Conditions: Spinal Fusion
Keywords: motor evoked potentials
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 7
Healthy volunteers: no

Brief summary:
This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on motor evoked potentials during spine surgery

Detailed description:
This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on suitability of motor evoked potentials for intraoperative monitoring during spine surgery

Arms:
arm 1: Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min arm 2: Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min

Interventions: intervention 1: Dexmedetomidine
Intervention descriptions: intervention 1: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.

Protocol document:
ICF_000.pdf: 
 
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IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
11/28/2017 Thru 11/27/2018 
HOSPITAL FOR SPECIAL SURGERY 
535 East 70th Street  
New York, NY 10021 
 
 
INFORMED CONSENT TO PARTICIPATE IN RESEARCH 
 
TITLE: The effect of dexmedetomidine dose on motor evoked potentials during spine surgery: A 
randomized, single-blind trial. 
 
PROTOCOL NO.: 
 
SPONSOR:  
 
INVESTIGATOR: Ronald Emerson, M.D. 
 
SITE(S): HSS operating room, Belaire, 5th floor 
 
STUDY-RELATED PHONE NUMBER(S): 774-2942 
 
IRB #:2017-1304 
 
You are being asked to take part in a research study conducted by Hospital for Special Surgery 
(HSS).  You are being asked to participate in this study because you are having surgery to correct 
curvature of the spine.    
 
You will still be responsible for the cost of your medical care just as you would be if you 
were not part of this study.  For example, any co-pays, deductibles, and co-insurance 
associated with your medical care. 
 
This document provides you with information about this study.  After reading this document, any 
questions you may have will be answered.  You may take home a copy of this document to 
consider or discuss with family and friends before making your decision.  
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site 
will include a summary of the results. You can search this Web site at any time. 
  
1.  WHY IS THIS STUDY BEING DONE? 
 
The purpose of this study is to determine the effect of dexmedetomidine, an anesthetic, on testing 
that we do during spine surgery to monitor the spinal cord.  The testing is called motor evoked 
potential monitoring, and it monitors the parts of the spinal cord that are important to movement 
of the arms and legs. All anesthetics interfere to some degree with this monitoring.  We are 
attempting to develop the best anesthetic mixture to provide safe and effective general anesthesia 


 
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while maximizing our ability to monitor the spinal cord.  The addition of intravenous 
dexmedetomidine to the general anesthetic may help us to improve safety, by reducing the use of 
other agents and making it possible to wake up faster once the surgery is over.  
Dexmedetomidine is not new.  It was approved by the FDA in 1999, and is used routinely at 
HSS.  Your participation in this study will take place during your operation. 
 
During spinal surgery, it is normal for your anesthesiologist to replace fluids that are lost from 
your circulation during the surgery. We will use a device called the NICOM monitor to measure 
the output of your heart, which is related to the amount of fluid in your circulation.  The NICOM 
monitor does this using four small pads that stick to your chest.  We will analyze your motor 
evoked potential monitoring to see if the small changes that we often see during spinal surgery 
are related to the amount of fluid in your circulation.  We will do this to see if motor evoked 
potential monitoring is helpful for guiding replacement of fluids. 
 
 
2.  WHAT WILL YOUR PARTICIPATION REQUIRE?   
 
If you decide to be in this study, the following research procedures will be performed: you will 
receive one of two different anesthetic treatments during surgery, both of which are standard of 
care.  Regardless of the treatment used, you will not feel any pain during surgery. One treatment 
will include intravenous propofol and a lower dose of dexmedetomidine.  The other will include 
lower dose of intravenous propofol and a higher dose of dexmedetomidine.   The treatment to be 
administered will be determined randomly – rather like the flip of a coin.   Only the 
anesthesiologist will know the anesthetic treatment being used; other members of operating room 
team, including the surgeon, will not know.  
 
If you decide to be in this study, we will also use a NICOM monitor. 
 
It is not known which anesthetic treatment is superior and will be most benefit to you.  It is 
hoped the knowledge gained will benefit others in the future. 
 
You and/or your insurance will be responsible for any costs of all procedures performed that are 
standard of care, that is, care that you would receive even if you were not in this study. 
 
A total of 68 subjects will participate in this study at HSS.   
 
Your participation will be limited to your surgery.  There will be no extra visits. 
 
3.  WHAT ADVERSE (BAD) EFFECTS CAN HAPPEN FROM BEING IN THE STUDY?  
WHAT RISKS ARE KNOWN ABOUT THE STUDY DRUG/STUDY DEVICE? 
 
The known effects, discomforts and foreseeable risks of physical, psychological, sociological, or 
other harm which you may reasonably expect to occur from being in this study is the risk of 
awareness, i.e. not being fully asleep, during surgery.   If this happens, it will not be possible for 
you to report this during surgery.   However, the risk of awareness should be no greater during 


 
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Hospital for Special Surgery Institutional 
Review Board Approval 
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this study than during other operations for curvature of the spine, which is routinely performed 
using mostly or total intravenous anesthesia.    
 
In order to reduce the likelihood of awareness, you will also receive intravenous diazepam 
(Valium) during surgery. 
 
Motor evoked potential monitoring entails a small risk of tongue bite, but that risk is not altered 
by participation in this study since the will be used as a necessary part of your surgery. 
 
The use of the NICOM monitor uses four small stick-on chest pads, and does not add any risks. 
 
Participation in this research involves the potential risk of a breach of confidentiality to your 
stored health information.  HSS tries to minimize those risks by (i) removing some direct 
identifiers from stored information [(i.e., names, social security numbers, medical record 
numbers; (ii) securing, in a separate location, and limiting access to information that would 
identify you; and (iii) limiting access to information stored to HSS investigators. 
 
There may be risks or side effects that are unknown at this time.  
 
Your condition may not get better from being in this study. 
 
 
4.  WHAT BENEFIT CAN YOU EXPECT?  
 
This study is comparing two standard of care anesthetic treatments to determine which may be 
more effective.  The knowledge gained from this study may benefit others in the future.  There is 
no direct benefit from participating in this research. 
 
 
5.  COST  
 
There will be no cost to you for participation in this study because this study does not involve 
any additional visits, tests, or procedures.   
 
You will still be responsible for the cost of your medical care, and for any co-pays, deductibles, 
and co-insurance associated with your medical care, just as you would be if you were not part of 
this study. 
 
HSS is committed to providing financial assistance when financially warranted and consistent 
with its resources, regardless of age, gender, religion, race or sexual orientation.  So if you do not 
have health insurance, or if your health insurance does not pay for your medical care, you may 
seek financial assistance from HSS.  Eligibility determinations are made on a case-by-case basis 
in accordance with HSS’s financial assistance policy.  You will be responsible for any costs not 
covered by financial assistance, which could be all of the costs (if HSS determines that you are 
not eligible for financial assistance) or some of the costs (if financial assistance awarded by HSS 


 
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does not cover all of the costs). For more information about the Financial Assistance Program or 
to request a Financial Assistance Application call (212) 606-1505 to speak with a Financial 
Assistance Counselor or you can visit the following site:  http://www.hss.edu/patient-financial-
assistance-notice.asp. 
 
 
6.  PREGNANCY  
 
Due to inherent risks, HSS policy prevents women who are pregnant or nursing a child from 
receiving the type of surgery needed to qualify for this research study.  So, if you are currently 
pregnant or nursing a child, you may not participate in this study. 
 
 
7.  PAYMENT FOR PARTICIPATION 
 
You WILL NOT be paid for your participation in this study.  
 
8.  COMMERCIAL ISSUES:  YOUR RIGHTS IN THE RESULTS OF THE STUDY 
 
There are no plans to compensate you for the use of the findings of this study, or any of the 
information or biologic materials (such as blood or tissue) collected from you during the study, 
even if they are used to develop or make a commercial product (such as a drug, device, biologic 
substance, or test).   
 
9.  ALTERNATIVES:  WHAT OTHER TREATMENT IS AVAILABLE IF YOU DON’T 
WANT TO BE IN THE STUDY?  
 
You do not have to participate in this study to receive treatment for your condition.   
 
If you decide not to be part of this study, you will still receive MEP monitoring during surgery.  
You will receive anesthesia as decided by your attending anesthesiologist, which could include 
one of the two treatments that is being used in this study. 
 
You should ask the study doctor about other alternative treatments that may be available for your 
condition.  
 
 
10.  WHO WILL BE ABLE TO SEE YOUR RECORDS AND PERSONAL 
INFORMATION AND KNOW THAT YOU ARE IN THE STUDY? 
 
Federal regulations give you certain rights related to your health information.  These include the 
right to know who will be able to see your information and why they will be able to see it.  The 
study doctor must obtain your authorization (permission) to use or give out any health 
information that might identify you.  
 


 
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What information may be used or given to others?   
 
If you choose to be in the study, the study doctor will get personal information about you.  The 
information might identify you.  The study doctor may also get information about your health 
including:  
 
• Medical and research records 
• Records about surgery 
• Records of physical exams 
• Records about phone calls 
• Laboratory, x-ray, and other test results 
 
Who may use, disclose, or receive my information? 
  
The following person(s) class(es) of persons, and/or organization(s) may use, disclose, or receive 
my information: 
 
• The Principal Investigator and other Investigators for this study, including your study 
doctor. 
• The research coordinator, research nurses, and other members of the HSS research team 
working on this study. 
• Every research site for this study, including Hospital for Special Surgery and its affiliates, 
New York-Presbyterian Hospital, and Memorial Sloan-Kettering Cancer Center. This 
includes the research staff and medical staff at each institution. 
• The Patient Advocate or Research Ombudsman at these institutions. 
• Staff members of HSS responsible for administering clinical trials and other research 
activities 
• Any laboratories and other individuals and organizations that analyze your health 
information for this study. 
• Any health care provider that you have used in the past or may use up to the time this study 
ends. 
• The sponsor of this study. “Sponsor” includes any persons or companies that are working 
for or with the sponsor, or are owned by the sponsor.  
• Any Contract Research Organization (CRO) the sponsor may use. (A CRO is an 
independent entity with which a research sponsor contracts to oversee and facilitate various 
aspects of the clinical research process on the research sponsor’s behalf.) 
• The United States Food and Drug Administration (FDA), the federal Office for Human 
Research Protections (OHRP), any federal agency that provides support for this study, and 
any federal, state, or local agency responsible for overseeing HSS, the study doctor, or any 
other member of the HSS research team involved in this study. 
• The members and staff of the affiliated Institutional Review Boards (IRBs) at HSS, New 
York-Presbyterian Hospital, and Memorial Sloan-Kettering Cancer Center.  An IRB is a 
committee of health care providers, community representatives, and others that initially 


 
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approves and periodically reviews biomedical and behavioral research that involves human 
subjects in order to protect the rights, safety and welfare of study participants. 
• Data Safety Monitoring Boards and others authorized to monitor the conduct of this study 
for safety or quality assurance, for example a Clinical Events Committee. 
 
Why will this information be used and/or given to others?   
 
Your health information may be given to others to carry out this study.  The sponsor will analyze 
and evaluate the results of this study.  People working for the sponsor also visit HSS and other 
research sites to make sure this study is being done correctly.   
 
Your health information may be given to the FDA.  It may also be given to governmental 
agencies in other countries. This is done so the sponsor can get approval to market new products 
resulting from this study.  Your information may also be used to meet the reporting requirements 
of governmental agencies.  
 
The results of this study may be published in scientific journals or presented at medical meetings, 
but your identity will not be disclosed.   
 
What if I decide not to give permission to use and give out my health information?   
 
By signing this informed consent form, you are giving permission to use and give out your health 
information as described above.  If you refuse to give permission, you cannot be in this study.  
 
May I review or copy the information obtained from me or created about me? 
   
You have the right, in accordance with Hospital policy and applicable law, to review and copy 
your health information that is created or obtained in the course of this study.  However, if you 
decide to be in this study and sign this informed consent form, you will not be able to look at or 
copy your information until after the study is completed if doing so would impact the validity of 
the study (for example, if the study is “blinded” so that during the study you will not know what 
treatment or other intervention you are receiving). 
 
May I revoke (take back) my permission?  
 
Yes. Your permission will never expire unless you revoke it.  To revoke your permission, you 
must write to the study doctor at Hospital for Special Surgery, 535 East 70th Street, New York, 
NY 10021. 
 
You may revoke your permission to use and disclose your health information at any time.  If you 
revoke your permission, you cannot continue to participate in this study.   
 
After you revoke your permission, no new health information that might identify you will be 
gathered. Information that has already been gathered may still be used and given to others. This 
would be done if the information is needed for this study to be reliable.   


 
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Is my health information protected after it has been given to others?  
 
Some persons who receive your health information may not be required to protect it, and they 
may share your information with others without your permission, if permitted by laws governing 
them.  Therefore, there is a risk that your information will be released to others without your 
permission. 
 
11.  CONFLICT OF INTEREST NOTIFICATION 
  
HSS is concerned about possible conflicts of interest in research, and has policies that require all 
investigators and senior research staff to report to HSS significant financial interests (such as 
stock ownership, royalty payments, and consulting agreements) and relationships (such as 
membership on a scientific advisory board) that are related to their research studies.  When an 
investigator reports a significant financial interest or relationship that relates to one of his/her 
studies, HSS’s Conflict of Interest Committee for Research reviews the information to evaluate 
the risk that the interest or relationship might influence how the investigator conducts the study 
or interprets the results of the study.  HSS may also take steps to minimize that risk.   
 
 
The Conflict of Interest Committee for Research has determined that there are no 
conflicts of interest associated with this study. 
 
 
12.  VOLUNTARY PARTICIPATION/WITHDRAWAL 
 
Your decision to take part in this study is completely voluntary.  You are free to choose not to 
take part in the study and may change your mind and withdraw at any time.  Your relationship 
with physicians at HSS and your medical care at HSS, now or in the future, will not be affected 
in any way if you withdraw or refuse to participate.  You will not lose any benefits to which you 
are otherwise entitled. 
 
The study doctor and/or the sponsor may terminate your participation in this study at any time 
without your consent if, in their judgment, it is inadvisable for you to continue.   
 
13.  COMPENSATION FOR INJURY 
 
If you are injured as a result of participating in this study, the study doctor, other members of the 
research team, or other HSS professional medical staff will provide you with emergency medical 
treatment (or arrange to have such treatment provided to you), and will assist you in obtaining 
appropriate follow-up medical treatment. However, there is no plan to routinely provide 
compensation for additional medical care or other costs. 
 


 
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Your health insurance may or may not pay for treatment of injuries as a result of your 
participation in this study.  
 
14.   SOURCE OF FUNDING  
 
Funding for this study will be provided by the HSS Department of Neurology. 
 
 
15.  QUESTIONS   
 
If you have any additional questions later on, or if you wish to report a medical problem that may 
be related to this study, Dr. Emerson can be reached at 212-774-2742 during office hours and at 
212-606-1050 after business hours.  
 
If you have any questions about your rights as a participant in this study or any questions about 
your participation that you would like to ask an institutional representative who is not part of this 
study, you can call the Manager of the HSS Institutional Review Board at (212) 774-7154.  
 
If you would like to have more information about the Hospital’s financial disclosure review 
process in general, or in regard to this study, you may contact the Hospital’s Office of Legal 
Affairs at (212) 606-1592.   You may also ask the Hospital’s patient advocate at (212) 774-2403, 
to arrange for you to have this information. 
 
Do not sign this consent form unless you have had a chance to ask questions and have received 
satisfactory answers to all of your questions.  


 
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Agreement to Participate: Witnessing and Signature 
 
To be in this study, you or your legal representative must sign the next page of this informed 
consent form. By signing the next page, you are voluntarily agreeing to be in this study at HSS. 
 
Before signing, you should be sure of the following: 
 
• You have read all of the information in this “Informed Consent to Participate in Research” 
form (or had it read to you).  
• You have discussed the implications of your being in this study with your doctor, your 
study doctor and/or the study coordinator.  
• You have had the chance to ask questions about this study. 
• You received answers to your questions. 
• If you did not understand any of the answers, you asked the study doctor or the study 
coordinator to explain them to you. 
• The information given to you is based on what is now known about the study drug(s), 
device(s), or procedure(s).  There may be other risks or complications that are not known at 
this time. 
• You have had time to think about the information and decide whether or not to be in the 
study. 
 
Please check one of the following: 
 
   I AM NOT in another research study at this time. 
 
   I AM in another research study at this time. 


 
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If you decide to be in this study: 
 
• You are expected to follow the study procedures. 
• You are expected to provide the information needed by the study doctor, the study 
coordinator, nurses, or other staff members for the study. 
• You will be told in a timely manner of any significant new information that may affect 
your willingness to stay in the study. 
• You may freely choose to stop being in the study at any time. 
 
By signing below, you are voluntarily agreeing to be in this study. 
 
You must be given a signed copy of this informed consent form to keep for yourself. 
 
 
 
______________________________________ 
_______________________________________ 
Print Name of Participant  
 
 
Signature of Participant 
 
            Date 
 
______________________________________           ______________________________________ 
Print Name of Parent/Legal Guardian (if applicable)1 
Signature of Parent/Legal Guardian  
Date 
 
____________________________________ 
_______________________________________ 
Print Name of Person Obtaining Consent 
 
Signature of Person Obtaining Consent       Date 
 
 
 
_____________________________________  
As an HSS representative, please sign here to indicate that you have given a signed copy of this informed consent 
form to the participant 
 
 
NOTE TO INVESTIGATORS: 
• 
THE ORIGINAL OF THIS INFORMED CONSENT FORM MUST BE PLACED IN THE 
PARTICIPANT’S STUDY FILE. 
• 
A SIGNED COPY OF THIS INFORMED CONSENT FORM MUST BE GIVEN TO THE 
PARTICIPANT. 
• 
A COPY OF THE INFORMED CONSENT FORM MUST BE PLACED IN THE 
PARTICIPANT’S HOSPITAL MEDICAL RECORD IF THE PARTICIPANT IS (OR WILL 
BE) HOSPITALIZED AT ANY TIME DURING THE STUDY. 
 
1 The parent or legal guardian of a child participant should sign this form on behalf of the child.  The signature of 
one parent is sufficient when the research is of minimal risk to the child, or when the research presents the prospect 
of direct benefit to the child.  The signature of both parents is required when the research involves greater than 
minimal risk with no prospect of direct benefit to the child.  The requirements for signature of both parents may be 
waived if one parent is deceased, unknown, incompetent, or not reasonably available, or when one parent has sole 
legal responsibility for the care and custody of the child.  If the participant is a child who is capable of giving assent, 
the child should also sign the attached Assent Form. 

Prot_SAP_002.pdf: 
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Date: Friday, August 18, 2017 12:27:29 PM
Print
Close
ID: 2017-1304
 Help
VIEW000072 
Study Identification Information
This is the first step in your Human Research Application.  You will automatically be guided
to the appropriate forms needed to complete your submission.
 
1.0
Title: (please do not use initials)
The effect of dexmedetomidine dose on motor evoked potentials during spine
surgery: A randomized, single-blind trial
 
* Short Title for EPIC:
Dexmedetomidine and MEPs during spine surgery (If Not Applicable, please enter
N/A)
 
2.0
Description:
This parallel group, two-arm, randomized superiority trial will compare the effect of
two different doses of dexmedetomidine on motor evoked potentials during spine
surgery.
 
3.0
* Principal Investigator:
Ronald Emerson, MD
 
4.0
Study Contact:
 
 
5.0
Co-Investigators:
First Name
Last Name
Organization
Matthew
Cunningham, MD, PhD
Spine
Kara
Fields
Research
Han Jo
Kim, M.D.
Spine
Frank
Schwab, M.D.
Spine
Michael
Urban, MD PhD
Anesthesiology
 If a name does
not appear in
Co-Investigators
directory, please
contact
zhouy@hss.edu
to have an eCAP
account created.
6.0
Other Study Staff/Collaborators:
FirstName
LastName
Organization
Email
Role
There are no items to display
 


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7.0
* Type of Application:
Clinical Research Proposal
Expedited Retrospective Chart Review
Request for Exemption
New Registry
Existing Approved Registry
Please click here
to preview
Exempt
Categories.
Click here to
preview Study
Designs.
8.0
Select appropriate funding sources for this study: 
Name
Internally Funded Support
 
Other Funding Sources: 
Note: If the funding source of the study is 'Industry Funded
Support', Clinical Research Administration (CRA) will be
notified.
If your study requires CRA review, please upload applicable documents,
including sponsor protocol, drug brochure, etc :
Name
Version
There are no items to display
Help 
ID: 2017-1304
Help 
CRP Information
 
 
1.0
The proposal should be submitted to the appropriate Clinical
Review Panel (CRP) for scientific review. If you are unsure of
which Clinical Review Panel to select, please contact
Barbara Bosco at 212.606.1914 
* 
Name
Neurology
 
 
 
 
 
Help 


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ID: 2017-1304
Help 
Regulatory Status of Drugs and Devices
 
1.0
The regulatory status of the drugs or devices in this research
proposal is:
Name
Approved for use by the FDA and being used according to “label” (for approved
indication)
 
Help 
ID: 2017-1304
Help 
FDA Approved Drugs/Devices
 
1.0
Add all FDA Approved Drugs administered in this study:
Drug Name
Manufacturer
Drug Name (if other)
Manufacturer (if other)
Other
 
Dexmedetomidine
Pfizer
 
 
Propofol
Pfizer
 
 
2.0
Add all FDA Approved Devices administered in this study:
 
Device Name Manufacturer Device Name (if other)
Manufacturer (if other)
View  
 
Cadwell Cascade
Cadwell, Inc.
View  
 
NICOM
Cheetah Medical
 
ID: 2017-1304
Help 
Pharmacy Involvement / Impact to EPIC
1.0
Is this an inpatient study?
  
Yes 
No
 
2.0
* Will this study have Investigational Drug Service involvement?
(Pharmacy will be purchasing/dispensing any medications being
used and/or study requires placebo and patient randomization) 
  
Yes 
No
 
3.0
If the answer to either question is yes, please explain briefly below
AND contact Mylinh Duong at 646.797.8410 (duongm@hss.edu) or
Nicole Oliva at 646.797.8324 (OlivaN@hss.edu).
This is an inpatient study to be performed during surgery.  Anesthetic drugs to be
 


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used are routinely used during surgery and will not require pharmacy involvement.
 
 
Help 
 
 
ID: 2017-1304
Help 
Study Locations
 
1.0
Select the Research Facilities where this study will be
conducted:
Facility
HSS
 
1.1 If Other, please specify:
 
2.0
* Is this a multi-Center study?
No
 
 
 
ID: 2017-1304
This section will be reviewed by the appropriate Clinical Review Panel. Each
of the headings in this section must be addressed.
Help 
Specific Aims or Research Questions
 
1.0
What is the condition or intervention to be studied?
We will study motor evoked potentials under two anesthetic conditions, one using
propofol and lower dose of dexmedetomidine, another using a lower dose of
propofol with a higher dose of dexmedetomine during multilevel posterior spinal
fusions.
Please click
Here for
example.
2.0
What is/are the research question(s)/specific aim(s)? Pose
very specific questions that can be addressed within the
proposed design of the study. Prioritize them in order of
 


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importance.
 
Aim 1 (definitive): To compare the percentage of spine cases with monitorable
motor evoked potentials (MEPs) for the purpose of monitoring spinal cord integrity
under two anesthetic conditions, one using a higher dose of propofol and a lower
dose of dexmedetomidine, and the other using a lower dose of propofol and a
higher dose of dexmedetomidine.
Aim 2 (exploratory): To estimate the difference in percentage of spine cases with
monitorable MEPs for the purpose of monitoring nerve root integrity between two
anesthetic conditions.
Aim 3 (exploratory): To estimate the association between MEP metrics (peak to
peak amplitude, waveform integral, waveform line-length, trial variability of peak to
peak amplitude, trial variability of waveform integral, and trial variability of
waveform line-length) and cardiac output. 
3.0
What is/are the hypothesis(es)?
There will be a difference in the percentage of spine cases with monitorable MEPs
for the purpose of monitoring spinal cord integrity under two anesthetic conditions.
 
 
4.0
Identify and define the primary outcome and when the
outcome will be measured. If measuring change in post-
operative function is the most important, that will be your
primary outcome.
Monitorable MEPs for the purpose of monitoring spinal cord integrity (yes vs. no).
 This outcome measure will be assessed during the initial two hours of surgery
following induction of anesthesia and establishment of stable anesthesia.  MEP
recordings will be obtained in sets of 3-4 trials, approximately every 15-20 minutes,
as permitted by the surgeon.
Monitorable will be defined as having MEPs present in 3 muscles in each lower
extremity, with mean peak-to-peak amplitude of at least 50 uV, with mean-
normalized interquartile variability of 0.9 or less. 
 
5.0
Identify and define the secondary outcome(s) and when they
will be measured (list additional goals one at a time with their
corresponding outcomes).
1) Monitorable MEPs for the purpose of monitoring nerve root integrity present at
all assessments (yes vs. no). For this purpose, MEPs will be separately assessed
in quadriceps, tibialis anterior, extensor hallucis longus, medial gastrocnemius and
abductor hallucis in each lower extremity. Monitorable will be defined as having
MEPs with mean peak-to-peak amplitude of at least 50 uV, with mean-normalized
interquartile variability of 0.9, separately for each muscle. This outcome measure
will be made during the first two hours of surgery following induction of anesthesia
 


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and establishment of stable anesthesia.
2) MEPs (peak to peak amplitude, waveform integral, waveform line-length, trial
variability of peak to peak amplitude, trial variability of waveform integral, and trial
variability of waveform line-length) measured in quadriceps, tibialis anterior,
extensor hallucis longus, gastrocnemius, and abductor hallucis. These measures
will be calculated from data recorded throughout the case, following establishment
of stable anesthesia through the conclusion of surgery.
3) Cardiac output, measured continually during surgery.
 
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ID: 2017-1304
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BACKGROUND - Be sure to answer each question individually
 
1.0
Explain why these research questions are being asked:
Many general anesthetic agents can affect MEPs in ways that can make
them difficult to monitor and can confound their interpretation.
 Dexmedetomidine in increasingly being used as a component of total
intravenous anesthesia during surgery requiring MEP monitoring. It is
therefore important to determine the effect of dexmedetomidine of MEPs. 
Optimal fluid management is challenging during complex spine surgery
accompanied by large amounts of blood loss, for reasons detailed in 2.0.  This
study aims to determine if there a correlation between MEP waveform measures
and cardiac output, that could potentially could be useful as a guide to fluid
management. 
Peak-to-peak amplitude is the most commonly clinically employed measure of
MEPs.  For reasons discussed in 2.0, the integral of the rectified waveform or
waveform line-length may be superior measures.  
 
 
 
 
2.0
What is the background of the topic that you believe is
important for the reviewer to know in considering this
protocol, including prior studies by this research team. 
Describe strengths and deficiencies of prior studies; explain
how this study fits in.  Include references.
Motor evoked potentials (MEP), monitored during spine surgery as measures
of spinal cord integrity, are known to be attenuated in a dose related fashion
by nitrous oxide and volatile anesthetic agents.   Propofol has been shown to
better preserve MEPs. For this reason, propofol is commonly used, along
 


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with an opioid and often ketamine, for cases requiring MEP monitoring.  The
addition of dexmedetomidine to total intravenous anesthesia  during spine
surgery has recently been shown to reduce the required propofol dose as
well as improve the quality of recovery, possibly related to decrease the
release of cytokines.  Reduction of propofol dose is desirable, both because
of rare metabolic risks as well as the known effect of delayed emergence [1-
8].  
A challenge for the anesthesiologists during complex spine surgery is to
maintain end organ perfusion despite large blood losses in an attempt to
prevent devastating complications such as spinal cord ischemia, ischemic
optic neuropathy (ION), renal failure, myocardial ischemia and stroke. The
best approach to achieve euvolemia and prevent end-organ ischemia and
metabolic acidosis is still a dilemma. Despite the ubiquitous use of central
venous pressure (CVP) monitoring during large blood loss procedures, there
is a poor direct correlation between CVP and blood volume, as well as the
ability of changes in CVP to predict the hemodynamic response to a fluid
challenge. Volume resuscitation with a pulmonary artery catheter (PAC) has
been shown to be beneficial during adult reconstructive spinal surgery.
However, multiple published reports have questioned the value of PAC
monitoring. Arterial and central venous blood gas analysis may provide
information regarding tissue oxygenation requirements and perfusion. Urine
output alone correlates poorly with adequate tissue perfusion, since oliguria
may be a consequence of excess antidiuretic hormone release rather than
hypovolemia and therefore, attempts to increase urine output intraoperatively
may result in excessive fluid administration. Devices which measure arterial
pulse pressure variation and provide non-invasive cardiac output
measurements have been shown to be efficacious in providing goal directed
fluid therapy during complex spine procedures. The Cheetah NICOM uses
thoracic bioreactance, a measure based on phase modulation of an
oscillating current traversing the thoracic cavity, to noninvasively measure
cardiac output and fluid responsiveness. Cardiac output measured by the
NICOM device has been shown to correlate with measurements made by
thermodilution and pulse contour analysis, and has been found to be
efficacious in fluid management during large blood loss procedures [9-12]. 
Motor evoked potentials are dependent on adequate perfusion in watershed
regions along anterior spinal artery, as well as within the gray matter of the
lumbar enlargement. As such, they are highly sensitive to hemodynamic
effects [13].  Anecdotal observations suggest that MEP changes, particularly
changes observed in MEPs from higher stimulation threshold muscles, may
be early indictors of inadequate perfusion. This study aims to better
characterize this relationship, and determine whether MEP changes precede
changes in measured cardiac output, potentially serving as guides to
fluid management. 
The motor evoked potential signal is a complex polyphasic waveform
comprising the sum of signals generated by individual motor units within the
listening spheres of the recording electrodes; approximately 5% of motor
units in a large muscle are sampled in the typical clinical recording.   Ideally,
a MEP metric would be linearly proportional to the number of motor units
activated.  Although most commonly employed clinically, it is unlikely that
peak-to-peak amplitude is ideal, because the signals from individual motor
units are asynchronous with varying phase relationships, and are influenced


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unevenly by proximity the recording electrodes.  The extreme case,
occasionally encountered, is a large, brief, biphasic signal, with large peak-
to-peak amplitude, probably generated by a single motor unit very close a
recording electrode [13].  Although also imperfect, it is likely that the integral
of the rectified waveform, or line-length of the waveform, may well be better
measures. The strength of correlation of each of these measures to
cardiac output may inform selection of the most robust measure.   
MEP signals commonly exhibit considerably trial-to-trial variability.  This
variability does not reflect “measurement error”, but rather reflects
spontaneous fluctuation of motor-pool excitability resulting in changing motor
unit contributions to the MEP signal.  Trial-to-trial variability is influence by
numerous factors, including anesthesia and hemodynamics.   If shown to
correlate with cardia output, MEP  (peak-to-peak amplitude, integral, line-
length) variability, may also provide additional, useful, metrics. 
 
1.    Gertler R, Brown HC, Mitchell DH, Silvius EN. Dexmedetomidine: A novel
sedative-analgesic agent. Proc (Bayl Univ Med Cent) 2001;14:13–21.
2.    Liolios A, Guerit JM, Scholtes JL et al. Propofol infusion syndrome associated
with short-terms large dose infusions during surgical anesthesia in an adult. Anesth
Analg 2005;100:1804-6.
3.    Grottke O, Dietrich PJ, Wiegles S et al. Intraoperative wake-up test and
postoperative emergence in patients undergoing spinal surgery: A comparison of
intravenous and inhaled anesthetic technique using short acting anesthetics. 
Anesth Analg 2004;99:1521-1527.
4.    Dutta S, Karol MD, Cohen T, et al. Effect of dexmedetomidine on propofol
requirements in healthy subjects. J Pharm Sci. 2001; 90:172-81.
5.    Mahmoud M, Sadhasivam S, Sestokas AK,et al. Loss of transcranial electric 
motor  evoked  potentials  during  pediatric  spine  surgery  with  dexmedetomidine.
Anesthesiology. 2007;106:393-6
6.    Bala E, Sessler DI, Nair DR et al.   Motor and somatosensory evoked
potentially are well maintained in patients given dexmedetomidine during spine
surgery.  Anesthsiology 2008; 109:417-425.
7.    Tobias JD, Gobel TJ, Bates G, et al. Effects of dexmedetomidine on
intraoperative motor and somatosensory evoked potential monitoring during spinal
surgery in adolescents.  Ped Athesth 2008; 18: 1082-1088.
8.    Li Y, Meng L, Peng Y, et al. Effects of dexmedetomidine on motor- and
somatosensory-evoked potentials is patients with thoracic spinal cord tumor: a
randomized controlled trial. BMC Anesthesiol 2016:16;51.
9.    Kossari N, Hufnagel G, Squara.  Bioreactance: A new tool for cardiac output
and thoracic fluid content monitoring during hemodialysis.  Hemodialysis
International. 2009;13:512-517.
10.  Marik P et al. The use of bioreactance and carotid Doppler to determine
volume responsiveness and blood flow redistribution following passive leg raising in
hemodynamically unstable patients. Chest 2013; 143:364-370.


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11.  Waldron N et al. A prospective comparison of a noninvasive cardiac output
monitor versus esophageal Doppler monitor for goal directed fluid therapy in
colorectal surgery patients. Anesth Analg 2014; 118:966-75.
12.  Dunham, CM et al. Emergency department noninvasive (NICOM) cardiac
outputs are associated with trauma activation, patient injury severity and host
conditions and mortality. J Trauma Acute Care Surg. 2012; 73:479-85.
13.  MacDonald DB, Skinner S, Shills J and Yingling C. Motor evoked potential
monitoring - a position statement of the American Society for Neurophysiological
Monitoring. Clinical Neurophsiology 2013;124:2291-2316.
3.0
Identify specific gaps in current knowledge that this study is
intended to fill.
Both propofol and dexmeditomidine produce dose-related attenuation of MEPs. 
There is limited data concerning the combined effect of the two agents.  Taken
together, the limited available literature suggests that combined with propofol at 70
ug/kg/min, dexmeditomidine 0.5 ug/ml/hr does not produce significant attenuation
of MEPs, although attenuation of MEPs may occur when it is combined with higher
propofol doses.  Significant attenuation of MEPs is more frequent at higher doses
of dexmedtomidine in combination with propofol, although previous studies have
been conducted using propofol doses higher than are proposed in this study.
It is not known whether MEP changes may be useful as guides for fluid
management during complex spine procedures.
The optimal metric for quantitative characterization of MEPs in not known.  
 
 
 
4.0
How will answering these questions change clinical practice,
change concepts about the topic or confirm the work of other
investigators?
This study will inform the best practice of intraoperative monitoring by establishing
acceptable doses of dexmeditomidine, in combination with propofol, for use in
conjunction with MEP monitoring.   This study will also provide insight into the
relationship between MEPs and cardiac output, and provide insight into whether
MEP changes may potentially be useful into the management of fluid status during
spine surgery.   This study will also provide insight into improved MEP metrics, that,
perhaps in the future, could be incorporated into clinical recording systems. 
 
5.0
Is this a pilot study that could lead to a more definitive
protocol or different study?   
Yes 
No
 
5.1 If you answered No, please explain below: 
 


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6.0
Please upload reference or additional document here (if
needed).
Name
Description
There are no items to display
 
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ID: 2017-1304
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Study Design
 
1.0
Observational:
Name
Description
There are no items to display
 
2.0
Experimental:
Name
Description
Randomized
Controlled
Clinical Trial
This is the “gold standard” for clinical research. These prospective
studies have at least two groups. Patients meeting strict
inclusion/exclusion criteria are enrolled and randomly assigned to
receive either an experimental intervention or to receive what is
considered to be an acceptable alternative – usually the current
standard of care or a placebo (e.g., study of hylauronic acid injection
versus cortisone for arthritis).
 
2.1 If Other, please specify: 
 
2.2 If Randomized Controlled Clinical Trial is selected, please
choose one of the following:
Name
Other
 
If other, please list name or indicate N/A below:
Randomized trial of different doses of standard FDA approved anesthetics.
 
ID: 2017-1304
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Recruitment
 
1.0
Check all that apply to describe your study population:
 


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Population
Patients
Vulnerable Populations
There are no items to display
1.1 If Other, please specify: 
 
2.0
Inclusion Criteria: list characteristics that potential subjects and
controls need to have. Use a bullet format, if applicable.
Subjects will be within the age range of 18 – 70 years.
Subjects will be patients undergoing multi-level posterior spine fusions
requiring MEP monitoring
 
 
 
3.0
Exclusion Criteria: list characteristics that would cause you to
exclude potential subjects and controls.
Justify any age, ethnicity, language, or gender-based
exclusion criteria. Use a bullet format, if applicable.
Allergy to any of the anesthetic medications included in the protocol
Non-English speaking
Younger than 18 and older than 70 years of age
Any other surgery other than multi-level posterior spine fusions
 
 
 
4.0
Age Range:
18-70 years
 
5.0
Describe how you will identify and recruit potential subjects
for participation in the study.
 
Potential patients will be recruited as a consecutive series of patients
undergoing multi-level posterior spine fusions requiring MEP monitoring. 
Recruitment will begin following approval of the study, and will be conducted
by the principal investigator or an IRB approved co-investigator.
 
 


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6.0
* Please select enrollment type from following drop down list: 
Over Course of Study
 
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ID: 2017-1304
 
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Target Enrollment
 
1.0
* What is the maximum number of subject you plan to enroll in
this study at HSS?(Please enter a number)
68
 
2.0
If this is a multi-center study, indicate the projected total
subject accrual across all sites.
 
 
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ID: 2017-1304
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Patients  
 
1.0
Please check the box(es) below that best reflect how patients
will be identifed and recruited for participation. 
 
How subjects will be identified
Potential subjects will be identified after a review of medical records of
patients under the care of one or more of the study investigators
Medical records and/or other Institution sources (databases,registries,billing
records,pathology reports,admission logs) will be reviewed to identify potential
participants. May involve access of records by individuals not involved in the
patient's care.
Potential subjects will be identified by their treating physicians and referred to
the researchers. Patients' private and identifiable information will not be shared
prior to receiving permission from the patient to do so.
Potential subjects will be identified from a registry of individuals interested in
research opportunities.
Subjects will roll-over from another research study.
Potential subjects will self-refer in response to advertisements.
 
 
 
ID: 2017-1304
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Interventions and Observations
 
1.0
 


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Be specific and describe the Interventions or
Observations that will be part of this research project. Include
a detailed description of the treatment arms, if applicable.
Patient will undergo endotracheal intubation and general anesthesia will be
induced using propofol, fentanyl, midazolam, and vecuronium.
All patients will be monitored with standard ASA monitors.  An indwelling
arterial catheter will be placed, and electrode for the NICOM monitor will be
applied. During the procedure, an arterial blood sample will be assessed for
blood gas analysis, pH, blood glucose, Hb and lactate.
Once positioned prone, maintenance anesthetic will include 02/Air, diazepam
2 mg/hour up to a maximum total of 10 mg, and an infusion of fentanyl 1
mcg/ kg/hr and ketamine 2 mcg/kg/hr, a loading dose of 1 mcg/kg of
dexmedetomidine administered over, plus one of two anesthetic Treatments.
Treatment 1: Propofol 50 mcg/kg/min + dexmedetomidine 0.5 mcg/kg/hr
Treatment 2: Propofol 25 mcg/kg/min + dexmedetomidine 1.0 mcg/kg/hr.
If MEPs are clinically determined to be unmonitorable for patients receiving
treatment 2, they will be converted to treatment 1.  If MEPs continue to be
unmonitorable, anesthetic management will be at the discretion of the
attending anesthesiologist.   If MEPs are unmonitorable for patient receiving
treatment 1, anesthetic management will be at the discretion of the attending
anesthesiologist.
Cardiac output will be measured continuously during the procedure. A
decrease in cardiac output by 20% or an increase in lactate >2mEq/l will
prompt the administration of fluid and/or blood is the Hb is less than 8mg/dl.;
to restore the values to baseline. Any deterioration of MEPs will prompt the
assessment of metabolic acidosis, cardiac output and Hb level.
Patients may also receive boluses vaso-active medications to control HR and
BP.
Motor evoked potentials will be performed in the standard manner. Simulating
electrodes will be placed 2 cm anterior to C1 and C3, and C2 and C4
locations of the International 10-20 system.  C1 and C3, and C2 and C4
electrodes will be joined using a Y connector, to produce one right and one
left cranial electrode.  Recording electrodes will be placed in right and left
tibialis anterior, abductor hallucis, extensor hallucis longus, medial
gastrocnemius, vastus lateralis and rectus femoris muscles. Stimuli will be
two sequential trains of 2 then 5 pulses, each pulse 50 microsecond
durations, with an inter-pulse intervals of 2 milliseconds and an inter-train
interval of 10 and 20 milliseconds.  Stimulation voltage will be adjusted to
obtain responses in all muscles if possible.  MEPs will be performed at
standard intervals, typically once every 20 minutes, as permitted by the
surgeon.
Additionally, following establishment of stable anesthesia, the stimulation
voltage threshold for each muscle will be determined by beginning at 125
volts and increasing at 25 volt increments until a response is obtained in
each muscle, and recording the voltage at which the MEP was first recorded


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in each muscle.
 
2.0
Will you be collecting human fluid or tissue?   
Yes 
No
 
If yes, what will you be collecting?   
  Fluid      
  Tissue
(Intraoperative and/or outpatient collection)
 
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ID: 2017-1304
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Data Collection
 
1.0
Indicate what data will be collected.
MEP voltage threshold values for each muscle will be recorded manually.
Timestamped MEP waveform data are recorded and stored automatically by
the Cadwell clinical intraoperative monitoring machine.
Timestamped cardiac output data are stored automatically by  the NICOM
device.
Anesthesia data and blood pressure are stored automatically in EPIC.
Arterial PO2, PCO2, pH, lactate, glucose, and hemoglobin will be sampled
and recorded at clinically determined intervals.
 
 
 
2.0
Who will collect the data:
Ronald
 
Emerson, MD
 
Michael
 
Urban, MD PhD
 
 
3.0
When the data will be collected? Include timing of visits(either
SOC or specifically for the study). 
During each surgery
 
4.0
From what source:
Medical Records
No Private Office Charts     Please specify which private office:
No Registries     Please specify which registry: 
 


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 Other   Please specify:  NICOM and Cadwell Cascade machines
 
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ID: 2017-1304
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General Methods and Procedures
 
1.0
* Are controls included in the study? No
 
1.1 If yes, describe how they will be matched with the study subjects; state
whether the controls will have identical data recorded, or describe any
differences compared to the intervention subjects. 
 
2.0
* Are all tests Standard of care? No
If not, identify which tests are not standard of care. What source of funds
will be used to pay for them (text box below):
Use of the NICOM monitor is not standard of care at HSS, but HSS does own a
NICOM monitor.  There will be charge to the patient for its use.
 
3.0
* Will surveys/questionnaires be used?  No
 
4.0
* Does the study involve randomization?  Yes
 
5.0
* Does your study included Placebo or No-Treatment Arm? No
 
6.0
* Does your study included Washout of Previous Medication?
No
 
7.0
Data collection sheet should be created for the study and
uploaded: 
Name
Version
There are no items to display
 
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ID: 2017-1304
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Randomization
1.0
Please state who will do the Randomization:
The randomization schedule will be generated by a member of the Healthcare
Research Institute not otherwise involved in the trial.
 
2.0
Please state when the Randomization will be done:
 


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The randomization schedule will be generated prior to the start of study enrollment.
After consent is obtained, the anesthesiologist will be given a sealed opaque
envelope corresponding to the patients study ID number and randomized to one of
the two treatment groups. The envelope will be opened in the operating room, not
in the presence of other investigators.
3.0
Please state how the Randomization will be performed:
A Healthcare Research Institute member not otherwise involved in the trial will
prepare the randomization schedule using SAS software.  Group assignment will
be indicated on cards within numbered sealed opaque envelopes.  The envelopes
will be prepared by a staff member not otherwise involved in the trial. 
 
4.0
Please state who will insure that the Randomization is carried
out and if anyone will be blinded to the Randomization group:
All investigators except for the anesthesiologist will be blind to the randomization
group.
 
 
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ID: 2017-1304
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Sample Size and Data Analysis
If you are uncertain about how to calculate your sample size and determine appropriate
data analysis, please contact the Epidemiology and Biostatistics Core at biostats@hss.edu
for assistance in completing this section.
 
1.0
Is this is a case series based only on the patients available
using descriptive statistics in lieu of a sample size
calculation?
* No
 
 
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ID: 2017-1304
Help 
Sample Size and Data Analysis 
Support estimates with evidence from the literature of prior studies and perform an
appropriate sample size calculation.
 


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For hypothesis testing (e.g., the calculation of p-values using statistical tests), you need to
estimate your available sample size and calculate the effect size that will be detectable
using your proposed statistical analysis plan. This also applies to a case series where you
plan hypothesis testing.
 
1.0
If you have consulted with a statistician, please indicate their
name:
Kara Fields
 
2.0
Proposed sample size analysis, include the following:
Student's t-test, ANOVA, chi-square, regression, etc;
Alpha level;
Beta or power level;
Primary outcome variable estimate (mean +/-s.d. for
continuous outcome, frequency/percentage for
categorical variable);
Number of groups being compared (use 1 for paired
analysis within the same subjects);
Effect size or change expected between groups;
Resulting number per group
1. Proposed analysis (e.g., student’s t-test, ANOVA, chi-square,
regression, etc.):  Fisher’s exact test
2. Alpha level:   0.05 (two-sided)
3. Beta or power level:  80% power
4. Primary outcome variable estimate (mean +/- s.d. for continuous
outcome, frequency/percentage for categorical variable): 
Percentage of patients with monitorable MEPs for the purpose of monitoring
spinal cord integrity in 0.5 ug/kg/hr dexmedetomidine group = 100% *.
 Percentage of patients with monitorable MEPs for the purpose of
monitoring spinal cord integrity in 1.0 ug/kg/hr dexmedetomidine group =
75%.
5. Number of groups being compared (use 1 for paired analysis within
the same subjects):  2
6. Effect size or change expected between groups:  25 percentage point
difference
7. Resulting number per group: 31
Total sample size required:  62 + 10% to account for missing/unusable data = 68
* Li Y, Meng L, Peng Y.  Effects of Dexmedetomidine on motor-
and somatosensory-evoked potentials in patients with thoracic spinal cord
tumor: a randomized controlled trial.  BMC Anesthesia. 2016;16:51. DOI
10.1186/s12871-016-0217-y
 
3.0
Data Analysis: describe how the primary outcome will be
 


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analyzed and what types of statistical calculations will be
used. Do the same for each secondary outcome. Reiterate
briefly the main analysis to be done, which groups, which
variables, possible confounders. Address how possible
confounders will be identified and handled in analysis: 
The percentage of patients with monitorable MEPs for the purpose of monitoring
spinal cord integrity present at all assessments (yes vs. no), the primary outcome,
will be compared between groups using Fisher’s exact test.
The percentage of patients in each group with monitorable MEPs for the purpose of
monitoring nerve root integrity present at all assessments (yes vs. no) will be
presented as risk difference and relative risk with 95% confidence intervals.
The correlation between MEP metrics (peak to peak amplitude, waveform integral,
waveform line-length, trial variability of peak to peak amplitude, trial variability of
waveform integral, and trial variability of waveform line-length) and CO over time
will be assessed via mixed modeling. Correlation coefficients will be presented as
point estimates along with 95% bootstrap confidence intervals.
Balance on demographics and baseline characteristics will be assessed by
calculating standardized differences (difference in means or proportions divided by
the pooled standard deviation) between groups. Balance will be assessed using
two thresholds: (1) 1.96 x (2/34)1/2 = 0.475 and (2) 0.2 (Austin 2009).
 
References
1. Austin PC. Balance diagnostics for comparing the distribution of baseline
covariates between treatment groups in propensity-score matched samples.
Stat Med 2009; 28: 3083-107.
 
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ID: 2017-1304
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Consent Information
 
1.0
Describe how, when, and where the consent process will be
initiated:
Informed consent will be obtained in the holding area, prior to surgery, by the
principal investigator or an IRB approved co-investigator 
 
2.0
Who will obtain informed consent from subjects for this
research?
First Name
Middle Name
Last Name
Title
Ronald
 
Emerson, MD
 
 


8/18/17, 12(27 PM
Print: 2017-1304 - The effect of dexmedetomidine dose on motor evoked potentials during spine surgery: A randomized, single-blind trial
Page 19 of 19
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSm…alse&PrintLogo=True&showHiddenData=False&showCDTFormsAtEnd=True
Michael
 
Urban, MD PhD
 
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ID: 2017-1304
 
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