Clinical trial NCT04356352
Conditions: Injection Site Irritation Pain
Sponsor: Wake Forest University Health Sciences
Start date: 2020-09-09; Completion date: 2023-08-25
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary hypothesis is that esmolol and lidocaine, when given without the use of a tourniquet, provide relief of propofol injection pain that is superior to placebo when assessed using the propofol pain scoring tool

Detailed description:
The study will include three arms: lidocaine, esmolol, and placebo. Eligible patients will be 18-60 years old, ASA physical status 1-3, and scheduled for an elective surgical procedure. Patients will be randomized to receive lidocaine, esmolol, or placebo. Both the patients and the administering/observing providers will be blinded to the study drug or placebo being administered

Arms: arm 1: 1 mg/kg lidocaine to a max of 100 mg arm 2: 0.5 mg/kg esmolol to a max of 50 mg arm 3: Saline water
Interventions: intervention 1: Lidocaine intervention 2: Esmolol intervention 3: Placebo
Intervention descriptions: intervention 1: 1 mg/kg lidocaine to a max of 100 mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. intervention 2: 0.5 mg/kg esmolol to a max of 50mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. intervention 3: saline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.

Protocol documents:
Prot_SAP_001.pdf: 
 
 
LEP protocol ver 06272022 
 
 
1 
 
A Comparison of Lidocaine, Esmolol, and Placebo Without Use of a 
Tourniquet for Relieving Pain from Intravenous Administration of Propofol 
 
 
IRB00063576NCT 
 
 
NCT 04356352 
 
 
IRB Approval Date:  08JUN2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
LEP protocol ver 06272022 
 
 
2 
Study Title: A Comparison of Lidocaine, Esmolol, and Placebo Without Use 
of a Tourniquet for Relieving Pain from Intravenous Administration of 
Propofol 
 
Principal Investigator, Co-investigator(s):  Michael Norton, MD; Wesley Templeton, MD; 
Leah Templeton, MD; Deborah Whelan, MD; Justin Traunero, MD; Sarah Kittner, MD; Jordan 
Rejeski, MD; Richard Flowers, DNP, CRNA; Grace Simpson, CRNA; John Korona, MD;  Susan 
Vishneski, MD; Scott Miller, MD; Randy Calicott, MD; John Bradshaw, MD; Rohesh Fernando, 
MD 
 
Sponsor or funding source: Department of Anesthesiology 
 
Background 
 
It has long been known that propofol causes pain on intravenous injection (1).  This pain is 
multifactorial in origin, stemming from direct mucosal irritation as well as stimulation of 
nociceptive sensory nerve fibers in the venous adventitia (2).  Lidocaine has frequently been 
administered either in advance or concomitantly with propofol to attenuate this response.  
Studies have noted varying degrees of success with this technique but have clearly demonstrated 
an improvement in propofol injection pain when lidocaine is administered in combination with 
venous occlusion by a tourniquet (3, 4, 5, 6, 7). 
 
Adrenergic signaling pathways participate in the neurotransmission and modulation of pain.  
2 
agonists have been shown to work synergistically with opioids to exert anti-nociceptive effects 
(8), and 
1 antagonists possess similar properties (9).  Esmolol has been shown to decrease 
perioperative anesthetic and narcotic requirements (10, 11), and one study showed that 
perioperative esmolol administration decreased postoperative opioid requirements for up to three 
days after surgery (12).  Another study demonstrated that an intraoperative esmolol infusion 
decreased emergence times, postoperative narcotic requirements, and the time to discharge after 
ambulatory surgery (13).  Esmolol has also been found useful for decreasing pain upon injection 
of a venous irritant: it decreases the pain associated with rocuronium injection (14) and may be 
even more effective than lidocaine at attenuating propofol injection pain when used in 
combination with a tourniquet (15).  Importantly, it has proven to be effective at blunting the 
cardiovascular response to a noxious stimulus without causing clinically significant bradycardia 
and hypotension (16). 
 
Despite the results of the above cited studies, most clinicians seldom use a tourniquet when 
giving lidocaine to attenuate propofol injection pain.  In addition, esmolol’s utility in preventing 
this pain has not been studied in the absence of a tourniquet.  The goal of the present study is to 
determine whether lidocaine or esmolol is effective at preventing propofol injection pain when a 
tourniquet is not used. 
 
In clinical practice, we commonly administer IV lidocaine from premixed syringes containing 
100 mg of the drug dissolved in 5 ml. Most providers administer 1 mg/kg body weight, and few 
if any will open a second syringe when patients weigh more than 100 kg. Since the goal of this 
trial is to observe the clinical efficacy of this drug when administered the way it is usually done 


 
 
LEP protocol ver 06272022 
 
 
3 
by practicing clinicians, we decided to administer 1 mg/kg lidocaine to a maximum of 100 mg. 
In order to maintain blinding and consistency in this trial, we decided esmolol should be 
administered to a maximum of 50 mg since it will be mixed to half the concentration of the 
lidocaine -- this ensures that an equal volume of study drug will be administered, thus helping us 
maintain double blinding. 
 
The study will include three arms: lidocaine, esmolol, and placebo.  Eligible patients will be 18-
60 years old, ASA physical status 1-3, and scheduled for an elective surgical procedure.  Patients 
will be randomized to receive lidocaine, esmolol, or placebo.  Both the patients and the 
administering/observing providers will be blinded to the study drug or placebo being 
administered. 
 
Objectives 
 
Our primary hypothesis is that esmolol and lidocaine, when given without the use of a 
tourniquet, provide relief of propofol injection pain that is superior to placebo when assessed 
using our propofol pain scoring tool. 
 
Setting 
This study is taking place at Wake Forest Baptist Medical Center in the perioperative setting.  
Subjects will already be planning on having an elective surgical procedure and be anticipating 
having a general anesthetic receiving propofol as part of that procedure.   
 
Subjects selection criteria 
 
Inclusion criteria 
● 18-60 years of age 
● ASA 1-3 
● Elective surgical procedure 
 
Exclusion criteria 
● BMI ≥ 45 
● Pregnancy 
● Requirement for RSI or awake intubation 
● Suspected or known difficult airway 
● Any use of opioids in the last week 
● Significant cardiopulmonary or hepatic dysfunction 
● Hypersensitivity to study medications 
 
Study Procedures, Interactions and Interventions 
● Obtain informed consent and randomize patient into one of three groups (lidocaine, 
esmolol, placebo) 
● Dose medications based on actual body weight 
● Start 20 gauge IV in either extremity and hang lactated ringers (LR) 
● Administer no sedative or analgesic (i.e., no Versed or fentanyl) prior to induction 
● Place standard monitors and preoxygenate patient 


 
 
LEP protocol ver 06272022 
 
 
4 
● Administer study medication as a bolus 
o 1 mg/kg lidocaine to a max of 100 mg, 0.5 mg/kg esmolol to a max of 50 mg, or 
placebo 
o Lidocaine will be 20 mg/ml and esmolol will be 10 mg/ml 
▪ 
These concentrations allow us to simply administer 0.05 ml solution per 
kg regardless of which group the patient has been randomized into – 100 
kg patient would receive 5 ml solution that would contain 100 mg 
lidocaine (= 1 mg/kg), 50 mg esmolol (= 0.5 mg/kg), or saline 
o Allow patient’s IV to run freely 
● 20-30 seconds after administration of study medication, bolus 0.5 mg/kg propofol to a 
max of 50 mg 
● Record patient’s pain over the next thirty seconds 
o Use the pain scale previously published by McCrirrick and Hunter (Anaesthesia 
1990;45(6):443-4). 
▪ 
0 = no pain 
▪ 
1 = mild pain 
● Pain reported in response to questioning AND NOT accompanied 
by a physical sign (grimacing, withdrawal, tears, etc.) 
▪ 
2 = moderate pain 
● Pain reported in response to questioning AND accompanied by a 
physical sign 
● Pain reported spontaneously AND NOT accompanied by a 
physical sign 
▪ 
3 = severe pain 
● Pain eliciting a strong vocal response 
● Pain reported spontaneously AND accompanied by a physical sign 
● Proceed with induction at the discretion of the attending anesthesiologist 
o If patient requires a NDMB, use vecuronium instead of rocuronium (due to 
venous irritation caused by rocuronium) 
● Record vital signs every minute after induction for ten minutes 
o Also record administration of any medications given to treat hemodynamic 
derangements during this time frame (phenylephrine, ephedrine, propofol, etc.) 
o Do not administer esmolol for tachycardia during this time frame unless the 
patient shows evidence of myocardial ischemia or other significant derangements 
 
Sample Size 
 
150 patients (50 in each arm) is anticipated to be needed in this study.  
 
Outcome Measure 
 
Our primary outcome measure will be the proportion of patients with pain using a pain scoring 
system previously used by studies looking at various remedies to decrease propofol injection 
pain (15, 17).  In this scoring system, patients are observed and their responses and behaviors are 
rated according a specific rubric (Table 1) (17).  This assessment will be performed by a blinded 


 
 
LEP protocol ver 06272022 
 
 
5 
member of the study team following administration of a sub-induction dose of propofol, 0.5 
mg/kg up to 50 mg, just prior to full induction. 
 
Our secondary outcome measure will be heart rate, blood pressure, and SpO2 every minute 
following induction.  We will record vital signs each minute for the first 10 minutes following 
induction. 
 
Analytical Plan 
 
In preparation for this study, we obtained pilot data using five patients in each of the three 
proposed study arms.  As shown in Table 2, lidocaine and esmolol both decreased the incidence 
of propofol injection pain in relation to placebo.  Given that 40% (95% CI 0-83%) and 60% 
(95% CI 17-100%) patients given lidocaine and esmolol respectively reported little to no pain 
defined as a pain score of 0 on our propofol pain injection while 0% of patients who received 
placebo reported no pain, we used a sample size calculator for proportions with a 25% difference 
considered clinically significant, 90% power, and a 95% confidence level to determine a sample 
size of 32.  In order improve our certainty we will increase this to 50 patients per group. 
 
We will perform descriptive statistics on all demographic data. We will perform an individual 
comparison of all three groups using Pearson’s chi-square test with Bonferroni correction for 
multiple comparisons.  Other inferential statistics will be performed as necessary. 
 
 
Human Subjects Protection 
 
Subject Recruitment Methods 
Subjects will be identified through the daily review of the preanesthesia assessment clinic as well 
as the daily surgical schedule for those meeting inclusion criteria.  They will then be approached 
by a member of the research staff regarding their participation.   
 
Informed Consent 
Written informed consent will be obtained by a member of the research staff discussing this 
study in depth with them.  Adequate time will be given for the subject to consider their 
participation.  The risk of harm or discomfort that may occur as a result of taking part in this 
research study is not expected to be more than in daily life or from routine physical or 
psychological examinations or tests.  The rights and welfare of study will be protected through 
the use of measures to maintain the confidentiality of study information.  Study results will be 
presented or published in lieu of providing individual subjects additional information regarding 
the study. 
 
 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study 
outcomes, minimizing to the fullest extent possible the collection of any information that could 
directly identify subjects, and maintaining all study information in a secure manner.  To help 
ensure subject privacy and confidentiality, only a unique study identifier will appear on the data 


 
 
LEP protocol ver 06272022 
 
 
6 
collection form.  Any collected patient identifying information corresponding to the unique study 
identifier will be maintained on a linkage file, store separately from the data.  The linkage file 
will be kept secure, with access limited to designated study personnel.  Following data collection 
subject identifying information will be destroyed per institutional guidelines (investigator 
initiated research data maintained for 6 years) consistent with data validation and study design, 
producing an anonymous analytical data set.  Data access will be limited to study staff.  Data and 
records will be kept locked and secured, with any computer data password protected.  No 
reference to any individual participant will appear in reports, presentations, or publications that 
may arise from the study. 
 
Data and Safety Monitoring 
The principal investigator will be responsible for the overall monitoring of the data and safety of 
study participants.  The principal investigator will be assisted by other members of the study 
staff.  Wes Templeton will serve as a project mentor and will be involved in planning the study, 
navigating the IRB process, collecting and analyzing data, and preparing and submitting the 
manuscript. 
 
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol 
changes will be promptly reported by the principal investigator or designated member of the 
research team to the IRB and sponsor or appropriate government agency if appropriate. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
LEP protocol ver 06272022 
 
 
7 
References 
 
1. Tan CH, Onsiong MK: Pain on injection of propofol. Anaesthesia 1998; 53:468-76. 
2. Desousa KA: Pain on propofol injection: causes and remedies. Indian J Pharmacol 2016; 48:617-
23. 
3. Ewart MC, Whitwam JG: Prevention of pain during injection of propofol. Lancet 1990; 335:798-
9. 
4. Kaya S, Turhanoglu S, Karaman H, Özgün S, Basak N: Lidocaine for prevention of propofol 
injection-induced pain: a prospective, randomized double-blind, controlled study of the effect of 
duration of venous occlusion with a tourniquet in adults. Curr Ther Res Clin Exp 2008; 69:29-35. 
5. Massad IM, Abu-Ali HM, Abu-Halaweh SA, Badran IZ: Venous occlusion with lidocaine for 
preventing propofol induced pain: a prospective double-blind randomized study. Saudi Med J 
2006; 27:997-1000. 
6. Picard P, Tramèr MR: Prevention of pain on injection with propofol: a quantitative systematic 
review. Anesth Analg 2000; 90:963-9. 
7. Sasaki T, Okamura S, Kisara A, Ito M, Yogosawa K, Yagishita Y, Yogosawa T: Effect of lidocaine on 
pain caused by injection of propofol: comparison of three methods at two injection rates. J 
Anesth 1999; 13:14-6. 
8. Yaksh TL: Pharmacology of spinal adrenergic systems which modulate spinal nociceptive 
processing. Pharmacol Biochem Behav 1985; 22:845-58. 
9. Davidson EM, Doursout MF, Szmuk P, Chelly JE: Antinociceptive and cardiovascular properties of 
esmolol following formalin injection in rats. Can J Anaesth 2001; 48:59-64. 
10. Dhir R, Singh MR, Kaul TK, Tewari A, Oberoi R: Effect of intravenous esmolol on analgesic 
requirements in laparoscopic cholecystectomy. J Anaesthesiol Clin Pharmacol 2015; 31:375-9. 
11. Johansen JW, Flaishon R, Sebel PS: Esmolol reduces anesthetic requirement for skin incision 
during propofol/nitrous oxide/morphine anesthesia. Anesthesiology 1997; 86:364-71. 
12. Chia YY, Chan MH, Ko NH, Liu K: Role of -blockade in anaesthesia and postoperative pain 
management after hysterectomy. Br J Anaesth 2004; 93:799-805. 
13. White PF, Wang B, Tang J, Wender RH, Naruse R, Sloninsky A: The effect of intraoperative use of 
esmolol and nicardipine on recovery after ambulatory surgery. Anesth analg 2003; 97:1633-8. 
14. Ergıl J, Akelma FK, Özkan D, Aydin GB, Gürel A, Akinci M: Effects of pretreatment with esmolol 
and lidocaine on injection pain and rocuronium-induced withdrawal response. Turk J Med Sci 
2015; 45:959-63. 
15. Salman EA, Tıtız L, Akpek E, Arslan G: Pretreatment with a very low dose of intravenous esmolol 
reduces propofol injection pain. Agri 2013; 25:13-8. 
16. Miller DR, Martineau RJ, Wynands JE, Hill J: Bolus administration of esmolol for controlling the 
haemodynamic response to tracheal intubation: the Canadian multicentre trial. Can J Anaesth 
1991; 38:849-58. 
17. McCrirrick A, Hunter S: Pain on injection of propofol: the effect of injectate temperature. 
Anaesthesia 1990; 45:443-4. 
 
 


 
 
LEP protocol ver 06272022 
 
 
8 
 
Appendix 
Table 1. 
 
Pain score 
Degree of pain 
Response 
0 
None 
Negative response to questioning. 
1 
Mild 
Pain reported in response to questioning only, without any 
behavioral signs (withdrawal of extremity, grimacing, etc.) 
2 
Moderate 
Pain reported in response to questioning and accompanied by a 
behavioral sign OR pain reported spontaneously without 
questioning 
3 
Severe 
Strong vocal response OR spontaneous response accompanied by 
a behavioral sign 
 
 
 
 
Table 2. 
 
 
Esmolol 
Lidocaine 
Placebo 
Patients reporting pain 
2 
3 
5 
Total patients 
5 
5 
5 
Incidence of pain 
40% 
60% 
100% 
 
 

ICF_000.pdf: 
Official Title:  A Comparison of Lidocaine, Esmolol, and Placebo Without Use of a Tourniquet for 
Relieving Pain From Intravenous Administration of Propofol  
NCT04356352
IRB-Approved Date:  11/30/22


LEP ICF VER 04/29/2020
Page 1 of 8
Adult Consent Form
Department/Section of Anesthesiology
A COMPARISON OF LIDOCAINE, ESMOLOL AND PLACEBO WITHOUT USE 
OF A TOURNIQUET FOR RELIEVING PAIN FROM INTRAVENOUS 
ADMINISTRATION OF PROPOFOL
Informed Consent Form to Participate in Research
Michael Norton, MD, Principal Investigator
SUMMARY
You are invited to participate in a research study. The purpose of this research is to determine 
whether lidocaine or esmolol helps to eliminate pain from the injection of propofol that is 
administered as part of your anesthesia for your procedure when compared to not receiving any 
numbing medicine at all to help eliminate this injection pain.  You are invited to be in this study 
because you are scheduled to have surgery and will be going to sleep for your procedure.  These 
medications are normally administered to put you to sleep.  
Participation in this study will involve your discussing this research study with your anesthesia 
team as part of the process called informed consent.  On the day of your surgery you will be 
randomized like the flip of a coin to receive one of 3 potential treatments to see how well they 
prevent the pain or discomfort from the injection of the medication called propofol that is being 
used to put you to sleep.  All research studies involve some risks.  A risk to this study that you 
should be aware of are the risks of receiving the lidocaine and the esmolol.  These will be 
discussed in further detail later in this form.  There is the possibility that you may benefit from 
participation in this study if it demonstrates that one medication works better than the other.  
Your participation in this study is voluntary.  You do not have to participate in this study if you 
do not want to.  There may be other choices available to you.  Some other choices may include 
receiving the numbing medication   You will not lose any services, benefits, or rights you would 
normally have if you choose not to participate. 
The remainder of this form contains a more complete description of this study. Please read this 
description carefully. You can ask any questions if you need help deciding whether to join the 
study. The person in charge of this study is Dr. Michael Norton.  If you have questions, 
suggestions, or concerns regarding this study or you want to withdraw from the study please 
contact the principal investigator at 
. 
If you have any questions, suggestions or concerns about your rights as a volunteer in this 
research, contact the Institutional Review Board at 
 or the Research Subject 
Advocate at Wake Forest at 
.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00063576
Meeting Date Approved 11/30/2022          
Version Valid Until: 11/29/2023


LEP ICF VER 04/29/2020
Page 2 of 8
Adult Consent Form
INTRODUCTION
You are invited to be in a research study. Research studies are designed to gain scientific 
knowledge that may help other people in the future. You are being asked to take part in this 
study because you  are going to have a surgical procedure and will be receiving propofol in order 
to put you to sleep for your surgery (also called general anesthesia)  Your participation is 
voluntary. Please take your time in making your decision as to whether or not you wish to 
participate. Ask your study doctor or the study staff to explain any words or information 
contained in this informed consent document that you do not understand. You may also discuss 
the study with your friends and family.
WHY IS THIS STUDY BEING DONE?
The purpose of this research study is to determine whether the active medications of lidocaine or 
esmolol is more effective when compared to placebo, which is like sugar water and contains no 
active medication, at preventing the discomfort of receiving propofol when it is being used to put 
you to sleep for your surgery.   
Lidocaine has been approved by the US Food and Drug Administration (FDA) as its use as a 
local anesthetic (or numbing medication).  Esmolol has been approved by the US Food and Drug 
Administration (FDA) but it has not been approved for use as a local anesthetic to be used under 
these circumstances.  
In this study lidocaine and esmolol will be compared to placebo. A placebo is a substance, like a 
sugar pill, that is not thought to have any effect on your disease or condition. In this study you 
will either receive one of the active study medications, lidocaine or esmolol, or placebo which is 
not active. Placebos are used in research studies to see if the drug being studied really does have 
an effect.
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
150 people at Wake Forest Baptist Medical Center will take part in this study.  
WHAT IS INVOLVED IN THE STUDY?
You will be randomized into one of the study groups described below. Randomization means 
that you are put into a group by chance. It is like flipping a coin. You will have a one in three 
chance of being placed in any group.
You nor your anesthesia provider (the nurse anesthetist or anesthesia resident assisting in your 
care) will not know which drug you are receiving.  Your attending anesthesiologist will know the 
drug you are receiving. This is done so that a fair evaluation of results can be made. This 
information is available to the researchers if needed in an emergency.
If you take part in this study, you will arrive at the surgery center and be admitted as you to the 
holding room in preparation for your surgery as you normally would.  After you are admitted 
you will be randomized to receive either lidocaine, esmolol, or placebo as part of your surgical 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00063576
Meeting Date Approved 11/30/2022          
Version Valid Until: 11/29/2023


LEP ICF VER 04/29/2020
Page 3 of 8
Adult Consent Form
medications.  This will be administered in the operating room within 30 seconds of your 
receiving the initial dose of propofol.  After the administration of the study medication and 
propofol, you will be asked to provide a pain score based on how the medication felt as it was 
given through your IV.  You will be asked to provide a number on a scale of 0-3, with 0 being no 
pain, 1 is mild pain, 2 is moderate pain, and 3 being severe pain.  You will then receive the 
remaining propofol to put you to sleep for your surgery.  The anesthesia staff will monitor your 
blood pressure, heart rate, and oxygen saturation as would be done whether you participate in 
this research study or not.   
HOW LONG WILL I BE IN THE STUDY?
You will be in the study for the duration of your surgical procedure.  You can stop participating 
at any time. 
WHAT ARE THE RISKS OF THE STUDY?
Being in this study involves some risk to you. You should discuss the risk of being in this study 
with the study staff. Risks and side effects related to the use of the study medications are as 
follows:  
Lidocaine:  Potential side effects of receiving lidocaine as a local anesthetic include:

Nausea  (uncommon and mild)

Dizziness (uncommon and mild)

Numbness in places where medication is applied (common as this is a local anesthetic 
and mild)          

Redness or itching where medication is injected (common and mild)
These side effects last less than 30 minutes after injection.  There is also remote chance of 
bruising (due to the needle piercing the skin and varies on length of time it is present based on 
each individual. 
Esmolol: This drug is approved to treat irregular heartbeat or high blood pressure.  When 
Esmolol is given for these conditions it is used at a higher dose and over a longer period of time 
than as will be given to you in this study. When used as approved, the side effects of Esmolol 
are:

Low blood pressure (common and mild)

Nausea (common and mild)

Sleepiness (common and mild )

Confusion ( common and mild)

Anxiety (common and mild )

Headaches (common and mild)
These side effects are generally temporary because esmolol is a short-acting medication (the 
effects of the drug do not last long in the body).  
We do not know the side effects of using Esmolol as a local anesthetic in preventing pain along 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00063576
Meeting Date Approved 11/30/2022          
Version Valid Until: 11/29/2023


LEP ICF VER 04/29/2020
Page 4 of 8
Adult Consent Form
with propofol.  Because of this, you will be closely monitored for any side effects that may 
occur.
In addition, there is a slight risk of a breach of confidentiality.  We will do our best to protect 
your confidential information.  There also may be other risks that we cannot predict. You should 
tell the research staff about all the medications, vitamins and supplements you take and any 
medical conditions you have. This may help avoid side effects, interactions and other risks.
If you are randomized to receive a placebo, you may experience more discomfort from the 
propofol being administered than you would should you receive either lidocaine or esmolol.  
The risk of harm or discomfort that may happen as a result of taking part in this research study is 
not expected to be more than in daily life or from routine physical or psychological examinations 
or tests.  You should discuss the risk of being in this study with the study staff.
Taking part in this research study may involve providing information that you consider 
confidential or private.  Efforts, such as coding research records, keeping research records secure 
and allowing only authorized people to have access to research records, will be made to keep 
your information safe.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
In previous studies both lidocaine and esmolol have been shown to decrease the injection site 
pain associated with using propofol as your anesthesia medication to put you to sleep for your 
procedure.  If you agree to take part in this study, you may or may not have decreased injection 
site pain when you are being put to sleep. We also hope the information learned from this study 
will benefit other people in the future by showing that using one of these medications works 
better than the other one in helping to alleviate the discomfort of the administration of the 
propofol.  
WHAT OTHER CHOICES ARE THERE?
You do not have to be in this study to receive treatment. You should talk to your doctor about all 
the choices you have. Instead of being in this study, you have these options:  having your surgery 
and receiving the normal medications as would any other surgery patient, which may include the 
use of one of these medications to help alleviate the discomfort of receiving the propofol to put 
you to sleep for your surgery.  You could be treated with either lidocaine or esmolol to help 
eliminate the discomfort of the propofol administration even if you do not take part in the study.
WHAT ARE THE COSTS?
All study costs, including any study medications and procedures related directly to the study, will 
be paid for by the study. Costs for your regular medical care, which are not related to this study, 
will be your own responsibility.
WILL YOUR RESEARCH RECORDS BE CONFIDENTIAL?
The results of this research study may be presented at scientific or medical meetings or published 
in scientific journals.  Your identity and/or your personal health information will not be disclosed 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00063576
Meeting Date Approved 11/30/2022          
Version Valid Until: 11/29/2023


LEP ICF VER 04/29/2020
Page 5 of 8
Adult Consent Form
unless it is authorized by you, required by law, or necessary to protect the safety of yourself or 
others.  There is always some risk that even de-identified information might be re-identified. 
Participant information may be provided to Federal and other regulatory agencies as required.  
The Food and Drug Administration (FDA), for example, may inspect research records and learn 
your identity if this study falls within its jurisdiction.
WILL YOU BE PAID FOR PARTICIPATING?
You will receive no payment or other compensation for taking part in this study.
WHO IS SPONSORING THIS STUDY?
This study is being sponsored by the Department of Anesthesiology, Wake Forest University 
Health Sciences to cover the costs of the study medications being used.  The researchers do not, 
however, hold a direct financial interest in the sponsor or the product being studied.
WHAT HAPPENS IF YOU EXPERIENCE AN INJURY OR ILLNESS AS A 
RESULT OF PARTICIPATING IN THIS STUDY?
Should you experience a physical injury or illness as a direct result of your participation in this 
study, Wake Forest University School of Medicine maintains limited research insurance 
coverage for the usual and customary medical fees for reasonable and necessary treatment of 
such injuries or illnesses. To the extent research insurance coverage is available under this policy 
the reasonable costs of these necessary medical services will be paid, up to a maximum of 
$25,000. Wake Forest University Baptist Medical Center holds the insurance policy for this 
coverage. It provides a maximum of $25,000 coverage for each claim and is limited to a total of 
$250,000 for all claims in any one year. The Wake Forest University School of Medicine, and 
the North Carolina Baptist Hospitals, Incorporated do not assume responsibility to pay for these 
medical services or to provide any other compensation for such injury or illness. Additional 
information may be obtained from the Medical Center’s Director of Risk and Insurance 
Management, at 
.
If you are injured, the insurer may require information such as your name, social security 
number, and date of birth in order to pay for your care.  This is because the insurer is required by 
law to report any payments made to cover the care of any persons who are members of a 
government insurance plan to the Department of Health and Human Services.
You do not give up any legal rights as a research participant by signing this consent form. For 
more information on medical treatment for research related injuries or to report a study related 
illness, adverse event, or injury you should call Dr. Michael Norton at 
 during 
regular business hours, or
 after hours.
WHAT ABOUT MY HEALTH INFORMATION?
In this research study, any information we collect from you or your medical record about your 
health or behaviors is considered Protected Health Information. If this research study involves 
the diagnosis or treatment of a medical condition, then Protected Health Information collected 
from you during this study may be placed in your medical record, and may be used to help treat 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00063576
Meeting Date Approved 11/30/2022          
Version Valid Until: 11/29/2023


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you, arrange payment for your care, or assist with Medical Center operations. We will make 
every effort to keep your Protected Health Information private. We will store records of your 
Protected Health Information in a cabinet in a locked office or on a password protected 
computer. 
Your personal health information and information that identifies you (“your health information”) 
may be given to others during and after the study. This is for reasons such as to carry out the 
study, to determine the results of the study, to make sure the study is being done correctly, to 
provide required reports and to get approval for new products.  
Some of the people, agencies and businesses that may receive and use your health information 
are the research sponsor; representatives of the sponsor assisting with the research; investigators 
at other sites who are assisting with the research; central laboratories, reading centers or analysis 
centers; the Institutional Review Board; representatives of Wake Forest University Health 
Sciences and North Carolina Baptist Hospital; representatives from government agencies such as 
the Food and Drug Administration (FDA) or the Office of Human Research Protections (OHRP), 
the Department of Health and Human Services (DHHS) and similar agencies in other countries.  
Some of these people, agencies and businesses may further disclose your health information. If 
disclosed by them, your health information may no longer be covered by federal or state privacy 
regulations.  Your health information may be disclosed if required by law. Your health 
information may be used to create information that does not directly identify you. This 
information may be used by other researchers. You will not be directly identified in any 
publication or presentation that may result from this study unless there are photographs or 
recorded media which are identifiable.
Monitors, auditors, IRB or other regulatory agencies will be granted direct access to the 
participant’s original medical record for verification of clinical trial procedures or data, without 
violating confidentiality of the participant and to the extent permitted by other applicable laws.  
If required by law or court order, we might also have to share your Protected Health Information 
with a judge, law enforcement officer, government agencies, or others. If your Protected Health 
Information is shared with any of these groups it may no longer be protected by federal or state 
privacy rules.  Any Protected Health Information collected from you in this study that is 
maintained in the research records will be kept for at least six years after the study is finished.  
After that the research information will be destroyed.  
You can tell Dr. Norton that you want to take away your permission to use and share your 
Protected Health Information at any time by sending a letter to this address:
Dr. Michael Norton
However, if you take away permission to use your Protected Health Information you will not be 
able to be in the study any longer. We will stop collecting any more information about you, but 
any information we have already collected can still be used for the purposes of the research 
study.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00063576
Meeting Date Approved 11/30/2022          
Version Valid Until: 11/29/2023


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By signing this form you give us permission to use your Protected Health Information for this 
study.
If you choose to participate in this study, your medical record at Wake Forest University Baptist 
Medical Center will indicate that you are enrolled in a clinical trial.  Information about the 
research and any medications or devices you are being given as a participant may also be 
included in your medical record.  This part of the medical record will only be available to people 
who have authorized access to your medical record.  If you are not a patient at this Medical 
Center, a medical record will be created for you anyway to ensure that this important information 
is available to doctors in case of an emergency.
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 this Web site at any time. 
WHAT ARE MY RIGHTS AS A RESEARCH STUDY PARTICIPANT?
Taking part in this study is voluntary. You may choose not to take part or you may leave the 
study at any time. Refusing to participate or leaving the study will not result in any penalty or 
loss of benefits to which you are entitled. If you decide to stop participating in the study we 
encourage you to talk to the investigators or study staff first to learn about any potential health or 
safety consequences. The investigators also have the right to stop your participation in the study 
at any time. This could be because it is shown it would be in your best medical interest, your 
condition indicates it would be best if you did not participate, you have an unexpected reaction, 
or other indication.  Information that identifies you may be removed from the data or specimens 
that are collected as part of this study and could be used for future research or shared with others 
without additional consent. 
You will be given any new information we become aware of that would affect your willingness 
to continue to participate in the study.
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
For questions about the study or in the event of a research-related injury, contact the study 
investigator, Dr. Michael Norton at 
 or 
 after hours.  
The Institutional Review Board (IRB) is a group of people who review the research to protect 
your rights. If you have a question about your rights as a research participant, or you would like 
to discuss problems or concerns, have questions or want to offer input, or you want to obtain 
additional information, you should contact the Chairman of the IRB at 
 or the 
Research Subject Advocate at 
.You will be given a copy of this signed consent 
form. 
SIGNATURES
I agree to take part in this study. I authorize the use and disclosure of my health information as 
described in this consent and authorization form.  If I have not already received a copy of the 
Privacy Notice, I may request one or one will be made available to me.  I have had a chance to 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00063576
Meeting Date Approved 11/30/2022          
Version Valid Until: 11/29/2023


LEP ICF VER 04/29/2020
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Adult Consent Form
ask questions about being in this study and have those questions answered.   By signing this 
consent and authorization form, I am not releasing or agreeing to release the investigator, the 
sponsor, the institution or its agents from liability for negligence.
Subject Name (Printed):_____________________________
Subject Signature: _________________________________ Date: ________Time:_______ am pm 
Person Obtaining Consent (Printed):_____________________________
Person Obtaining Consent:___________________________ Date:_________ Time:________ am pm
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00063576
Meeting Date Approved 11/30/2022          
Version Valid Until: 11/29/2023