Clinical trial NCT04992507
Conditions: Pancreatic Adenocarcinoma
Sponsor: Ohio State University Comprehensive Cancer Center
Start date: 2023-06-02; Completion date: 2024-01-26
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase II trials studies the impact of total intravenous anesthesia (TIVA) following cancer surgery. Surgery and the anesthesia delivered causes physiologic stress and trauma resulting in immune suppression. TIVA is an alternative method of general anesthesia that has several benefits over volatile inhalation agents such as reducing nausea, vomiting, and opioid consumption, and promotes earlier return of bowel function following surgery. In addition, TIVA is less immunosuppressive than inhalational agents and has been shown to decrease cancer cell proliferation, migration, and metastasis formation. Giving TIVA during cancer-directed abdominal surgery may decrease the immunosuppressive state in the peri-surgical period.

Detailed description:
PRIMARY OBJECTIVE:

I. To evaluate the impact of anesthetic agent on inflammation and immunosuppression among patients undergoing abdominal cancer surgery.

SECONDARY OBJECTIVE:

I. To determine the impact of anesthetic choice on short-term anesthetic and surgical outcomes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo surgical resection with TIVA.

ARM II: Patients undergo surgical resection with inhaled volatile anesthetics.

After completion of study treatment, patients are followed up for up to 2 years.

Arms: arm 1: Patients undergo surgical resection with TIVA. arm 2: Patients undergo surgical resection with inhaled volatile anesthetics.
Interventions: intervention 1: Anesthesia Procedure intervention 2: General Anesthesia Procedure intervention 3: Resection
Intervention descriptions: intervention 1: Given TIVA intervention 2: Given inhaled volatile anesthetics intervention 3: Undergo surgical resection

Protocol documents:
Prot_SAP_000.pdf: 
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The Impact of Total Intravenous Anesthesia Following Cancer Surgery 
(TIVACS) Study 
 
Principal Investigator  
Aslam Ejaz, MD, MPH 
Assistant Professor of Surgery 
Department of Surgery / Division of Surgical Oncology 
The Ohio State University Wexner Medical Center  
614-293-7171 
Aslam.Ejaz@osumc.edu 
 
 
Sponsor : 2020 Fall IRP Clinical Trial Award 
 
 
 
 
 
 
 
 
 
 
 
 


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Table of Contents 
I. Hypothesis / Objectives ............................................................................................................................. 3 
Objectives ................................................................................................................................................. 3 
Primary Objective.................................................................................................................................. 3 
Secondary Objective ............................................................................................................................. 3 
II. Background and Rationale ........................................................................................................................ 3 
III. Procedures ............................................................................................................................................... 5 
A. Research Design .................................................................................................................................... 5 
B. Sample .................................................................................................................................................. 6 
Inclusions: ............................................................................................................................................. 6 
Exclusions: ............................................................................................................................................. 7 
C. Measurement / Instrumentation .......................................................................................................... 7 
D. Detailed study procedures ................................................................................................................... 8 
E. Data Analysis ........................................................................................................................................... 10 
IV. Data and Safety Monitoring ................................................................................................................... 11 
V. Regulatory ............................................................................................................................................... 11 
VI. Bibliography ........................................................................................................................................... 12 
Appendix A .................................................................................................................................................. 14 
 
 
 
 


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I. Hypothesis / Objectives 
We hypothesize that total intravenous anesthesia (TIVA) used during cancer-directed 
abdominal surgery will decrease the immunosuppressive state in the peri-surgical period as 
measured by NET activation in the circulation.  
 
 
Objectives 
Primary Objective  - To evaluate the impact of anesthetic agent on inflammation and 
immunosuppression among patients undergoing abdominal cancer surgery 
Secondary Objective – To determine the impact of anesthetic choice on short-term anesthetic 
and surgical outcomes 
 
Primary Endpoint –  
1. Circulating levels of myeloperoxidase (MPO)-DNA complexes, which represent NET 
formation 
Secondary Endpoints –  
1. Circulating inflammatory cytokines (TGF-β, IL-17, IFN-g, TNF-a, IL-6) 
2. Circulating immune cell levels (CD3+ CD4+ and CD8+ T-cells and B cells) 
3. Circulating levels of markers of systemic inflammation (ESR, CRP) 
4. Postoperative nausea scores 
5. Frequency of antiemetic administration 
6. Total hospital opioid use (total morphine equivalents) 
7. Post-operative cognitive impairment, as measured by the Saint Louis University Mental 
Status (SLUMS) Examination 
8. Surgical morbidity as measured by the comprehensive complication index 
9. Overall survival 
10. Disease-free survival, defined as time from surgery to recurrence, or death 
II. Background and Rationale  
Surgical resection is the central treatment for many abdominal solid organ cancers, yet 
upwards of 1 in 3 patients will experience a local or distant recurrence of disease following 
resection.1 For patients undergoing surgery for pancreatic cancer, one major contributor to the 
development and progression of cancer following curative-intent surgery is immune 
suppression. Surgery and the anesthesia delivered causes physiologic stress and trauma 
resulting in immune suppression.2-4 This immunosuppressive state contributes to the 
development of a post-operative pre-metastatic niche that promotes tumor recurrence.2-4  As 
opposed to the commonly used volatile inhalation agents, the use of total intravenous 


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anesthesia (TIVA) is thought to blunt this immunosuppressive state, and is associated with 
improved cancer outcomes.5-8 
General anesthesia administered with volatile inhalational agents are 
immunsuppressive,9 tumorgenic10, and prometastatic.11,12 Through the use of the intravenous 
anesthetic Propofol, TIVA is an alternative method of general anesthesia that has several 
benefits over volatile inhalation agents. TIVA reduces nausea, vomiting, and opioid 
consumption, promotes earlier return of bowel function following surgery, and decreases post-
operative delirium in patients with pre-existing mild cognitive impariment.11,13 In addition, TIVA 
is less immunosuppressive than inhalational agents and has been shown to decrease cancer cell 
proliferation, migration, and metastasis 
formation.5-7 Previous retrospective studies 
have associated TIVA with improved disease 
specific and overall survival among cancer 
patients undergoing surgery.8,14-20 Despite 
these and other clinical and oncologic 
benefits (Figure 1), the adoption and use of 
TIVA in general practice is limited.11,21  
One method in detecting early cancer 
progression following surgery for pancreatic 
cancer is through the detection of reliable 
blood biomarkers. Recent studies have 
shown that exaggerated neutrophil 
activation and formation of circulating 
neutrophil extracellular trap (NETs) are 
linked to tumor progression and metastasis. 
22-25 Furthermore, NETs found in resected 
tumor tissue are associated with worse 
recurrence-free and overall survival following cancer surgery.26 Within the tumor micro-
environment, NETs are known to mediate resistance to immune checkpoint inhibitors. 27 
Through immunomodulatory effects, preliminary studies have suggested propofol decreases 
NET formation in animal models.28,29 These findings provide evidence for the central hypothesis 
that TIVA use during cancer-directed surgery will decrease the immunosuppressive state in the 
peri-surgical period as measured by NET activation in the circulation. 
There are recent discoveries suggesting that NETs formation is involved in the tumor 
microenvironment (TME). NET formation in the TME could be the initiator of disease or a side 
effect of the general overwhelming response of the immune system. There is potential for NET-
related molecules to be used as biomarkers and as targets for therapeutic intervention in 
cancer-related diseases. Important progress has been made to show that NETs may induce 
tumor proliferation, distant metastasis, and tumor-associated thrombosis. The 
immunosuppressive role of NETs has been recently studied in pancreatic ductal 
adenocarcinoma (PDAC) where remains a lethal malignancy with an immunosuppressive 


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microenvironment that is resistant to most therapies. It has recently been shown that NETs are 
the mechanism that maintaining immunosuppression and resistance to immunotherapy in 
pancreatic ductal adenocarcinoma (PDAC). NETs were found to be triggered in PDAC by IL17 
and exclude cytotoxic CD8 T cells form tumors. Inhibition of Padi4-dependent NET formation 
increases immune checkpoint blockade (PD-1, CTLA4) sensitivity. Higher expression of PADI4 
(promote NET formation) in human PDAC corresponds with a poorer prognosis, and the serum 
of patients with PDAC has a higher potential for NETosis. Therefore, inhibition of NETs to 
suppress immunosuppression may have a beneficial function in cancer development. A better 
understanding of the function and impact of NETs on cancer patients will enable the 
suppression of their detrimental attributes and ultimately, allow us to exploit therapeutic 
strategies for NETs to treat cancer.  
III. Procedures  
A. Research Design  
This is a randomized controlled pilot study. All patients with pancreatic adenocarcinoma that 
present at the Martha Morehouse Outpatient clinics between 1 May, 2023 and March 31, 2025 
and scheduled to undergo surgical resection will be eligible for the study. 
 
Enrolled subjects will be randomized 1:1 among those to receive either TIVA (n=40) or volatile 
inhalation agents (n=40). Randomization will be stratified based on the receipt of neoadjuvant 
chemotherapy and surgical procedure (whipple vs distal pancreatectomy) and accomplished by 
the random permuted block methodology through a computer-generated mechanism. 
Randomization will be performed the day prior to the surgical procedure. The anesthesia and 
operating room staff will be notified of the randomization results via email. 


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Patients will be randomized prior to the day of surgery by the research staff. The research staff 
will then inform the attending anesthesiologist and operating room staff assigned to the 
operation of the randomization details the day before surgery.  Blood samples will be drawn 
pre-operatively, immediately postoperatively, on post-operative days (POD) 1  during morning 
laboratory evaluations and at post-operative visits at 4 weeks, 3 months, and 1 year.  Patients 
will be followed for recurrence and survival for two years post-operatively, which is also the 
end of study (EOS).  All blood specimen analysis will be performed by Dr. Mark Rubinstein’s 
laboratory in BRT 550A/B, and subsequently stored until study completion. (See Schedule of 
Events – pg 6) 
 
Following pancreatic resection, all patients will be treated according to standard post-operative 
clinical protocols, which include basic laboratory analysis every morning and at post-operative 
visits. Research labs will be drawn at the time of standard clinical labs. 
 
B. Sample  
We plan to enroll 80 patients in total, with 40 in each group, over two years between 1 May 
2023,  and  March 31, 2025. 
 
Inclusions: 
• 
Adults: ≥18 years old on the day of consent 
• 
Non-metastatic pancreatic adenocarcinoma 
• 
Able to provide consent 


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• 
ECOG performance status of 0 or 1 
• 
Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy 
test for the patient at the time of surgery. 
• 
Ability to understand and the willingness to sign a written informed consent document. 
 
Exclusions: 
• 
Previous identified allergy or hypersensitivity to any component of the study treatment  
• 
Allergies to eggs, egg products, soybeans, or soy products 
• 
Personal or first degree relative with a history of malignant hyperthermia  
• 
Has a known additional malignancy that is expected to require active treatment within two 
years, or is likely to be life-limiting in the opinion of the treating investigator. Superficial 
bladder cancer, non-melanoma skin cancers, or low-grade prostate cancer not requiring 
therapy would not exclude participation in this trial.  
• 
Uncontrolled intercurrent illness including, but not limited to: Symptomatic congestive heart 
failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations 
that would limit compliance with study requirements.  
• 
Pregnant or lactating females 
• 
Major surgery within 2 months before enrollment. Complete healing from major surgery 
must have occurred 1 month before enrollment. Complete healing from minor surgery (eg, 
simple excision, tooth extraction) must have occurred at least 7 days before enrollment. 
Subjects with clinically relevant complications from prior surgery are not eligible.  
o Patients who undergo reoperation during their initial hospitalization will be 
censored at the time of reoperation.   
• 
Prisoner status 
 
C. Measurement / Instrumentation  
Study subjects age, gender, tumor characteristics, medical history, medications will be 
recorded. Markers of inflammation and immunosuppression will be measured through 
circulating levels of myeloperoxidase (MPO)-DNA complexes, which represent NET 
formation24, at multiple pre- and postoperative time points. Other measures of circulating 
immune cells (CD3+ CD4+ and CD8+ T-cells and B cells), levels of immune cytokines (IL-2, IL-4, 
IL-5, IL-6, IL-10, IL-12, IL-17, TGF-β, IFN-g, TNF-a) and inflammatory markers (ESR, CRP) 
implicated in anesthesia-mediated immune suppression, tumorigenesis, and metastasis 
development will also be measured.  Patients will also receive daily post-operative labs as part 
of standard clinical care. 
 
We will evaluate clinical anesthetic (post-operative nausea and vomiting, opioid consumption, 
post-operative cognitive impairment) and surgical (return of bowel function, surgical morbidity 
within 90 days, mortality within 90 days) outcomes based on type of anesthesia received. 
Furthermore, we will attempt to correlate adverse anesthetic and surgical outcomes with 


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circulating NET levels. Enrolled subject’s medical records will be reviewed approximately every 
3 months for outcomes for a total of two years. 
 
D. Detailed study procedures  
Following consent for pancreatectomy at their preoperative surgical appointment, the study 
team will explain the clinical trial and provide a copy of the Informed Consent Form to the 
patient.  All patients undergoing pancreatectomy are referred to the OSU Preoperative 
Assessment Clinic (OPAC), which is always staffed by an anesthesia attending.  Patients 
interested in this clinical trial will have that noted in their OPAC referral.  At the OPAC 
appointment, the anesthesia attending will confirm they are medically stable for either 
anesthesia approach and consent them for general anesthesia.  Permuted block randomization 
will be used to allocate the patients to treatment or control group. Following, randomization 
will be performed by a computer-generated method by the research staff.  Patients will be 
randomized based on the receipt of neoadjuvant chemotherapy, clinical stage at diagnosis 
(primary resectable vs borderline resectable or locally advanced), and surgical procedure 
(whipple vs distal pancreatectomy). OPAC documentation will include that the patient has 
consented for the trial and has been randomized, but will not contain the arm they are 
randomized. The randomization arm will be entered into the OnCore system. Anesthesia 
assignments are finalized the day before surgery, and at that time, the anesthesia team 
(attending anesthesiologist, CRNA, anesthesia resident) will receive an email from the team 
with the patient’s randomization assignment.  On the morning of surgery, the surgery and 
anesthesia teams will meet the patient and answer any final questions about the trial.  Intra-
operatively, patients will receive general anesthesia within the standard guidelines of the OSU 
Department of Anesthesiology. Patients will be treated according to standard of care clinical 
pathways. Propofol is a widely used induction agent and is used even if patients receive volatile 
anesthesia.  The use of propofol for induction in patients randomized to receive volatile 
anesthesia is permitted.  Currently, anesthetic choice is largely based on provider preferences.11 
Both Propofol-based TIVA and inhaled volatile anesthetics are FDA-approved methods of 
anesthesia during cancer surgery, are safe, and are familiar to members of the anesthesia staff 
at OSU and The James. As post-operative care for a patient who has undergone pancreas 
resection is standardized within the division of surgical oncology and independent of type of 
anesthesia delivered, blinding will not be performed. The anesthesia and operating room staff 
and faculty will be aware of the randomization. 
 
Enrolled subjects will be registered in OSU’s OnCore system as well as stored in the PIs REDCap 
database. Electronic data will be located on password protect university network computers or 
REDCap. REDCap instance is located on an internal OSUWMC network. Remote access to this 
network can be obtained over an encrypted VPN tunnel (AnyConnect). This VPN uses Protocol: 
DTLS and Cipher: RSA_AES_128_SHA1. Background checks are performed on all staff that are 
on the network or obtaining VPN access. 
 
 


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Schedule of Events 
 
V0 
V1 
POD-0 
(DOS) 
V2 
POD-1* 
V3 
4 weeks 
(±2 weeks) 
V4 
3 m 
(±4 weeks) 
V5 
1 yr 
(± 4 week) 
LTFU/EOS 
Consent 
x 
 
 
 
 
 
 
Eligibility  
x 
 
 
 
 
 
 
Med History / 
Physical Exam 
x 
 
 
 
 
 
 
Medications 
x 
 
 
 
 
 
 
Randomization
1 
x 
 
 
 
 
 
 
Blood draw* 
x 
x 
x 
x 
x 
 
X 
 
Med Record  
Review 
x 
 
 
x 
x 
 
X 
x 
AE / SAE 
 
x 
x 
 
 
 
 
 
AE – adverse event 
SAE – serious adverse event 
EOS – End of Study 
LTFU – Long term follow-up (up to 2 years) 
DOS – day of surgery 
1will occur prior to day of surgery, but may not occur on V0 
*within the day at time of other clinical labs  
 
Patients who withdraw their research consent prior to surgery will be withdrawn from the 
study.  Patients whose surgery is cancelled and not rescheduled will be withdrawn from the 
study.  Patients who require a change in anesthetic approach intra-operatively will be followed 
with blood draws as originally planned, and the reason for change in anesthesia plan will be 
documented by the attending anesthesiologist and reported to the IRB. Patients who are 
unexpectedly unable to undergo a curative-intent pancreas resection (ie. aborted procedure) 
will be removed from the study, as will subjects who undergo reoperation during their index 
hospitalization. Subjects will be informed however, they may choose to leave the study at any 
time. 
 
Both anesthetic approaches use FDA approved medications and equipment and are NOT 
experimental anesthetic techniques, but rather are standard of care techniques that 
anesthesiologists are expected to have mastered over the course of training. Neither approach 
poses a significant risk to the patient.  
 


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All subjects will have their blood drawn per the established procedure for biospecimen 
collection in the Martha Morehouse Outpatient Center or the James Cancer Hospital. About 30 
cc of peripheral blood in heparinized solid green top tubes, and/or red top serum separator 
tubes, will be drawn from patients once consent has been signed at each time point. Samples 
will be processed and stored in the laboratory of Dr. Mark Rubinstein, in the Biomedical 
Research Tower at The Ohio State University, identified with their study ID number.  Research 
blood will be drawn at the time of standard clinical blood draws and then held for Dr. 
Rubinstein’s lab.  After processing of blood samples within 24 hours of the blood draw, will be 
stored in a –70° C freezer or in liquid nitrogen in the Rubinstein lab until subsequent analysis. 
The cytokine panel is based on previous studies which have investigated the role of anesthesia 
delivery on post-operative immunosuppression and cancer outcomes.  
 
 
E. Data Analysis  
Clinical data on the impact of anesthetic agents on NET formation are lacking.  In vitro 
experiments have shown that Propofol decreases NET formation approximately 20% when 
compared to baseline levels.22,23 In this pilot trial, we are assuming there is a 10% difference in 
NET levels between inhaled anesthetics and Propofol-based TIVA. A repeated measures design 
has two treatment groups, and a total of 80 patients (32 patients per group and we anticipate a 
follow-up loss rate of 20%, so we will enroll 40 patients per group) are needed. NETs will be 
measured at 8 different post-anesthesia time points as described. This trial design achieves 80% 
power to test the 10% group difference with a standard deviation of 0.08 using a Geisser-
Greenhouse Corrected F Test for a two-sided 5% significance level, and the medium effect size 
of 0.3.  Previous translational studies536-42 have identified differences in circulating cytokine 
levels and immune cell phenotypes with sample sizes of 40 patients / arm or fewer. For the 
repeated measurements of continuous variables (NET, Circulating inflammatory cytokines, 
immune cell levels and markers of systemic inflammation), linear mixed model accounting for 
within-subject correlations of different time points and individual differences will be used for 
the comparisons of effects of TIVA and inhaled Volatile anesthetics. In addition, time under 
general anesthesia, amount of medication administered, and the presence or absence of major 
vein or artery resection during surgery will be adjusted in the mixed effect model. Furthermore, 
type of operative approach (open vs. minimally-invasive) as well as pathologic stage (TNM) will 
be adjusted in the mixed effect model. T-test will be applied to compare the baseline 
continuous variables (age, tumor characteristics), nausea scores, frequency of antiemetic 
administration, and Chi2 test will be used to assess the baseline categorical variables (gender, 
medications) of the TIVA and inhaled Volatile anesthetics groups. Surgical morbidity (measured 
by the comprehensive complication index) will be compared using two sample T test. Kaplan–
Meier estimator and Logrank test will be employed to compare overall survival and disease-free 
survival analysis. Cox’s proportional hazards model will be used for multivariable survival 
regression analysis. We will carefully check model assumptions, and in the event that violations 


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are detected, appropriate transformations or non-parametric analysis method will be used. For 
multiple comparisons, the adjusted p-values will be reported. A two-sided p-value < 0.05 will be 
considered statistically significant.    
We will monitor short-term peri-operative and anesthetic outcomes based on the anesthetic 
agent of choice.  The incidence of these outcomes will also be associated with NET levels. We 
expect increased NETs among patients with worse short-term surgical and anesthetic 
outcomes. Return of bowel function will be measured by concordance with our institutional 
post-pancreatectomy clinical pathway. Post-operative nausea and vomiting will be measured by 
nursing evaluated nausea scores and frequency of antiemetic medication administration. To 
quantitatively assess the degree of post-operative pain, we will measure total oral morphine 
equivalents during the patient’s hospital stay. Post-operative cognitive impairment will be 
assessed using the Saint Louis University Mental Status (SLUMS) Examination in the pre-
operative clinic, the morning of the first post-operative day, the day of discharge, and at post-
operative clinical visits.  Surgical morbidity will be assessed using standardized case report 
forms, and complication burden will then be calculated using the Comprehensive Complication 
Index (CCI) 30. This method is more powerful than standard binary measures of morbidity 
(presence/absence of individual events) as it presents a quantitative score based on an 
aggregate weighted total ranging from 0 (no complications) to 100 (death). 
IV. Data and Safety Monitoring 
The data and safety monitoring plan will involve the continuous evaluation of safety, data 
quality and data timeliness. Investigators will conduct continuous review of data and patient 
safety at their regular Disease Group meetings (at least monthly). The PI of the trial will review 
toxicities and responses of the trial where applicable at these disease center meetings and 
determine if the risk/benefit ratio of the trial changes. Frequency and severity of adverse 
events will be reviewed by the PI and compared to what is known about the agent/device from 
other sources; including published literature, scientific meetings and discussions with the 
sponsors, to determine if the trial should be terminated before completion. Serious adverse 
events and responses will also be reviewed by the OSUCCC Data and Safety Monitoring 
Committee (DSMC). All Serious Adverse Events are to be submitted to the DSMC for their 
review. 
V. Regulatory  
Before protocol-specified procedures are carried out, consenting professionals approved on the 
study, will explain full details of the protocol and study procedures as well as the risks involved, 
aspects of patient privacy concerning research specific information, Research Authorization to 
participants prior to their inclusion in the study. Participants will also be informed that 
participation is voluntary and that they are free to withdraw from the study at any time. All 


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patients must sign an IRB approved consent form indicating their consent to participate. The 
participant must receive a copy of the signed informed consent form.  
Patient information will be stored in a secured, computerized database that is behind the Ohio 
State University Wexner Medical Center firewall. Only study personnel will have access to these 
records. Any hard copies of study-related materials will be kept in locked cabinets within the 
CTO offices, only accessible to approved research personnel.  
VI. Bibliography  
1. 
Yap A, Lopez-Olivo MA, Dubowitz J, Hiller J, Riedel B. Anesthetic technique and cancer 
outcomes: a meta-analysis of total intravenous versus volatile anesthesia. Can J Anaesth. 
2019;66(5):546-561. 
2. 
Hiller JG, Perry NJ, Poulogiannis G, Riedel B, Sloan EK. Perioperative events influence cancer 
recurrence risk after surgery. Nat Rev Clin Oncol. 2018;15(4):205-218. 
3. 
Chen Z, Zhang P, Xu Y, et al. Surgical stress and cancer progression: the twisted tango. Mol 
Cancer. 2019;18(1):132. 
4. 
Tohme S, Simmons RL, Tsung A. Surgery for Cancer: A Trigger for Metastases. Cancer research. 
2017;77(7):1548-1552. 
5. 
Inada T, Yamanouchi Y, Jomura S, et al. Effect of propofol and isoflurane anaesthesia on the 
immune response to surgery. Anaesthesia. 2004;59(10):954-959. 
6. 
Mammoto T MM, Mammoto A, Yamanaka Y, Hayashi Y, Mashimo T, Kishi Y Nakamura H. 
Intravenous anesthetic, propofol inhibits invasion of cancer cells. Cancer Letters. 2002;184:165-
170. 
7. 
Yang C, Gao J, Yan N, et al. Propofol inhibits the growth and survival of gastric cancer cells in 
vitro through the upregulation of ING3. Oncol Rep. 2017;37(1):587-593. 
8. 
Chang CY, Wu MY, Chien YJ, Su IM, Wang SC, Kao MC. Anesthesia and Long-term Oncological 
Outcomes: A Systematic Review and Meta-analysis. Anesthesia and analgesia. 2021;132(3):623-
634. 
9. 
Stollings LM, Jia LJ, Tang P, Dou H, Lu B, Xu Y. Immune Modulation by Volatile Anesthetics. 
Anesthesiology. 2016;125(2):399-411. 
10. 
Luo X, Zhao H, Hennah L, et al. Impact of isoflurane on malignant capability of ovarian cancer in 
vitro. Br J Anaesth. 2015;114(5):831-839. 
11. 
Lim A, Braat S, Hiller J, Riedel B. Inhalational versus propofol-based total intravenous 
anaesthesia: practice patterns and perspectives among Australasian anaesthetists. Anaesth 
Intensive Care. 2018;46(5):480-487. 
12. 
Zhu M, Li M, Zhou Y, et al. Isoflurane enhances the malignant potential of glioblastoma stem 
cells by promoting their viability, mobility in vitro and migratory capacity in vivo. Br J Anaesth. 
2016;116(6):870-877. 
13. 
Tang N, Ou C, Liu Y, Zuo Y, Bai Y. Effect of inhalational anaesthetic on postoperative cognitive 
dysfunction following radical rectal resection in elderly patients with mild cognitive impairment. 
J Int Med Res. 2014;42(6):1252-1261. 
14. 
Wigmore TJ, Mohammed K, Jhanji S. Long-term Survival for Patients Undergoing Volatile versus 
IV Anesthesia for Cancer Surgery: A Retrospective Analysis. Anesthesiology. 2016;124(1):69-79. 


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15. 
Lee JH, Kang SH, Kim Y, Kim HA, Kim BS. Effects of propofol-based total intravenous anesthesia 
on recurrence and overall survival in patients after modified radical mastectomy: a retrospective 
study. Korean journal of anesthesiology. 2016;69(2):126-132. 
16. 
Wu ZF, Lee MS, Wong CS, et al. Propofol-based Total Intravenous Anesthesia Is Associated with 
Better Survival Than Desflurane Anesthesia in Colon Cancer Surgery. Anesthesiology. 
2018;129(5):932-941. 
17. 
Zheng X, Wang Y, Dong L, et al. Effects of propofol-based total intravenous anesthesia on gastric 
cancer: a retrospective study. Onco Targets Ther. 2018;11:1141-1148. 
18. 
Lai HC, Lee MS, Lin C, et al. Propofol-based total intravenous anaesthesia is associated with 
better survival than desflurane anaesthesia in hepatectomy for hepatocellular carcinoma: a 
retrospective cohort study. Br J Anaesth. 2019;123(2):151-160. 
19. 
Lai HC, Lee MS, Lin KT, et al. Propofol-based total intravenous anesthesia is associated with 
better survival than desflurane anesthesia in intrahepatic cholangiocarcinoma surgery. 
Medicine. 2019;98(51):e18472. 
20. 
Lai HC, Lee MS, Lin KT, et al. Propofol-based total intravenous anesthesia is associated with 
better survival than desflurane anesthesia in robot-assisted radical prostatectomy. PloS one. 
2020;15(3):e0230290. 
21. 
Wong GTC, Choi SW, Tran DH, Kulkarni H, Irwin MG. An international survey evaluating factors 
influencing the use of total intravenous anaesthesia. Anaesth Intensive Care. 2018;46(3):332-
338. 
22. 
Kos K, de Visser KE. Neutrophils create a fertile soil for metastasis. Cancer Cell. 2021. 
23. 
Tohme S, Yazdani HO, Al-Khafaji AB, et al. Neutrophil Extracellular Traps Promote the 
Development and Progression of Liver Metastases after Surgical Stress. Cancer research. 
2016;76(6):1367-1380. 
24. 
Albrengues J, Shields MA, Ng D, et al. Neutrophil extracellular traps produced during 
inflammation awaken dormant cancer cells in mice. Science. 2018;361(6409). 
25. 
Yang L, Liu Q, Zhang X, et al. DNA of neutrophil extracellular traps promotes cancer metastasis 
via CCDC25. Nature. 2020;583(7814):133-138. 
26. 
Jin W, Xu HX, Zhang SR, et al. Tumor-Infiltrating NETs Predict Postsurgical Survival in Patients 
with Pancreatic Ductal Adenocarcinoma. Annals of surgical oncology. 2019;26(2):635-643. 
27. 
Zhang Y, Chandra V, Riquelme Sanchez E, et al. Interleukin-17-induced neutrophil extracellular 
traps mediate resistance to checkpoint blockade in pancreatic cancer. J Exp Med. 2020;217(12). 
28. 
Chen MS, Lin WC, Yeh HT, Hu CL, Sheu SM. Propofol specifically reduces PMA-induced 
neutrophil extracellular trap formation through inhibition of p-ERK and HOCl. Life Sci. 
2019;221:178-186. 
29. 
Meier A, Chien J, Hobohm L, Patras KA, Nizet V, Corriden R. Inhibition of Human Neutrophil 
Extracellular Trap (NET) Production by Propofol and Lipid Emulsion. Front Pharmacol. 
2019;10:323. 
30. 
Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: 
a novel continuous scale to measure surgical morbidity. Annals of surgery. 2013;258(1):1-7. 
 
 
 
 


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IRB Approval Date: 7/17/2023 
Version: 1.6 
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Appendix A 
Package Insert 
 


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ICF_001.pdf: 
CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2022C0114 
IRB Approval date:  7/17/2023 
Version:  6/20/2023 
 
 
Page 1 of 14 
Form date: 
04/19/2021 
 
The Ohio State University Combined Consent to Participate in 
Research and HIPAA Research Authorization 
 
Study Title: 
The Impact of Total Intravenous Anesthesia Following 
Cancer Surgery (TIVACS) Study 
Principal Investigator: 
Aslam Ejaz, MD, MPH 
Sponsor:  
The Ohio State University 
Funding Support: 
Pelotonia 
 
• This is a consent form for research participation.  It contains important information 
about this study and what to expect if you decide to participate.  Please consider the 
information carefully. Feel free to discuss the study with your friends and family and 
to ask questions before making your decision whether or not to participate. 
• Your participation is voluntary.  You may refuse to participate in this study.  If you 
decide to take part in the study, you may leave the study at any time.  No matter what 
decision you make, there will be no penalty to you and you will not lose any of your 
usual benefits.  Your decision will not affect your future relationship with The Ohio 
State University.  If you are a student or employee at Ohio State, your decision will 
not affect your grades or employment status. 
• You may or may not benefit as a result of participating in this study.  Also, as 
explained below, your participation may result in unintended or harmful effects for 
you that may be minor or may be serious depending on the nature of the research. 
• You will be provided with any new information that develops during the study 
that may affect your decision whether or not to continue to participate.  If you 
decide to participate, you will be asked to sign this form and will receive a copy of the 
form.  You are being asked to consider participating in this study for the reasons 
explained below. 
 
Key Information About This Study 
The following is a short summary to help you decide whether or not to be a part of this study. 
More detailed information is listed later in this form.  
 
You are being asked to take part in this study because you have been diagnosed with 
pancreatic cancer and will soon be undergoing surgery to remove the tumor. This study is 
being done to understand the safety and effectiveness of two types of anesthetics (volatile 
inhalation agents and total intravenous anesthesia (TIVA)) used for patients having abdominal 
cancer surgery. It is thought that TIVA lessons immune system suppression (weakness) which 
leads to better cancer outcomes. The anesthetic, Propofol, will be used for either delivery 
method. 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2022C0114 
IRB Approval date:  7/17/2023 
Version:  6/20/2023 
 
 
Page 2 of 14 
Form date: 
04/19/2021 
 
 
• If you choose to participate, you will remain on the study for approximately 2 years. 
You will undergo several medical procedures during this study, including blood draws 
and physical exams. 
 
• Side effects: 
 
o Common side effects of Propofol include: irregular heart rate, irregular blood 
pressure, injection site reactions, apnea (short stoppage of breathing), rash, 
itching, blurred vision, confusion, headache, nervousness, pounding in ears, 
problems with movement, sweating, and unusual tiredness or weakness. 
 
o Blood draw risks include: pain, swelling, bruising, and tissue discoloration or 
scarring around the vein used to draw the blood sample. 
 
• You may or may not benefit directly from participating in the study. However, the 
study doctors hope that information gained in this clinical study will help determine 
the best method of anesthesia for patients with pancreatic cancer undergoing surgery 
to improve cancer outcomes. 
 
• You do not have to take part in this clinical trial and may still receive cancer care at 
The Ohio State University without taking part. 
 
 
1. Why is this study being done? 
 
You are being asked to take part in this study because you have been diagnosed with 
pancreatic cancer that has not spread and will soon be undergoing surgery to remove the 
tumor. 
 
This study is being done to understand the safety and effectiveness of two types of 
sedatives used for patients having abdominal cancer surgery. Surgical removal of 
abdominal solid organ cancers is the primary treatment for many of these types of cancers. 
However, almost one in three of these patients will have their cancer return after surgery. 
Patients who have surgery for pancreatic cancer may see progression of their cancer 
following surgery because their immune system is weakened. The normal sedative agents 
used for abdominal cancer surgeries are inhaled by patients. Studies show that the use of 
TIVA decreases immune system weakness and, therefore, may improve cancer outcomes. 
 
TIVA is a method of general anesthesia that may have several benefits over inhaled 
sedatives. It reduces side effects such as nausea and vomiting, leads to quicker return of 
bowel function after surgery, and is less immunosuppressive than inhaled sedatives. It has 
also been shown to decrease cancer cell growth. However, even with these and other 
benefits, TIVA is not normally used. 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2022C0114 
IRB Approval date:  7/17/2023 
Version:  6/20/2023 
 
 
Page 3 of 14 
Form date: 
04/19/2021 
 
 
One way to identify early cancer progression after pancreatic cancer surgery is through 
blood biomarkers (particles in the blood) that show there may be disease present. Early 
studies have shown that propofol decreases the formation of these biomarkers in animal 
models. This means that TIVA use during surgery may decrease the chance of the immune 
system being weakened. 
 
This study is being done to assess how different sedatives can affect anesthetic and 
surgical outcomes by evaluating the level of inflammation and weakness of the immune 
system of patients having abdominal cancer surgery. 
 
 
2. How many people will take part in this study? 
 
Up to 96 participants may take part in this study at the Ohio State University. Some may 
not be eligible to participate or may decide on their own not to participate. Approximately 
80 participants, 40 in each group, will undergo one of the study treatments and be 
followed for safety and effectiveness of the surgical methods. 
 
 
3. What will happen if I take part in this study? 
 
If you agree to take part in this study, you will first be asked to sign this consent form. 
Your medical records will be reviewed for eligibility. If you meet the eligibility criteria 
needed to participate in the study, you will then be enrolled. 
 
Once it has been determined that you are eligible to participate in this study, you will be 
randomized to one of the two study arms. The randomization process is similar to a coin 
flip. You will be randomized to either the control arm which is surgical resection with 
volatile inhalation agents or the treatment arm which is surgical resection with total 
intravenous anesthesia (TIVA). This randomization will be based on the receipt of 
neoadjuvant chemotherapy (chemotherapy given before surgery), your clinical stage when 
you were diagnosed, and the type of surgical procedure you will be undergoing. Neither 
you nor your surgeon will know which type of anesthesia was delivered. The study team 
will inform the anesthesiologist who will be delivering the anesthesia to you during the 
surgery the day before the surgery. 
 
You will have research labs drawn before your surgery, immediately after your surgery, 
on post-operative days 1 during morning laboratory evaluations, at post-operative visits at 
4 weeks and 3 months. Your lab samples will be stored until study completion. You will 
be followed for recurrence of your cancer and survival every 3 months for two years after 
your surgery.  
 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2022C0114 
IRB Approval date:  7/17/2023 
Version:  6/20/2023 
 
 
Page 4 of 14 
Form date: 
04/19/2021 
 
At each study visit your doctor will ask you if you have experienced any side effects that 
are listed in Section 6 of this document or if you have experienced any other side effects. 
 
 
Study visits: 
 
Visit 0: 
• Study consent form will be discussed with you. 
• Your current medications will be recorded. 
• You will complete a physical examination. 
• Your blood will be drawn. 
• Randomization (random assignment to one of two anesthetic measures, similar to a 
coin flip) 
 
Visit 1 (Date of surgery): 
• Your blood will be drawn. 
• Your side effects will be assessed. 
 
Visit 2 (Post-Operative Days 1 ): 
• Your blood will be drawn. 
• Your side effects will be assessed. 
 
Visit 3 (4 weeks [+/- 2 weeks] after surgery): 
• Your blood will be drawn. 
• Your medical records will be reviewed to evaluate your health status as well as to 
assess if your cancer has returned. 
• Your side effects will be assessed. 
 
Visit 4 (3 months [+/- 4 weeks] after surgery): 
• Your blood will be drawn. 
• Your medical records will be reviewed to evaluate your health status as well as to 
assess if your cancer has returned. 
• Your side effects will be assessed. 
 
Visit 5 (1 year [+/- 4 week]) 
• Your blood will be drawn. 
• Your medical records will be reviewed to evaluate your health status as well as to 
assess if your cancer has returned. 
 
Every 3 months for 2 years (Long Term Follow-Up [LTFU]): 
Your medical records will be reviewed to evaluate your health status as well as to 
assess if your cancer has returned. 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2022C0114 
IRB Approval date:  7/17/2023 
Version:  6/20/2023 
 
 
Page 5 of 14 
Form date: 
04/19/2021 
 
STUDY CALENDAR: 
 
 
Visit 0 
Visit 1 
(Day of 
surgery) 
Visit 2 
(post-op 
Day 1) 
Visit 3  
(4 weeks after 
surgery) 
(+/- 2 weeks) 
Visit 4  
(3 months 
after surgery) 
(+/- 4 weeks) 
V5 
1 yr 
(± 4 week) 
Long Term 
Follow-up/End 
of Study 
Consent 
x 
 
 
 
 
 
 
Eligibility  
x 
 
 
 
 
 
 
Med History / 
Physical Exam 
x 
 
 
 
 
 
 
Medications 
x 
 
 
 
 
 
 
Randomization 
x 
 
 
 
 
 
 
Blood draw 
x 
x 
x 
x 
x 
X 
 
Med Record  
Review 
x 
 
 
x 
x 
X 
x 
Side Effect 
Review 
 
x 
x 
 
 
 
 
 
 
4. How long will I be in the study? 
 
You will be on the study for approximately 2 years. You will have blood draws done prior 
to your surgery, immediately after the surgery, at 4 weeks and at 3 months. Your medical 
records will be reviewed approximately every 3 months for a total of 2 years to assess if 
your cancer has returned and to evaluate your health status. 
 
 
5. Can I stop being in the study? 
 
You may leave the study at any time.  If you decide to stop participating in the study, 
there will be no penalty to you, and you will not lose any benefits to which you are 
otherwise entitled.  Your decision will not affect your future relationship with The Ohio 
State University. 
 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2022C0114 
IRB Approval date:  7/17/2023 
Version:  6/20/2023 
 
 
Page 6 of 14 
Form date: 
04/19/2021 
 
The study doctor may take you out of the study: 
• If your health changes and the study is no longer in your best interest 
• If new information becomes available 
• If you do not follow the study rules 
• If the study is stopped by the Sponsor or any of the regulatory bodies overseeing 
the study such as the IRB 
 
By signing this consent form, you give your permission for your information to be used 
and shared for the purposes of this study at any time in the future. This means your 
authorization for release of your health information has no expiration date. 
 
You may cancel your authorization at any time. You can do this by notifying your study 
doctor via in-person communication, phone, or sending a written notice:  
 
Aslam Ejaz, MD 
 
614-293-7171 
 
2050 Kenny Rd. 
 
7th Floor 
 
Columbus, Ohio 43221 
 
United States 
 
 
6. 
What risks, side effects or discomforts can I expect from being in the study? 
 
Side effects of Propofol: 
 
COMMON: 
 
• fast or slow heart rate 
• high or low blood pressure 
• injection site reactions (burning, stinging, or pain) 
• apnea (short stoppage of breathing) 
• rash 
• itching 
• blurred vision 
• confusion 
• headache 
• nervousness 
• pounding in the ears 
• problems with movement 
• sweating 
• unusual tiredness or weakness 
 
 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2022C0114 
IRB Approval date:  7/17/2023 
Version:  6/20/2023 
 
 
Page 7 of 14 
Form date: 
04/19/2021 
 
LESS COMMON: 
 
• bluish lips or skin 
• chest pain or discomfort 
• difficulty breathing 
• lightheadedness, dizziness, or fainting 
 
RARE: 
 
• anxiety 
• bleeding gums 
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling 
feelings 
• changes in vision 
• chills 
• cloudy urine 
• cough 
• coughing up blood 
• delirium or hallucinations 
• difficult urination 
• difficulty swallowing 
• dry eyes, mouth, nose, or throat 
• excessive muscle tone 
• eye pain 
• fever 
• flushing or redness of the face 
• general feeling of illness 
• hives, itching, skin rash 
• inability to move the eyes 
• increased blinking or spasms of the eyelid 
• increased menstrual flow or vaginal bleeding 
• increased watering of the mouth 
• irritability 
• joint pain or swelling 
• loss of appetite 
• mood or mental changes 
• muscle aches, cramps, or pains 
• muscle spasms or twitching 
• muscle stiffness, tension, or tightness 
• nausea or vomiting 
• nosebleeds 
• pain in the arms or legs 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2022C0114 
IRB Approval date:  7/17/2023 
Version:  6/20/2023 
 
 
Page 8 of 14 
Form date: 
04/19/2021 
 
• prolonged bleeding from cuts 
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue 
• red or dark brown urine 
• red or black, tarry stools 
• restlessness 
• shaking 
• sleepiness or unusual drowsiness 
• sore throat 
• sticking out of tongue 
• tightness in the chest 
• trembling 
• trouble sleeping 
• trouble speaking 
• uncontrolled twisting movements of the neck, trunk, arms, or legs 
• unusual facial expressions 
 
Blood Draw Risks: 
 
You may experience side effects of having your blood drawn. These include pain, 
swelling, bruising, tissue discoloration or scarring around the vein that is used to draw 
the blood sample. There is a possibility that some of these tissue changes and scarring 
could become permanent. There may be the risk of infection at the site where the needle 
is inserted into the vein. There is also the possibility that you may faint during or shortly 
after the needle is inserted. If you feel dizzy, you should tell someone and lie down to 
avoid falling and hurting yourself. These are the same risks that are associated with any 
blood drawing from your vein. All blood draws will be timed to routine blood work that 
you would normally undergo. 
 
 
7. 
What benefits can I expect from being in the study? 
 
You may or may not benefit directly from participating in the study. It is the 
researchers’ hope that information gained in this clinical study will help determine the 
best way to provide anesthesia for future patients undergoing abdominal cancer 
resection in order to decrease inflammation and lessen the effect on patients’ immune 
system so that they can better fight infections and other diseases. 
 
 
8. 
What other choices do I have if I do not take part in the study? 
 
You may choose not to participate without penalty or loss of benefits to which you are 
otherwise entitled. 
 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2022C0114 
IRB Approval date:  7/17/2023 
Version:  6/20/2023 
 
 
Page 9 of 14 
Form date: 
04/19/2021 
 
9. 
What are the costs of taking part in this study? 
 
You or your insurance company will not be billed for the cost of any tests or procedures 
that are required as part of this research study and are not the standard of care for your 
condition. 
 
You or your insurance company will still be responsible for the cost of routine 
medications, tests, and procedures that you would receive even if you were not in this 
research study. You or your insurance company will be billed for the costs of these 
routine tests and procedures in the usual manner. You will be responsible for any co-
payments, co-insurance and deductibles that are standard for your insurance coverage. 
You will be responsible for any charges not paid by your insurance company. 
 
Insurance companies will not pay for routine costs for people taking part in research 
studies. Before deciding to be in this research study, you should check with your 
insurance company to find out what they will pay. Being in this research study may lead 
to additional costs to you. In some cases, it is possible that your insurance company will 
not pay for these costs because you are in a research study 
 
The study doctor will explain to you which procedures, tests, and doctor visits are 
considered standard of care, including the propofol anesthesia and general lab tests 
needed for this study. 
 
 
10. Will I be paid for taking part in this study? 
 
You will not be paid for your participation in this study 
 
 
11. What happens if I am injured because I took part in this study? 
 
If you suffer an injury from participating in this study, you should notify the researcher 
or study doctor immediately, who will determine if you should obtain medical treatment 
at The Ohio State University Wexner Medical Center. 
 
The cost for this treatment will be billed to you or your medical or hospital insurance. 
The Ohio State University has no funds set aside for the payment of health care 
expenses for this study. 
 
 
12. What are my rights if I take part in this study? 
 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2022C0114 
IRB Approval date:  7/17/2023 
Version:  6/20/2023 
 
 
Page 10 of 14 
Form date: 
04/19/2021 
 
If you choose to participate in the study, you may discontinue participation at any time 
without penalty or loss of benefits.  By signing this form, you do not give up any 
personal legal rights you may have as a participant in this study. 
 
You will be provided with any new information that develops during the course of the 
research that may affect your decision whether or not to continue participation in the 
study. 
 
You may refuse to participate in this study without penalty or loss of benefits to which 
you are otherwise entitled.  
 
An Institutional Review Board responsible for human subjects research at The Ohio 
State University reviewed this research project and found it to be acceptable, according 
to applicable state and federal regulations and University policies designed to protect the 
rights and welfare of research participants. 
 
 
13. Will my de-identified information and bio-specimens be used or shared for 
future research? 
 
No. 
 
 
14. Will my study-related information be kept confidential? 
 
Efforts will be made to keep your study-related information confidential.  However, 
there may be circumstances where this information must be released.  For example, 
personal information regarding your participation in this study may be disclosed if 
required by state law. 
 
Also, your records may be reviewed by the following groups (as applicable to the 
research): 
• 
Office for Human Research Protections or other federal, state, or international 
regulatory agencies; 
• 
U.S. Food and Drug Administration; 
• 
The Ohio State University Institutional Review Board or Office of Responsible 
Research Practices; 
• 
The sponsor supporting the study, their agents or study monitors; and 
• 
Your insurance company (if charges are billed to insurance). 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. law.  This website will not include information that can identify you.  
At most, the website will include a summary of the results.  You can search the website 
at any time.  


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2022C0114 
IRB Approval date:  7/17/2023 
Version:  6/20/2023 
 
 
Page 11 of 14 
Form date: 
04/19/2021 
 
 
 
15. HIPAA AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR 
RESEARCH PURPOSES  
 
I. 
What information may be used and given to others? 
 
• Past and present medical records; 
• Research records; 
• Records about phone calls made as part of this research; 
• Records about your study visits; 
• Information that includes personal identifiers, such as your name, or a number 
associated with you as an individual; 
• Information gathered for this research about: 
Physical exams 
Laboratory, x-ray, and other test results 
The diagnosis and treatment of a mental health condition 
• Records about any anesthetic drug you received; 
 
II. Who may use and give out information about you? 
 
Researchers and study staff.   
 
III. Who might get this information? 
 
• The sponsor of this research.  “Sponsor” means any persons or companies that 
are: 
• working for or with the sponsor; or  
• owned by the sponsor. 
• Authorized Ohio State University staff not involved in the study may be aware 
that you are participating in a research study and have access to your 
information; 
• If this study is related to your medical care, your study-related information 
may be placed in your permanent hospital, clinic, or physician’s office record; 
 
IV. Your information may be given to: 
  
• The U.S. Food and Drug Administration (FDA), Department of Health and 
Human Services (DHHS) agencies, and other federal and state entities; 
• Governmental agencies in other countries; 
• Governmental agencies to whom certain diseases (reportable diseases) must be 
reported; and  


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2022C0114 
IRB Approval date:  7/17/2023 
Version:  6/20/2023 
 
 
Page 12 of 14 
Form date: 
04/19/2021 
 
• The Ohio State University units involved in managing and approving the 
research study including the Office of Research and the Office of Responsible 
Research Practices. 
 
V. 
Why will this information be used and/or given to others? 
 
• To do the research;  
• To study the results; and  
• To make sure that the research was done right.   
 
VI. When will my permission end? 
 
There is no date at which your permission ends. Your information will be used 
indefinitely. This is because the information used and created during the study may 
be analyzed for many years, and it is not possible to know when this will be 
complete. 
 
VII. May I withdraw or revoke (cancel) my permission? 
 
Yes. Your authorization will be good for the time period indicated above unless 
you change your mind and revoke it in writing. You may withdraw or take away 
your permission to use and disclose your health information at any time. You do 
this by sending written notice to the researchers. If you withdraw your permission, 
you will not be able to stay in this study. When you withdraw your permission, no 
new health information identifying you will be gathered after that date. 
Information that has already been gathered may still be used and given to others. 
 
VIII. What if I decide not to give permission to use and give out my health 
information? 
 
Then you will not be able to be in this research study and receive research-related 
treatment.  However, if you are being treated as a patient here, you will still be 
able to receive care. 
 
IX. Is my health information protected after it has been given to others? 
 
There is a risk that your information will be given to others without your 
permission. Any information that is shared may no longer be protected by federal 
privacy rules. 
 
 
 
 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2022C0114 
IRB Approval date:  7/17/2023 
Version:  6/20/2023 
 
 
Page 13 of 14 
Form date: 
04/19/2021 
 
X. 
May I review or copy my information? 
 
Signing this authorization also means that you may not be able to see or copy your 
study-related information until the study is completed.   
 
 
16. Who can answer my questions about the study? 
 
For study questions, concerns, or complaints, to withdraw consent and HIPAA 
authorization, or if you feel you have been harmed as a result of study participation, you 
may contact Dr. Aslam Ejaz at 614-293-7171 (office hours) or 614-293-8000 (24 hours) 
or Aslam.Ejaz@osumc.edu. 
 
For questions related to your privacy rights under HIPAA or related to this research 
authorization, please contact the HIPAA Privacy Officer at 614-293-6482 or by mail at:  
600 Ackerman Rd  
Room E2000  
Columbus, OH 43202 
 
For questions about your rights as a participant in this study or to discuss other study-
related concerns or complaints with someone who is not part of the research team, you 
may contact the Office of Responsible Research Practices at 1-800-678-6251. 
 
If you are injured as a result of participating in this study or for questions about a study-
related injury, you may contact Dr. Aslam Ejaz at 614-293-7171 (office hours) or 614-
293-8000 (24 hours) or Aslam.Ejaz@osumc.edu. 
 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2022C0114 
IRB Approval date:  7/17/2023 
Version:  6/20/2023 
 
 
Page 14 of 14 
Form date: 
04/19/2021 
 
Signing the consent form 
 
I have read (or someone has read to me) this form and I am aware that I am being asked to 
participate in a research study.  I have had the opportunity to ask questions and have had them 
answered to my satisfaction.  I voluntarily agree to participate in this study.  
 
I am not giving up any legal rights by signing this form.  I will be given a copy of this 
combined consent and HIPAA research authorization form. 
 
 
 
 
 
Printed name of participant 
 
Signature of participant 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
 
 
 
 
 
 
 
Printed name of person authorized to consent for 
participant (when applicable) 
 
Signature of person authorized to consent for participant  
(when applicable) 
 
 
 
 
 
AM/PM 
Relationship to the participant 
 
Date and time 
 
 
 
Investigator/Research Staff 
 
I have explained the research to the participant or his/her representative before requesting the 
signature(s) above.  There are no blanks in this document.  A copy of this form has been given 
to the participant or his/her representative. 
 
 
 
 
 
Printed name of person obtaining consent 
 
Signature of person obtaining consent 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
Witness(es) - May be left blank if not required by the IRB 
 
 
 
 
 
Printed name of witness 
 
Signature of witness 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
 
 
 
Printed name of witness 
 
Signature of witness 
 
 
 
 
 
 
AM/PM 
 
 
Date and time