information becomes available that may affect your willingness to participate 
in this study, this information will be given to you so that you can make an informed decision 
about whether or not to continue your participation. You have been given the opportunity to 
ask questions about the research, and you have received answers concerning areas you did not 
understand. 
Upon signing this form, you will receive a copy. 
I willingly consent to participate in this research. 
Signatures 
Signature of Subject 
 
Printed Name 
Date Time 
 
The participant has had the opportunity to have questions addressed. The participant willingly 
agrees to be in the study. 
 
Signature of Investigator or Co-Investigator 
 
Printed Name Date Time 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Approved: 22-Apr-2015Expires:21-Apr-2016. Number: 1306055796