Clinical trial NCT04226495
Conditions: Anesthesia
Sponsor: University of Nebraska
Start date: 2020-10-13; Completion date: 2021-10-28
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized single blind controlled clinical trial to test the benefit of sufentanil infusion over bolus dosing to reduce time to extubation and reduced length of ICU stay.

Detailed description:
This study will compare Sufentanil bolus vs infusion and analyze which has a faster extubation time in participants who undergo routine cardiac surgery. The hypothesis is that routine cardiac surgery patients receiving sufentanil infusion will have a lower sufentanil concentration at the end of surgery and have a shorter time to extubation than participants receiving sufentanil bolus dosing even with similar total doses of sufentanil. The intervention will be Sufentanil infusion during surgery and evaluations will include Sufentanil blood concentrations, ICU and hospital length of stay and re-intubation rate. We will follow up with the participants through their ICU stay (primary objective) and hospital length of stay (secondary objective).

Arms: arm 1: medication in scheduled doses (bolus) arm 2: medication in a slow trickle (infusion)
Interventions: intervention 1: Sufentanil Infusion intervention 2: Sufentanil Bolus
Intervention descriptions: intervention 1: Intra-operative sufentanil infusion intervention 2: Intra-operative sufentanil bolus

Protocol documents:
Prot_003.pdf: 
COVER SHEET 
Sufentanil Infusion vs. Sufentanil Bolus and Time to Extubation during Routine Cardiac Surgery 
NCT # 04226495 
September 30, 2020 


 
1 
Sufentanil Infusion vs. Sufentanil Bolus and Time to Extubation during Routine Cardiac Surgery 
Study Chairman or Principal Investigator: 
 
Jeffrey Songster, MD 
Assistant Professor, Department of Anesthesiology 
University of Nebraska Medical Center 
Supported by: 
 
Department of Anesthesiology 
University of Nebraska Medical Center 
 
Study Intervention Provided by: 
No support from pharmaceutical company or device manufacture. 
NCT Number: 
NCT # 04226495 
 
 
 
 
 
 
 
 
 
 
 


 
2 
PRÉCIS 
Study Title  
Sufentanil Infusion vs. Sufentanil Bolus and Time to Extubation during Routine Cardiac 
Surgery  
Hypothesis  
We hypothesize that routine cardiac surgery patients receiving sufentanil infusion will 
have a lower sufentanil concentration at the end of surgery and have a shorter time to 
extubation than patients receiving sufentanil bolus dosing even with similar total doses 
of sufentanil. 
Objectives  
Primary Outcome: Time the subject becomes extubated from stop data collection time 
point within the EMR. 
 
Secondary Outcome: Plasma Sufentanil concentrations, Sufentanil pharmacokinetics,  
24 hour post-operative pain scores, 24 hour opioid requirements in morphine equivalents, 
vasopressors and inotropes usage, ICU length of stay, Hospital length of stay, early re-
intubation rate. 
Design and Outcomes   
Randomized single blind controlled clinical trial to test the benefit of sufentanil infusion 
over bolus dosing to reduce time to extubation and reduced length of ICU stay. 
 
Interventions and Duration: 
Intervention period: intra-operative sufentanil infusion vs intermittent bolus dosing the 
intervention will stop at the stop data collection time point within the operating room.  
 
Post Intervention: Multiple lab draws at various time points to assess sufentanil 
concentrations and pharmacokinetics, we will follow pain scores and opioid requirements 
for 24 hours post intervention, we will follow the patient until discharge from the hospital 
for ICU length of stay and hospital length of stay. No further follow up after discharge. 
We anticipate a 24-48 hour ICU length of stay and a 5-7 day hospital length of stay. 
  
Sample Size and Population  
Adults between ages 19 and 80 with reasonable cardiac and pulmonary function 
presenting for routine cardiac surgery including coronary artery bypass graft and aortic 
valve replacement who qualify for “fast track extubation”. Based on estimates for time to 
extubation for our study population on sufentanil bolus dosing where we have an average 
time to extubation of 190.5 minutes (SD = 99 min) and assuming 80% power and 
statistical significance alpha level of 0.05, our power analysis suggests that we would 


 
3 
need to recruit at least 43 subjects into each intervention group for a total of 86 subjects 
giving the ability to detect a 60 min difference in time to extubation between groups. We 
plan on inflating this number to at least 100 subjects with approximately 50 subjects in 
each arm to allow for potential minimal losses in evaluable patients associated with 
unforeseen attrition related to exclusion criteria and censoring due to death or severely  
 

ICF_001.pdf: 
PT NAME:   
MR#: 
CONSENT FORM
IRB PROTOCOL # 520-20-FB
  Page 1 of 8
CONSENT FORM
Title of this Research Study
Sufentanil Infusion vs Sufentanil Bolus and Time to Extubation during Routine
Cardiac Surgery
Invitation and Summary
You are invited to be in this research study. Taking part in this research is voluntary.
You do not have to take part. For the purposes of this document: "You" can refer to:
Yourself
The person for whom you are the Legally Authorized Representative (LAR)
Your child under the age of 19.
"Organization" can refer to: University of Nebraska Medical Center (UNMC),
Nebraska Medicine (NM), University of Nebraska at Omaha (UNO) or Children's
Hospital & Medical Center (CH&MC).
Here is a summary of the purpose, methods, risks, benefits, and alternatives, to help
you decide whether or not to take part in the research.
The purpose of the study is to compare the way we give an opioid pain medication
(Sufentanil).
We typically give you this pain medication in the form of multiple larger doses pushed
through your blood, and we are wanting to see if by giving this pain medication
(Sufentanil) in a slow trickle fashion, through your blood, you would be able to have
the breathing tube removed faster.
We aren't sure if one way of giving the medication will allow us to remove your
breathing tube faster, this is why we are doing the study.
In this study, we will also draw your blood, but this will be done from an existing small
tube that will be placed before surgery. This is similar to an IV, commonly used to
draw your blood.
We will be drawing your blood 8 times in order to look at how much of the pain
medication (Sufentanil) you have in your blood. The total amount of blood we will be
collecting is 48mLs, which is about three Tablespoons. For your surgery, three
tablespoons of blood taken is a common amount. We will then monitor how fast your
breathing tube is removed, how long you stay in the intensive care unit (ICU) and
IRBVersion 4
  IRB
  Approved 06/17/2021
  Valid until 06/17/2022


PT NAME:   
MR#: 
CONSENT FORM
IRB PROTOCOL # 520-20-FB
  Page 2 of 8
how long you stay in the hospital.
The possible risks of this study are loss of confidentiality, loss of blood and risks with
the pain medication given. Each risk is full explained in the 'What are the Possible
Risks of Being in this Study' section.
Potential benefits to you may be less pain and faster time to having the breathing
tube removed, which may lead to less time spent in the intensive care unit and less
time spent in the hospital.
Instead of being in this research study, you can choose not to take part.
Why are you being asked to be in this research study?
You are being asked to participate in this study because you are between the ages of
19 and 80 years old, and you are scheduled to have a surgery to correct an issue
with your heart. Up to 150 people may participate in this study.
What is the reason for doing this research study?
We are doing this study because we want to see if changing the way we give pain
medication makes a difference in the quickness of recovery.
What will be done during this research study?
In this study, you will be assigned to one of two groups. One group will receive the
medication in scheduled doses (bolus). The other group will receive the medication in
a slow trickle fashion in your vein (infusion). This will happen like a flip of a coin,
50/50 chance of which group you will be assigned. We will not know ahead of time
which group you will be in. You will also have your blood drawn so that we can
evaluation how much of the medication is in your body. The sample(s) we collect will
not be used for other research studies by us, or by any other investigator after this
research is over. If you decide to participate, you are agreeing to having your blood
drawn an additional eight times, collected about three tablespoons of blood,
throughout your hospital stay, for research only. By participating in the research
study, you are also agreeing to having the pain medication you receiving during your
surgery, while you are asleep, given to you in either a scheduled push of medication
or in a slow trickle fashion. We will also be drawing your blood 8 times in order to look
at how much of the pain medication (Sufentanil) you have in your blood. The total
amount of blood we will be collecting is 48mLs, which is about three Tablespoons.
What are the possible risks of being in this research study?
IRBVersion 4
  IRB
  Approved 06/17/2021
  Valid until 06/17/2022


PT NAME:   
MR#: 
CONSENT FORM
IRB PROTOCOL # 520-20-FB
  Page 3 of 8
The risks of the study include someone finding out who you are and the loss of blood.
Only people directly involved in your care are listed on the study, in order to minimize
the risk of someone finding out you are in a research study. We will take as small
amount of blood as needed. There are additional risks of the pain medication you will
be given during your surgery, whether or not you participate in the study. The
potential risks of this pain medication are nausea, slow breathing, missing a breath,
slow heart beat, and low blood pressure. Rarely, your heart may start to beat out of
order, your chest muscles may become tight making it hard to breath. You may also
experience of feeling of uneasy, sweating, shaking, fast heart rate, fever, vomiting or
diarrhea. You will be monitored by an Anesthesiologist doctor throughout your entire
procedure for any of these risks. Possible risks of being assigned to infusion group,
versus standard medical care, could include prolonged sedation effect or delayed
wakening from anesthesia, more pain after surgery, lower blood pressure and heart
rate during surgery with increased need of supportive medications for blood pressure
and heart rate.
What are the possible benefits to you?
Potential benefits to you include: faster time to have the breathing tube removed,
which often leads to less time spent in the intensive care unit and less time spent in
the hospital. You may also experience less pain.
What are the possible benefits to other people?
The same benefits that are possible to you may be possible to other people in the
future. Future patients may experience less pain, less time with the breathing tube
and less time spent in the hospital after their surgery.
What are the alternatives to being in this research study?
Instead of being in this research study, you can choose not to take part.
What will being in this research study cost you?
You will have to pay any insurance deductibles and co-payments. If you want to
speak with someone about your insurance, just tell us.
Will you be paid for being in this research study?
You will not be paid to be in this research study.
Who is paying for this research?
This research is being paid for by the Department of Anesthesiology, of the University
of Nebraska Medical Center.
IRBVersion 4
  IRB
  Approved 06/17/2021
  Valid until 06/17/2022


PT NAME:   
MR#: 
CONSENT FORM
IRB PROTOCOL # 520-20-FB
  Page 4 of 8
What should you do if you are injured or have a medical problem during this
research study?
Your health and safety is our main concern. If you are injured or have a medical
problem because of this study call someone listed at the end of this consent form.
You can get emergency medical treatment at Nebraska Medicine. You can also go to
your doctor, the nearest emergency room or call 9-1-1.
We have no plans to pay for your treatment or give you any other money or
compensation. Your insurance may pay. If they do not you will have to pay.
Signing this consent form does not mean you have given up any of your legal rights.
How will information about you be protected?
In the course of this research we may collect information about you. This can be
things that could be used to find out who you are (like your name, phone number,
birthdate, address). We call this "identifiable private information". We will keep this
information as confidential as possible.
The information will not be used for other research by us, or by any other researcher.
Who can see information about you?
We also will get medical information about you (like medical record number, medical
history, or the results of physical exams, blood tests, x-rays or other medical or
research procedures). We call this "protected health information" or PHI. PHI is
protected by a law called the HIPAA Privacy Rule. We will collect the smallest
amount of PHI that we can. We will keep your PHI as confidential as possible.
By signing this consent form, you are letting us (the researchers listed on this
consent form and other people involved in this research at the Organization) have
access to your PHI. Your PHI will be used only for the purposes described in the
section "What is the reason for doing this research study?"
You can change your mind and tell us to stop collecting your PHI for use in this
research at any time by writing to the principal investigator. We can still use the PHI
we have already collected. If you tell us to stop collecting your PHI, you will have to
stop being in this research.
We may share your PHI with other groups listed below:
The UNMC Institutional Review Board (IRB)
Institutional officials designated by the UNMC IRB
The HHS Office for Human Research Protections (OHRP)
IRBVersion 4
  IRB
  Approved 06/17/2021
  Valid until 06/17/2022


PT NAME:   
MR#: 
CONSENT FORM
IRB PROTOCOL # 520-20-FB
  Page 5 of 8
You are letting us use and share your PHI for as long as the research is going on.
How will results of the research be made available to you during and after the
study is finished?
In most cases, the results of the research can be made available to you when the
study is completed, and all the results are analyzed by the investigator or the sponsor
of the research. The information from this study may be published in scientific
journals or presented at scientific meetings, but your identity will be kept strictly
confidential.
If you want the results of the study, contact the Principal Investigator at the phone
number given at the end of this form or by writing to the Principal Investigator at the
following address:
Jeffrey Songster, MD
University of Nebraska Medical Center
42nd & Emile St
Omaha, NE. 68198
A description of the clinical trial will be available on 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 this website
at any time.
What will happen if you decide not to be in this research study?
You can decide not to be in this research study. Deciding not to be in this research
will not affect your medical care or your relationship with the investigator or the
organization. Your doctor will still take care of you and you will not lose any benefits
to which you are entitled.
What will happen if you decide to stop participating once you start?
You can stop being in this research (withdraw) at any time. Just call the researcher or
any research staff. If you stop being in the research study it will not affect your care
or your relationship with the investigator or the organization. You will not lose any
benefits to which you are entitled.
You may be taken off the study if you do not follow instructions of the investigator or
the research team. You may also be taken off the study if the investigator does not
feel it is safe for you to continue with the study. Any research data we have already
collected can still be used in the research.
IRBVersion 4
  IRB
  Approved 06/17/2021
  Valid until 06/17/2022


PT NAME:   
MR#: 
CONSENT FORM
IRB PROTOCOL # 520-20-FB
  Page 6 of 8
Will you be given any important information during the study?
We will tell you right away if we get any new information that might make you change
your mind about being in the study.
What should you do if you have any questions about the study?
We gave you a copy of "What Do I Need to Know Before Being in a Research
Study?"
If you ever have any questions about this study, call the Principal Investigator or
anyone else listed on this consent form.
What are your rights as a research participant?
You have rights as a research subject. These rights have been explained in this
consent form and in The Rights of Research Subjects that you have been given. If
you have any questions concerning your rights, or want to discuss problems,
concerns, obtain information or offer input, or make a complaint about the research,
you can contact any of the following:
The investigator or other study personnel
Institutional Review Board (IRB)
Telephone: (402) 559-6463
Email: IRBORA@unmc.edu
Mail: UNMC Institutional Review Board, 987830 Nebraska Medical
Center, Omaha, NE 68198-7830
Research Subject Advocate
Telephone: (402) 559-6941
Email: unmcrsa@unmc.edu
Documentation of informed consent
You are deciding whether to be in this research study. Signing means that:
You have read and understood this consent form.
You have had the consent form explained to you.
You have been given a copy of The Rights of Research Subjects
You have had your questions answered.
You have decided to be in the research study.
You have been told you can talk to one of the researchers listed below on this
consent form if you have any questions during the study.
You will be given a signed and dated copy of this consent form to keep.
IRBVersion 4
  IRB
  Approved 06/17/2021
  Valid until 06/17/2022


PT NAME:   
MR#: 
CONSENT FORM
IRB PROTOCOL # 520-20-FB
  Page 7 of 8
Signature of Subject____________________________Date___________
My signature certifies that all the elements of informed consent described on this
consent form have been explained fully to the subject. In my judgment, the subject
possesses the legal capacity to give informed consent to participate in this research
and is voluntarily and knowingly giving informed consent to participate
Signature 
of 
Person 
Obtaining 
Consent____________________________
Date___________
Authorized Study Personnel
Principal
* Songster, Jeffrey
phone: 402-559-4081
alt #: 402-559-4081
degree: MD
 
 
Secondary
* Adams, Austin
phone: 402-559-4081
alt #: 402-559-4081
degree: MD
* Alex, Brandon
phone: 402-559-7405
alt #: 402-559-4081
degree: MD
 
* Aron, Rebecca
phone: 402-559-4081
alt #: 402-559-4081
degree: MD
* Bartels, Karsten
phone: 402-559-4081
alt #: 402-559-4081
degree: MD PhD MBA
 
* Brakke, Tara
phone: 402-559-4081
alt #: 402-559-4081
degree: MD
* Brannan, Stephen
phone: 402-559-4081
alt #: 402-449-4081
degree: MD
 
* Chacon, Martha (Megan)
phone: 402-559-4081
alt #: 402-559-4081
degree: MD
* Duhachek-Stapelman, Amy
phone: 402-559-5782
alt #: 402-559-4081
degree: MD
 
IRBVersion 4
  IRB
  Approved 06/17/2021
  Valid until 06/17/2022


PT NAME:   
MR#: 
CONSENT FORM
IRB PROTOCOL # 520-20-FB
  Page 8 of 8
* Ghaly, Tammer
phone: 402-559-7370
alt #: 402-559-4081
degree: MD
* Goergen, Katie
phone: 402-559-4081
alt #: 402-559-4081
degree: MD
 
* Koch, Kristina
phone: 402-559-7370
alt #: 402-559-4081
degree: MD
* Lorenzen, Kristi
phone: 402-559-4081
alt #: 402-559-4081
degree: MD
 
* Maresch, Andrew
phone: 402-559-4081
alt #: 402-559-4081
degree: MD
* Markin, Nicholas (Nick)
phone: 402-559-4081
alt #: 402-559-4081
degree: MD
 
* Roberts, Ellen
phone: 402-559-4081
alt #: 402-559-4081
degree: MD
* Schulte, Thomas
phone: 402-559-4081
alt #: 402-559-4081
degree: MD
 
* Shillcutt, Sasha
phone: 402-559-3685
alt #: 402-559-4081
degree: MD
 
IRBVersion 4
  IRB
  Approved 06/17/2021
  Valid until 06/17/2022


Institutional Review Board (IRB)
What Do I Need To Know
Before Being In A Research Study?
You have been invited to be in a research study. Research studies are also called
"clinical trials" or "protocols." Research is an organized plan designed to get new
knowledge about a disease or the normal function of the body. The people who are in
the research are called research subjects. The investigator is the person who is
running the research study. You will get information from the investigator and the
research team, and then you will be asked to give your consent to be in the
research.
This sheet will help you think of questions to ask the investigator or his/her
staff. You should know all these answers before you decide about being in the
research.
What is the purpose of the research? Why is the investigator doing the research?
What are the risks of the research? What bad things could happen?
What are the possible benefits of the research? How might this help me?
How is this research different than the care or treatment I would get if I wasnt in
the research? Are there other treatments I could get?
Does everyone in this research study get the same treatment?
Will being in the research cost me anything extra?
Do I have to be in this research study? Will the doctor still take care of me if I say no?
Can I stop being in the research once Ive started? How?
Who will look at my records?
How do I reach the investigator if I have more questions?
Who do I call if I have questions about being a research subject?
Make sure all your questions are answered before you decide whether or not to
be in this research.
Academic Research & Services Building 3000  /  987830 Nebraska Medical Center  /  Omaha NE  68198-7830
402-559-6463  /  FAX 402-559-3300 / Email: irbora@unmc.edu  /   http://www.unmc.edu/irb


Institutional Review Board (IRB)
THE RIGHTS OF RESEARCH SUBJECTS
AS A RESEARCH SUBJECT YOU HAVE THE RIGHT 
 to be told everything you need to know about the research before you are
asked to decide whether or not to take part in the research study. The research
will be explained to you in a way that assures you understand enough to decide
whether or not to take part.
 to freely decide whether or not to take part in the research.
 to decide not to be in the research, or to stop participating in the research at
any time. This will not affect your medical care or your relationship with the
investigator or the Nebraska Medical Center. Your doctor will still take care of you.
 to ask questions about the research at any time. The investigator will answer
your questions honestly and completely.
 to know that your safety and welfare will always come first. The investigator will
display the highest possible degree of skill and care throughout this research. Any
risks or discomforts will be minimized as much as possible.
 to privacy and confidentiality. The investigator will treat information about you
carefully, and will respect your privacy.
... to keep all the legal rights you have now. You are not giving up any of your
legal rights by taking part in this research study.
 to be treated with dignity and respect at all times
The Institutional Review Board is responsible for assuring that your rights and
welfare are protected. If you have any questions about your rights, contact the
Institutional Review Board at (402) 559-6463.
Academic Research & Services Building 3000  /  987830 Nebraska Medical Center  /  Omaha NE  68198-7830
402-559-6463  /  FAX 402-559-3300 / Email: irbora@unmc.edu  /   http://www.unmc.edu/irb
Powered by TCPDF (www.tcpdf.org)