Clinical trial NCT04187196
Conditions: Atrial Fibrillation Atrial Flutter
Keywords: Cardioversion Propofol Deep sedation Intravenous anesthetics
Sponsor: Wake Forest University Health Sciences
Start date: 2020-04-29; Completion date: 2022-09-28
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized, open-blinded, prospective study to evaluate the timeliness and safety of direct current cardioversion (DCCV) when using methohexital when compared to the more often used propofol.

Detailed description:
The investigators theorize that the use of methohexital during cardioversion will result in a shorter time to effective sedation and time to full recovery when compared to the use of propofol. This will change how sedation is approached for elective cardioversions.

Primary Hypothesis:

1. The mean time to recovery from sedation during a cardioversion using methohexital for sedation will be significantly shorter than the recovery time using propofol for sedation, as evidenced by a short time from initiation of induction to a score of 2 on the Ramsay Sedation Scale.
2. The mean time to a Ramsay score of 5-6 will be significantly shorter using methohexital than the time to the same sedation level using propofol

Secondary Hypothesis:

1\. There will be no significant increase in adverse events associated with the use of methohexital when compared with propofol.

Arms: arm 1: Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion. arm 2: Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
Interventions: intervention 1: Propofol intervention 2: Methohexital
Intervention descriptions: intervention 1: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved intervention 2: Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved

Protocol documents:
Prot_SAP_000.pdf: 
Official Title:Comparison of Bolus Dosing of Methohexital and Propofol in Elective 
Direct Current Cardioversion
NCT04187196
Protocol ID:  IRB00061732
IRB-Approved Date:  8/26/2020


Protocol Version 27Aug2019 
Study Title:  Comparison of bolus dosing of methohexital and propofol in elective DC cardioversion 
Principal Investigator:  Elijah H Beaty, MD, MPH 
Co-Investigators: Roger Royster, MD; Rohesh Fernando, MD 
Sponsor/Funding Source: none 
Key words: Atrial fibrillation; Cardioversion; Methohexital; Propofol; Deep sedation; Intravenous 
anesthetics 
Background, Rationale and Context 
 
Direct current cardioversion has been in clinical use since the 1960s for the treatment of both 
atrial fibrillation and atrial flutter to restore sinus rhythm.1  By applying a QRS-synchronized current of 
energy through electrodes/pads placed on the chest wall, atrial arrhythmias can be reset and sinus 
rhythm restored.  Direct current cardioversion (DCCV) is used in both a diagnostic and a therapeutic 
fashion in the management of atrial fibrillation (AF) and atrial flutter (AFL).2  DCCV shocks are optimally 
delivered from electrodes in an anterior-posterior position, biphasic waveform, at high energy levels 
with a high acute success rate approaching 94-96%.3,4  Due to the amount of energy applied to the 
chest, a DCCV can be an uncomfortable procedure for patients who are awake.  To minimize the 
discomfort and pain, short acting, deep-sedation agents are used.5  Different medication choices are 
available for sedation during this relatively brief procedure 
 
Prior studies of deep sedation with anesthesia commonly compare propofol to other agents 
such as midazolam or etomidate.  A recent review article evaluated randomized trials of the above 
medications concluded that propofol was the best option for use in DCCV when compared to the 
others.6  The authors concluded that the hypotension and respiratory depression associated with 
propofol was acceptable when compared to the increased recovery time and risk of myoclonus of 
midazolam and etomidate, respectively.   
At our institution, a majority of DCCV are performed in the electrophysiology lab (EP lab).  
Sedation is delivered by either a CRNA under the supervision of an anesthesiologist, or by an EP lab RN 
under the direction of an electrophysiologist.  The medication choice for sedation has traditionally been 
at the discretion of the supervising physician.  The medication choices for sedation at our institution 
have historically been either propofol or methohexital.  Each medication has specific properties and 
pharmacokinetics that affect duration of action, hemodynamic changes, and respiratory depression.7 
Although these medications have been compared in other settings, such as during fracture and 
dislocation reduction in the ED,8 there are limited studies on the use of methohexital for sedation during 
cardioversion.  The largest study was a cost effectiveness cohort study of 1,473 patient undergoing an 
elective cardioversion using methohexital dosing of 0.4-0.6 mg/kg.9  Although this was a cost 
effectiveness study, the safety and cost savings lead the authors to continue to use it for their 
cardioversions.  To date there has been only one, small, randomized controlled trial comparing propofol 
and methohexital for DCCV.10  There were only 10 patients per group in this three group randomized 


Protocol Version 27Aug2019 
controlled trial.  Although it found no significant difference in the mean arterial pressure or time to 
awakening, there was a trend to quicker recovery in the patients receiving methohexital.     
We intend to perform a randomized, open-blinded, prospective study to evaluate the timeliness 
and safety of DCCVs when using methohexital when compared to the more often used propofol.  If 
there is a significant reduction in time to recovery from induction, the use of methohexital as compared 
to propofol can significantly decrease healthcare costs based on staff utilization and cost of 
medications.10 
Objectives 
 
Hypothesis: 
 
We theorize that the use of methohexital during cardioversion will result in a shorter time to 
effective sedation and time to full recovery when compared to the use of propofol.  This will change 
how sedation is approached for elective cardioversions.   
 
Primary Hypothesis: 
1. The mean time to recovery from sedation during a cardioversion using methohexital for 
sedation will be significantly shorter than the recovery time using propofol for sedation, as 
evidenced by a short time from initiation of induction to a score of 2 on the Ramsay 
Sedation Scale. 
2. The mean time to a Ramsay score of 5-6 will be significantly shorter using methohexital than 
the time to the same sedation level using propofol 
Secondary Hypothesis: 
1. There will be no significant increase in adverse events associated with the use of 
methohexital when compared with propofol.  
 
 
Methods and Measures 
Design 
We will perform a randomized, open-blinded, prospective study on all patients present for DCCV 
who meet inclusion criteria and consent to enrollment in the study.  Patients will be randomized 
to sedation with bolus dosing of either propofol or methohexital 
Setting 
This will be a single site study at a large academic medical center – Wake Forest Baptist Medical 
Center 
 


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Subjects selection criteria 
 
Inclusion Criteria 
We will select all patients over the age of 18 who present to Wake Forest Baptist Medical 
Center for a direct current cardioversion for treatment of paroxysmal or persistent atrial 
fibrillation as well as atrial flutter.   
 
 
Exclusion criteria   
Patients with sedation for transesophageal echocardiogram within 30 minutes of DCCV will 
be excluded.  Hemodynamically compromised patients (as defined by hypotension <90/50 
mmHg, altered mental status, shock, ischemic chest discomfort, or heart failure) will also be 
excluded. 
 
Sample Size  
We intend to randomize a total of 150 patients to either propofol or methohexital 
 
The following calculations have been used to establish the sample size for the full study 
According to a study evaluating bolus dosing of propofol as outlined above, the time to recovery was 
10.98 ± 2.51 min.11 
 
We will presume that a significant difference in time to recovery will be 2 minutes based on the average 
recovery time of 9 minutes when using methohexital in a small randomized controlled trial utilizing 
bolus dosing.12 
 
Estimated sample size for two-sample comparison of means 
Null hypothesis:  m1 = m2, where: m1 is the mean value in population 1 
m2 is the mean value in population 2.  Mean time to recovery from sedation with propofol is no 
different than mean time to recovery from sedation with methohexital.   
Alternative hypothesis:  m1 ≠ m2.  Mean time to recovery from sedation with propofol is different than 
mean time to recovery from sedation with methohexital 
Assumptions: 
Alpha = 0.05 (two-sided) 
Power = 0.8 
Effect size = difference in mean value of the outcome variable population 1 and population 2 = 2 
minutes  
Standardized effect size = effect size ÷ standard deviation = 2 min ÷ 2.51 min = 0.797 
 
Based on the above calculations we will need to review at least 50 patients in a 1:1 equal distribution 
between propofol and methohexital.  We will randomize 150 patients to ensure significance.    
 
Intervention and Interactions 
All patients presenting to the EP lab will be informed about the study and those who agree to participate 
will sign informed consent.   
Clinical data will be collected from electronic medical records of Wake Forest Baptist Health (WakeOne, 
Muse).  Data that are not available electronically be obtained from the patient and/or accompanying 


Protocol Version 27Aug2019 
family members.  The following clinical data will be collected: name, age, MRN, gender, ethnicity, race, 
height, weight, BMI, sodium, potassium, calcium, creatinine, creatinine clearance by Cockroft-Gault 
method, magnesium, presence or absence of antiarrhythmic medications (Na Channel blocker, Beta 
Blocker, Potassium Channel Blocker, Calcium Channel Blocker, Digoxin), CHA2DS2-VASC sore, HAS-BLED 
score, presence of Watchman device, type of anticoagulation, INR if on warfarin.  In addition to this we 
will collect parameters from the most recent echocardiogram (<1 year): Left atrial (LA) diameter, LA 
volume index, LVEDV, LVESV, EF, presence of a pre-procedure TEE.  We will include the following 
parameters from the clinical history:  HTN, HFrEF (<50%), HFpEF (>50%), prior stroke, DM, COPD, thyroid 
disorder, smoking status, drinking history, ASA Status, and Arrhythmia type.13,14 
Using the randomization tool within REDCap, our secure data storage program, stratified by sex, ASA 
status, and presence or absence of HFrEF (EF <50%), patients will be randomized to boluses of either 
methohexital or propofol.  Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg 
every minute after 2 minutes, if adequate sedation is not achieved.  Propofol will be given at an initial 
dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not 
achieved.9,15  The CRNA or anesthesiologist will draw up the pre-specified dose.  
The modified Ramsay Sedation Scale (RSS) will be used to gage the level of sedation.16  There are six 
sedation levels, three for awake and three for asleep.   Awake levels are: 1, the patient is anxious, 
agitated or restless; 2, the patient is cooperative, oriented, and tranquil; 3, the patient responds to 
verbal commands.  Asleep levels are: 4, the patient has a brisk response to a light glabellar tap or loud 
auditory stimulus; 5, sluggish response; 6, no response.  
The goal level of sedation will be a Ramsay Sedation Scale (RSS) level of 5 or 6, as evidence by either 
sluggish or no response to a glabellar tap or loud auditory stimuli, respectively.16 Due to differences in 
appearance of the medications (methohexital is clear, and propofol is milky), blinding of the 
administering personnel will prove to be difficult.    Blinding of outcome assessment will be achieved by 
obscuring both the syringe and the patient’s arm from the person collecting the information as well as 
the patient.17  Data collection personnel will be equipped with a stopwatch as well as a laptop loaded 
with REDCap to effectively record all necessary predictor and outcome variables. 
Baseline Oxygen supplementation at 4L by nasal cannula and saline administered via a peripheral IV will 
be available throughout the entire case.  Self-adhesive pads will be placed in the antero-posterior 
position on the chest.3 The patient will be given the prespecified dose of sedative.  Once adequate 
sedation is achieved the patient will receive 100 to 150 J shock for atrial flutter and 150 to 200 J shock 
using a QRS synchronized biphasic defibrillator and self-adhesive pads (Zoll R-Series Plus and Pro-Padz, 
Zoll Medical Corporation, Chelmsford, MA, USA). The protocol will allow for a maximum of 3 shocks.  If 
the initial attempt at DCCV is unsuccessful, manual pressure to the anterior pad will be allowed.   
A standard 12-lead electrocardiogram (ECG) will be obtained before sedation, and after recovery.  A 12-
lead rhythm strip will be obtained roughly 10 seconds prior to DCCV and 20 seconds after each DCCV.  
All tracings will be acquired at a paper speed of 25 mm/s and a scale of 10 mm/mV (GE MAC55, GE 
Healthcare, Chicago, IL, USA).  During the procedure, monitoring of heart rate (HR), brachial systolic 


Protocol Version 27Aug2019 
blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) respiratory rate (RR) 
and oxygen saturation (SpO2) will be measured through a mounted patient monitor (Phillips Intellivue 
MP5, Koninklijke Philips N.V, Amsterdam, Netherlands).  The above parameters will be measured at 
induction, before the shock, and every minute after the shock for the first 10 minutes, 15 minutes, 20 
minutes and 30 minutes. 
The following time intervals for the procedure will be recorded in seconds:  (T1) time from end of 
injection to loss of conscious [RSS 5-6]; (T2) Time to first shock; (T3) time to eyes opening [RSS 3]; (T4) 
Time the ability to answer simple questions of age and name [RSS 2] 
Outcome Measures 
The primary outcome to be measured will be (T4) the time from initiation of sedation to full recovery 
(RSS of 2) as evidenced by the ability to answer the questions “What is your name and what is your 
age?”16  We will start the timer at the initiation of induction.   
Secondary time based outcomes will include: (T1) time from end of injection to loss of conscious [RSS 5-
6]; (T2) Time to first shock; (T3) time to eyes opening [RSS 3].  Secondary hemodynamic outcomes will 
be vital status parameters (HR, SBP, DBP, MAP, RR, SpO2) at induction, prior to first shock, then 1, 3, 5, 
7, 9, 10, 15, 20, and 30 minutes after first cardioversion. 
Procedural parameters measured will be:  Number of DCCV, max energy used for successful DCCV, 
success of DCCV, dosage of medication (mg/kg), need for re-dosing. 
Safety endpoints will be:  evidence of bradycardia (HR <60 bpm), Hypotension (decrease in SBP ≥20%, 
hypoxemia (SpO2 nadir <85%), need for advanced airway maneuvers (jaw thrust/chin lift, or bag mask 
ventilation), apnea (respiratory arrest ≥ 20 seconds), Severity of World SIVA averse sedation event.18  
Patient experience endpoints will be measured after full recovery: recall of pain at injection site (visual 
analog scale, VAS)19, recall of anything unpleasant about the procedure (VAS).  These are 100 mm lines 
that are anchored with “no pain” or “no distress” on one end and “worst imaginable pain” or “worst 
imaginable distress” on the other end. The patient will utilize the computerized VAS within REDCap to 
mark the appropriate level.  
Variables 
Predictor Variables:  name, age, MRN, gender, ethnicity, race, height, weight, BMI, sodium, potassium, 
calcium, creatinine level, creatinine clearance, magnesium, CrCl by Cockcroft gault, presence or absence 
of antiarrhythmic medications (Na Channel blocker, Beta Blocker, Potassium Channel Blocker, Non-
dihydropyridine CCB, digoxin), CHA2DS2-VASc score, HAS-BLED score, presence of Watchman,  
anticoagulation use:  DOAC, Warfarin, ASA, Plavix, recent INR. Parameters from the most recent 
echocardiogram (<1 year): Left atrial (LA) diameter, LA volume index, LVEDV, LVESV, EF, pre-procedure 
TEE, Hypertension, congestive heart failure, stroke, diabetes, COPD, previous thyroid disorder, smoking 
status, alcohol use, ASA Status, Arrhythmia type (Atrial Fibrillation with RVR (HR >100 bpm), Atrial 


Protocol Version 27Aug2019 
Fibrillation with controlled VR (HR <100 bpm), Atrial Flutter with 2:1 block, Atrial Flutter with variable 
block), medication for sedation, final medication dose 
Outcome variables:  T1 time to LOC, T2 time to first shock, T3 time to eyes open, T4 time to recovery, 
HRinduction, HRshock, HR1, HR3, HR5, HR7, HR9, HR10, HR15, HR20, HR30, SBP (1,3…etc.), DBP 
(1,3…etc.), MAP (1,3…etc.), RR (1,3…etc.), SpO2 (1,3…etc.), NumCV, MaxEnergy, DCCVsuccess, 
MedDose(mg/kg), Redose,  
Safety measures:  Bradycardia, Hypotension, Vasopressor use, Hypoxemia, Jaw Thrust, Bag Mask, 
Invasive Airway, Apnea, SIVAseverity, PainVAS, UnpleasantVAS. 
Analytical Plan 
Continuous variables will be summarized with mean (standard deviation) or median (interquartile range) 
depending on the normality of the data and compared using student’s t-test or Wilcoxon rank-sum test, 
respectively. Categorical variables will be summarized with counts (percent) and compared using chi-
square tests. Multivariate linear regression analysis will be used to examine relationships further and 
adjust where necessary.  
Potential Limitations: 
Inability to double blind the treatment:  due to the difference in appearance between methohexital 
(clear) and propofol (milky) we are unable to blind the administrator of the medication.  However the 
researcher collecting the information and the patient will be blinded to treatment allocation by 
obscuring the patient’s arm from the patient and the sedation type from the data collector.  The 
selection of energy will be determined prior to randomization and selection for medication.  
Lack of Generalizability:  These findings will apply only to patients receiving DCCV as a separate 
procedure from a TEE.  During a TEE/DCCV induction of anesthesia is initiated prior to the TEE, which 
can last 10-20 minutes, naturally lengthening the time from induction to full recovery.  The lack of 
widespread acceptance of methohexital as an anesthetic agent in cardioversion may limit the 
adaptation of its future use as evidenced by claims in several recent review articles on sedation for 
DCCV.6,20,21  
Expected Results: 
We will identify all patients who present to the EP lab for DCCV with anesthesiology support.  We expect 
a significant difference in the time to sedation and the recovery time after induction of anesthesia with 
methohexital compared to propofol.  We also expect there to be less significant hemodynamic and 
respiratory side effects with the standard bolus dosing of methohexital vs propofol.  If proven, our 
findings will validate the widespread use of methohexital as an agent of choice for sedation for 
cardioversions.  The combination of the decreased per unit cost of methohexital and the potential of 
quicker recovery could lead to significant institutional savings.  
 


Protocol Version 27Aug2019 
Human Subjects Protection 
Subject Recruitment Methods    
Patients will be selected consecutively for participation as they present for loop implant or follow up in 
device clinic.  They will be informed of the ongoing study and will then be given an informed consent 
form to sign.  Participants will receive no compensation for participation in the study. 
 
Informed Consent 
 
Signed informed consent will be obtained from each subject. Consent will be obtained by the study 
coordinator, data collectors, and or the clinical investigators. This will occur in a quiet private holding 
area of the EP lab.  
 
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.  Study data will be collected and 
managed using REDCap electronic data capture tools hosted at Wake Forest Baptist Health.11  REDCap 
(Research Electronic Data Capture) is a secure, web-based application designed to support data capture 
for research studies, providing 1) an intuitive interface for validated data entry; 2) audit trails for tracking 
data manipulation and export procedures; 3) automated export procedures for seamless data downloads 
to common statistical packages; and 4) procedures for importing data from external sources.  To help 
ensure subject privacy and confidentiality, only a unique study identifier will appear on the data 
collection form.  Any collected patient identifying information corresponding to the unique study 
identifier will be maintained on a separate master log.  The master log will be kept secure, with access 
limited to designated study personnel.  Following data collection subject identifying information will be 
destroyed by deletion at the earliest opportunity, consistent with data validation and study design, 
producing an anonymous analytical data set.  All paper collection tools will be deposited in locked 
recycling bins located in the Wake Forest Baptist Health Heart Station.  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. 
 
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. 
 
 


Protocol Version 27Aug2019 
 
References 
1. 
Lown B, Perlroth MG, Kaidbey S, Abe T, Harken DE. "Cardioversion" of atrial fibrillation. A report 
on the treatment of 65 episodes in 50 patients. N Engl J Med 1963; 269: 325-31. 
2. 
January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the management of 
patients with atrial fibrillation: a report of the American College of Cardiology/American Heart 
Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol 2014; 
64(21): e1-76. 
3. 
Kirchhof P, Eckardt L, Loh P, et al. Anterior-posterior versus anterior-lateral electrode positions 
for external cardioversion of atrial fibrillation: a randomised trial. Lancet 2002; 360(9342): 1275-9. 
4. 
Mittal S, Ayati S, Stein KM, et al. Transthoracic cardioversion of atrial fibrillation: comparison of 
rectilinear biphasic versus damped sine wave monophasic shocks. Circulation 2000; 101(11): 1282-7. 
5. 
American Society of Anesthesiologists Task Force on S, Analgesia by N-A. Practice guidelines for 
sedation and analgesia by non-anesthesiologists. Anesthesiology 2002; 96(4): 1004-17. 
6. 
Wafae BG, da Silva RMF, Veloso HH. Propofol for sedation for direct current cardioversion. Ann 
Card Anaesth 2019; 22(2): 113-21. 
7. 
Vuyk J, Sitsen E, Reekers M. Intravenous Anesthetics. In: Miller RD, ed. Millers's Anesthesia. 
Philadelphia: Saunders, an imprint of Elsevier Inc.; 2015: 821-63.e9. 
8. 
Miner JR, Biros M, Krieg S, Johnson C, Heegaard W, Plummer D. Randomized clinical trial of 
propofol versus methohexital for procedural sedation during fracture and dislocation reduction in the 
emergency department. Acad Emerg Med 2003; 10(9): 931-7. 
9. 
Tobin MG, Pinski SL, Tchou PJ, Ching EA, Trohman RG. Cost effectiveness of administration of 
intravenous anesthetics for direct-current cardioversion by nonanesthesiologists. Am J Cardiol 1997; 
79(5): 686-8. 
10. 
Gale DW, Grissom TE, Mirenda JV. Titration of intravenous anesthetics for cardioversion: a 
comparison of propofol, methohexital, and midazolam. Crit Care Med 1993; 21(10): 1509-13. 
11. 
Desai PM, Kane D, Sarkar MS. Cardioversion: What to choose? Etomidate or propofol. Ann Card 
Anaesth 2015; 18(3): 306-11. 
12. 
Tiongson JG, Jr., Helmuth J, Austin M, Linde C. Comparison of diazepam and sodium 
methohexital in elective DC cardioversion. Del Med J 1978; 50(11): 601-3. 
13. 
Recommended Alcohol Questions. 2003. https://www.niaaa.nih.gov/research/guidelines-and-
resources/recommended-alcohol-questions (accessed October 21, 2019. 
14. 
ASA Physical Status Classification System. October 14, 2015 2014. 
https://www.asahq.org/standards-and-guidelines/asa-physical-status-classification-system (accessed 
July 15, 2019. 
15. 
Guerra F, Pavoni I, Romandini A, et al. Feasibility of a cardiologist-only approach to sedation for 
electrical cardioversion of atrial fibrillation: a randomized, open-blinded, prospective study. 
International journal of cardiology 2014; 176(3): 930-5. 
16. 
Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-
alphadolone. Br Med J 1974; 2(5920): 656-9. 
17. 
Parlak M, Parlak I, Erdur B, Ergin A, Sagiroglu E. Age effect on efficacy and side effects of two 
sedation and analgesia protocols on patients going through cardioversion: a randomized clinical trial. 
Acad Emerg Med 2006; 13(5): 493-9. 
18. 
Mason KP, Green SM, Piacevoli Q. Adverse event reporting tool to standardize the reporting and 
tracking of adverse events during procedural sedation: a consensus document from the World SIVA 
International Sedation Task Force. British Journal of Anaesthesia 2012; 108(1): 13-20. 


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19. 
DeLoach LJ, Higgins MS, Caplan AB, Stiff JL. The visual analog scale in the immediate 
postoperative period: intrasubject variability and correlation with a numeric scale. Anesth Analg 1998; 
86(1): 102-6. 
20. 
Lewis SR, Nicholson A, Reed SS, Kenth JJ, Alderson P, Smith AF. Anaesthetic and sedative agents 
used for electrical cardioversion. Cochrane Database Syst Rev 2015; (3): CD010824. 
21. 
Gerstein NS, Young A, Schulman PM, Stecker EC, Jessel PM. Sedation in the Electrophysiology 
Laboratory: A Multidisciplinary Review. Journal of the American Heart Association 2016; 5(6). 
Appendix 
1. Inclusion/Exclusion Form 
2. Demographics Form 
3. Baseline Data Form 
4. Randomization Form 
5. Cardioversion Procedure Form 
6. Cardioversion Workflow 
 


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Inclusion/Exclusion Form
Study ID
__________________________________
Inclusion Criteria
Yes
No
Age > 18 years
Consent to cardioversion
If NO to any of the above, pt is to be withdrawn from the study
Exclusion Criteria
Yes
No
Transesophageal Echo within the
past 30 minutes
Severe hypotension present
(SBP < 90 mmHg and/or DBP <
50 mmHg)
Altered Mental Status (Unable to
answer correctly to name and
place)
Ischemic Chest Discomfort
Decompensated heart failure
(Volume overload by exam)
If YES to any of the above, pt is to be withdrawn from the study
Patient Withdrawn From Study
Yes
No


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Demographics
Study ID
__________________________________
Consent Information
Date subject signed consent
__________________________________
(YYYY-MM-DD)
Contact Information
First Name
__________________________________
Last Name
__________________________________
Age
__________________________________
MRN
__________________________________
Gender
Female
Male
Ethnicity
Hispanic or Latino
NOT Hispanic or Latino
Unknown / Not Reported
Race
American Indian/Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More Than One Race
Unknown / Not Reported
Height
__________________________________
(*.*** in meters (m))
Weight
__________________________________
(***.* in kilograms (kg))
BMI
__________________________________


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Labs and Medications
Sodium
__________________________________
Potassium
__________________________________
Calcium
__________________________________
Creatinine
__________________________________
Creatinine Clearance
__________________________________
(Cockroft-Gault)
Magnesium
__________________________________
Taking Antiarrhythmic Drugs
Yes
No
If the patient answered yes to taking antiarrhythmics, which class of antiarrhythmics were
taken
Yes
No
Sodium Channel Blocker
Beta Blocker
Potassium Channel Blocker
Non-Dihydropyridine Calcium
Channel Blocker
Digoxin
CHA2DS2-VASC Score
__________________________________
(must calculate and input)
HAS-BLED Score
__________________________________
Watchman Device?
Yes
No
Anticoagulation
Direct oral anticoagulant
Warfarin
ASA
ASA/Plavix
Plavix
none
INR
__________________________________
(If on coumadin what is INR)


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Baseline Data
Study ID
__________________________________
Echocardiogram Results
Date of Echo
__________________________________
Left Atrial Diameter (cm)
__________________________________
LA Volume Index (ml/m2)
__________________________________
(**.*)
LVEDV (MOD-sp2) (ml)
__________________________________
(***.*)
LVESV (MOD-sp2) (ml)
__________________________________
(***.*)
Ejection Fraction (%)
__________________________________
(Use highest number)
Pre-Procedure TEE
Yes
No
(must have been >30 min pre DCCV)
Clinical History
HTN
Yes
No
(HTN or on meds for HTN)
HFrEF
Yes
No
(EF < 50%)
HFpEF
Yes
No
(EF > 50%)
Prior Stroke
Yes
No
Diabetes
Yes
No
COPD
Yes
No


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Thyroid Disorder
Yes
No
Do you currently smoke tobacco products?
Yes
No
During the last 12 months, how often did you usually
Every day
have any kind of drink containing alcohol? By a
5 - 6 times a week
drink we mean half an ounce of absolute alcohol
3 - 4 times a week
(e.g. a 12 ounce can or glass of beer or cooler, a 5
twice a week
ounce glass of wine, or a drink containing 1 shot of
once a week
liquor). Choose only one.
2 - 3 times a month
once a month
3 - 11 times in the past year
1 or 2 times in the past year
I did not drink any alcohol in the past year, but
I did drink in the past
I never drank any alcohol in my life
During the last 12 months, how many alcoholic drinks
25 or more drinks
did you have on a typical day when you drank alcohol?
19 to 24 drinks
16 to 18 drinks
12 to 15 drinks
9 to 11 drinks
7 to 8 drinks
5 to 6 drinks
3 to 4 drinks
2 drinks
1 drink
During the last 12 months, what is the largest number
36 drinks or more
of drinks containing alcohol that you drank within a
24 to 35 drinks
24-hour period?
18 to 23 drinks
12 to 17 drinks
8 to 11 drinks
5 to 7 drinks
4 drinks
3 drinks
2 drinks
1 drink
During the last 12 months, how often did you have 5
Every day
or more (males) or 4 or more (females) drinks
5 to 6 days a week
containing any kind of alcohol in within a two-hour
3 to 4 days a week
period? [That would be the equivalent of at least 5
two days a week
(4) 12-ounce cans or bottles of beer, 5 (4) five
one day a week
ounce glasses of wine, 5 (4) drinks each containing
2 to 3 days a month
one shot of liquor or spirits - to be provided by
one day a month
interviewer if asked.] Choose only one.
3 to 11 days in the past year
1 or 2 days in the past year


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ASA Status
ASA I Normal Healthy Patient:  Healthy,
non-smoking, no or minimal alcohol use
ASA II Mild Systemic Disease:  Mild diseases only
without substantive functional limitations.
Examples include (but not limited to): current
smoker, social alcohol drinker, pregnancy, obesity
(30 < BMI < 40), well-controlled DM/HTN, mild lung
disease
ASA III Severe Systemic Disease:  Substantive
functional limitations; One or more moderate to
severe diseases.  Examples include (but not
limited to): poorly controlled DM or HTN, COPD,
morbid obesity(BMI ≥40), active hepatitis,
alcohol dependence or abuse, implanted pacemaker,
moderate reduction of ejection fraction, ESRD
undergoing regularly scheduled dialysis, history
(>3 months) of MI,CVA, TIA, or CAD/stents
ASA IV Severe Systemic Disease That Is A Constant
Threat To Life:  Examples include (but not limited
to):  recent ( < 3months) MI, CVA, TIA, or
CAD/stents, ongoing cardiac ischemia or severe
valve dysfunction, severe reduction of ejection
fraction, sepsis, DIC, ARD or ESRD not undergoing
regularly scheduled dialysis
Arrhythmia Type
Atrial Fibrillation with RVR (HR>100 bpm)
Atrial Fibrillation with controlled VR (HR < 100
bpm)
Atrial Flutter with 2:1 Block
Atrial Flutter with variable block


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Comparison of bolus dosing of methohexital and propofol in elective DC cardioversion
Page 1 of 1
Randomization Form
Study ID
__________________________________
Randomization Form:  To be filled out by Anesthesiology, Data Collector To be Blinded
Randomization Group
Methohexital
Propofol
Total Dose Given (mg)
__________________________________
Total Dose per body weight
__________________________________
Extra Dosing Required?
Yes
No
(Methohexital: 10 mg every minute after 2 min,
Propofol 20 mg every minute after 2 minutes)
Number of Extra Doses
1
2
3
4
5


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Comparison of bolus dosing of methohexital and propofol in elective DC cardioversion
Page 1 of 6
Cardioversion Procedure
Study ID
__________________________________
Date of Cardioversion
__________________________________
Timed events during cardioversion
Start Stopwatch when  anesthesia announces bolus initiated.  Hit lap button after each time
event.
T1 - Time To LOC (RSS 5 or 6)
__________________________________
(MM:SS)
T2 - Time To First Shock
__________________________________
(MM:SS)
T3 - Time To Eyes Open
__________________________________
(MM:SS, may be to voice or touch)
T4 - Time To Recovery (Able to answer both "What is
your name and what is your age?")
__________________________________
(MM:SS)
Vitals Measurements Prior To Induction
Heart Rate
__________________________________
SBP
__________________________________
DBP
__________________________________
MAP
__________________________________
Respiratory Rate
__________________________________
SpO2 
__________________________________


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Vitals Measurements Prior to First Shock
Heart Rate
__________________________________
SBP
__________________________________
DBP
__________________________________
MAP
__________________________________
Respiratory Rate
__________________________________
SpO2
__________________________________
Vitals Measurements 1 Minute After Shock
Heart Rate
__________________________________
SBP
__________________________________
DBP
__________________________________
MAP
__________________________________
Respiratory Rate
__________________________________
SpO2
__________________________________
Vitals Measurements 3 Minutes After Shock
Heart Rate
__________________________________
SBP
__________________________________
DBP
__________________________________
MAP
__________________________________
Respiratory Rate
__________________________________


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SpO2
__________________________________
Vitals Measurements 5 Minutes After Shock
Heart Rate
__________________________________
SBP
__________________________________
DBP
__________________________________
MAP
__________________________________
Respiratory Rate
__________________________________
SpO2
__________________________________
Vitals Measurements 7 Minutes After Shock
Heart Rate
__________________________________
SBP
__________________________________
DBP
__________________________________
MAP
__________________________________
Respiratory Rate
__________________________________
SpO2
__________________________________
Vitals Measurements 9 Minutes After Shock
Heart Rate
__________________________________
SBP
__________________________________
DBP
__________________________________


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MAP
__________________________________
Respiratory Rate
__________________________________
SpO2
__________________________________
Vitals Measurements 10 Minutes After Shock
Heart Rate
__________________________________
SBP
__________________________________
DBP
__________________________________
MAP
__________________________________
Respiratory Rate
__________________________________
SpO2
__________________________________
Vitals Measurements 15 Minutes After Shock
Heart Rate
__________________________________
SBP
__________________________________
DBP
__________________________________
MAP
__________________________________
Respiratory Rate
__________________________________
SpO2
__________________________________


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Vitals Measurements 20 Minutes After Shock
Heart Rate
__________________________________
SBP
__________________________________
DBP
__________________________________
MAP
__________________________________
Respiratory Rate
__________________________________
SpO2
__________________________________
Vitals Measurements 30 Minutes After Shock
Heart Rate
__________________________________
SBP
__________________________________
DBP
__________________________________
MAP
__________________________________
Respiratory Rate
__________________________________
SpO2
__________________________________
Cardioversion Summary
Successful Cardioversion?
Yes
No
Number of Cardioversions
One
Two
Three
Maximum Energy Used
50 J
100 J
125 J
150 J
200 J


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Joules Used For Each Attempt (Answer if >1 attempt)
50 J
100 J
125 J
150 J
200 J
DCCV #1
DCCV #2
DCCV #3
Safety Endpoints
Evidence of Bradycardia
Yes
No
(HR < 60 bpm)
Hypotension
Yes
No
(Decrease in SBP >or= 20%)
Were vasopressor agents required?
Yes
No
Hypoxemia
Yes
No
(SpO2 Nadir < 85%)
Jaw Thrust or Chin Lift Required
Yes
No
Bag Mask Ventilation
Yes
No
Invasive Airway Required
Yes
No
Apnea > 20 seconds
Yes
No
World Society of Intravenous Anesthesia (World SIVA)
Minimal Risk Adverse Event
Adverse Event Severity
Minor Risk Adverse Event
Moderate Risk Adverse Event
Sentinel Adverse Event
No adverse events
(Select the most severe option from the attached
World SIVA Sheet)
Patient Experience
Recall of Pain at the Injection site
worst imaginable
no pain
pain
                                                             (Place a mark on the scale above)
Unpleasantness of the Procedure
worst imaginable
no distress
distress
                                                             (Place a mark on the scale above)


Cardioversion Workflow 
 
Patient Arrives 
 Informed Consent 
Inclusion/Exclusion 
History and Demographic Collection 

Demographic Sheet (Use Recdaps) 

Baseline Data form 
Randomization 

Anessthesia - Randomization form on 
REDCap  
 Brevital 
0.5 mg/kg (ABW) 
- May give extra 10 
mg/min after 2 min 
Propofol 
0.8 mg/kg (ABW) 
- May give extra 20 
mg/min after 2 min  
Data Collector 

Baseline Vitals 

Start Stop watch when bolus 
announced 

Record Lap Times 
T1 - Time to LOC, RSS 5 or 6 
T2 - Time to First Shock 
T3 - Type to Eyes Open (touch/voice) 
T4 - Time to recovery, Answer Name 
and Age 

Automatic BP set to q 1 min for first 
10 min then q 5 min  
Pre DCCV vitals are closest vitals prior 
to 1st DCCV 

At 30 min Recovery 
Have pt mark experience scale in 
REDCap 

Complete Siva Adverse Event Form 

Input Data into REDCap 
Anesthesiology 

Randomization form Ready 

Initiate Randomization 

Prepare Medication out of sight of pt 
and data collector 

Make verbal announcement “bolus 
starting” to prompt timer start 

Head tilt/chin lift only if Sat <90% 
 
After Cardioversion 

Record total Dose 

Input Data into Redcaps 
  
Monitor 
Defib 
RN 
Patient 
 
Arm 
Covered 
ECG 
CRNA 
Anesth 
Attd 
Data 
Collector 
Shield 
Area Setup 
Needed Items  
 
 
 
Needed Forms 
Stopwatch 
 
 
 
 
Demographics 
Clipboards 
 
 
 
 
Baseline Data 
Randomization Tool (Redcaps)  
 
Randomization 
Ruler (cm) 
 
 
 
 
Cardioversion Procedure 
Laptop for immediate data input 
 
Siva Adverse Event 
Patient Experience Form 
Consent 
Inclusion/Exclusion 


Addendum A 
Patient Contact Script (v6.02.2020) 
1. Contact Patients who have a scheduled cardioversion (found on the status board on epic) 
 
2. Good [Morning, afternoon, evening] [Mr/Ms.] [Last name]  My name is [Molly Jacobs] I am currently 
working as a recruiter and data collector for our electrophysiologists. 
 
3. At the Wake Forest Baptist Heart and Vascular Center, our electrophysiologists work collaboratively 
with cardiologists, cardiothoracic surgeons and other heart and vascular specialists to provide state-
of-the-art therapies for patients with simple to complex arrhythmias. In addition, our 
electrophysiologists are heavily involved with the latest research and clinical trials in cardiac 
electrophysiology 
 
4. Because you have an upcoming scheduled cardioversion, We would like to offer you the opportunity 
to consider volunteering to participate in one of our clinical research studies 
 
5. One of our current studies is one randomizing patients who are scheduled for cardioversions 
(without preceding TEE) to receive either propofol or brevital, two short acting medications 
currently in use during cardioversions. The Electrophysiologists and Anesthesiologists are comparing 
the two to see which one leads to a more rapid recovery.  This study does not change the end result 
we are trying to accomplish, which is to try to get you back into normal rhythm.  It will only change 
which sedation we give you.  
 
6. I just wanted to contact you ahead of time so that I may potentially answer any questions you may 
have.   
a. If no.  Ok.  We will see you at the time of your cardioversion.  Thank you and have a 
great day  [Mr/Ms.] [Last name]   
 
b. If yes.  Try to answer questions based on the attached IRB Informed consent form.  We 
will see you at the time of your cardioversion.  Thank you and have a great 
day  [Mr/Ms.] [Last name]. 
 
 


Addendum B 
Review retrospective data will be performed to evaluate what was the average Propofol dosing per kg of 
measured and ideal body weight in patients who meet the criteria of having received an elective 
cardioversion procedure with Propofol” as outlined in the PI’s i2b2 search PR CA-PR EC-Propo@10:13:58 
[5-7-2020] [ebeaty]. 

ICF_001.pdf: 
NCT04187196
Official Title: Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct 
Current Cardioversion 
    
IRB-Approved Date:  12/9/20


Page 1 of 7
Adult Consent Form
ICF Version 17DEC2020
Department of Internal Medicine, Section on Cardiovascular Medicine
COMPARISON OF BOLUS DOSING OF METHOHEXITAL 
AND PROPOFOL IN ELECTIVE DC CARDIOVERSION
Informed Consent Form to Participate in Research
Elijah Beaty, MD MPH, Principal Investigator
SUMMARY
You are invited to participate in a research study. The purpose of this research is to evaluate and 
compare the recovery time after a direct current cardioversion (DCCV) for patients sedated with 
either intravenous methohexital (Brevital) or intravenous propofol (Diprivan).  You are invited to 
be in this study because you are about to undergo a direct current cardioversion (DCCV). Your 
participation in this research will involve only the one visit on the day of your procedure.
Participation in this study will also involve EKGs.  All research studies involve some risks.  A 
risk to this study that you should be aware of 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. There is no possibility that you may benefit from 
participation in this study.  
Your participation in this study is voluntary.  You do not have to participate in this study if you 
do not want to. 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 Elijah Beaty, MD MPH. If you have questions, 
suggestions, or concerns regarding this study or you want to withdraw from the study his contact 
information is: Elijah Beaty 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 
.
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 about to undergo a direct current cardioversion (DCCV). 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 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00061732
Meeting Date Approved 12/9/2020          
Version Valid Until: 12/8/2021


Page 2 of 7
Adult Consent Form
ICF Version 17DEC2020
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 evaluate and compare the recovery time after a 
cardioversion in patients sedated with either intravenous methohexital (Brevital) or intravenous 
propofol (Diprivan).  
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
One hundred fifty people at one research site will take part in this study.  In order to identify the 
150 subjects needed, we may need to screen as many as 200 because some people will not qualify 
to be included in the study. 
WHAT IS INVOLVED IN THE STUDY?
You have a potential to be in this study because you are about to undergo a DCCV for your atrial 
arrhythmia.  Atrial arrhythmias can be classified as atrial fibrillation, atrial flutter, and atrial 
tachycardia. 
To make you comfortable for a cardioversion we use intravenous sedation medications.  At 
Wake Forest Baptist Health, sedation is delivered by our anesthesiology group.  Both 
methohexital and propofol are routinely used for sedation before cardioversion at this institution.
This study is a randomized trial. Should you choose to participate in this study, you will be 
randomized to receive sedation with one of these two study medications:

Methohexital; or 

Propofol
Randomization means that you are put into a group by chance. It is like flipping a coin. You will 
have an equal chance of being placed in any group.
This study is also “blinded”. This means you will not be told which intravenous sedation 
medication you received until after your procedure. 
Two standard 12-lead electrocardiograms (EKGs) will be obtained.  One before sedation and one 
after recovery. An EKG measures the electrical activity of your heartbeat. EKG stickers will be 
placed on your chest for the EKG machine to measure this activity.  EKG is standard practice 
during a procedure like your DCCV.
Following your DCCV, you will be asked to rate your recovery experience from and during the 
procedure on a scale provided to you by the study team. 
HOW LONG WILL I BE IN THE STUDY?
You will be in the study just for the day of your cardioversion.
You can stop participating at any time. If you decide to stop participating in the study we 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00061732
Meeting Date Approved 12/9/2020          
Version Valid Until: 12/8/2021


Page 3 of 7
Adult Consent Form
ICF Version 17DEC2020
encourage you to talk to the investigators or study staff first.  There are no potential health or 
safety consequences from not participating in the study.
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 drugs we are studying include:
Methohexital:
Common side effects of methohexital include drowsiness, nausea, vomiting, chills, 
coughing, hiccups, muscle twitching; or mild skin rash or itching. 
Propofol:
Common side effects of propofol include fast or slow heart rate, high or low blood 
pressure, rash and itching. 
This study is comparing two approved methods for treating your condition. You will be 
randomly assigned to one of the two groups. It is possible that one treatment group may have a 
better response than the other. Therefore there is a risk that you may be assigned to a group that 
does not perform as well as its comparison.
In addition, there is a slight risk of a breach of confidentiality. We will do our best to protect 
your confidential information. 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.
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.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
You are not expected to receive any direct benefit from taking part in this research study. We 
hope the information learned from this study will benefit other people in the future.  It may allow 
us to select the safest and quickest method of sedation for a cardioversion.
WHAT OTHER CHOICES ARE THERE?
Your alternative is to not participate in this study.  The selection of intravenous sedation for a 
cardioversion is up to the discretion of the attending anesthesiologist. 
WHAT ARE THE COSTS?
Taking part in this study will not lead added costs to you or your insurance company.  The costs 
of the ECG and the DCCV are part of the cardioversion procedure, independent of the study on 
sedation.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00061732
Meeting Date Approved 12/9/2020          
Version Valid Until: 12/8/2021


Page 4 of 7
Adult Consent Form
ICF Version 17DEC2020
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 
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 Wake Forest Baptist Health’s Department of Cardiovascular 
Medicine and is not funded.
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 Elijah Beaty at 
WHAT ABOUT MY HEALTH INFORMATION?
In this research study, any new information we collect from you and/or information we get from 
your medical records or other facilities about your health or behaviors is considered Protected 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00061732
Meeting Date Approved 12/9/2020          
Version Valid Until: 12/8/2021


Page 5 of 7
Adult Consent Form
ICF Version 17DEC2020
Health Information. The information we will collect for this research study includes: your name, 
medical record number, age, sex, race, height, weight, BMI, sodium, potassium, calcium, 
creatinine level, magnesium, medications, indication for cardioversion, results from your most 
recent echocardiogram and ECG.
If this research study involves the diagnosis or treatment of a medical condition, then Protected 
Health Information collected from you during this study will be placed in your medical record, 
and may be used to help treat 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. Only the following people or organizations will be granted access to your 
Protected Health Information:
1) The study investigator and his/her staff, or others at Wake Forest University Health 
Sciences who oversee research
2) Other people or laboratories providing services for this research project on behalf of 
Wake Forest University Health Sciences and Wake Forest University Baptist Medical 
Center 
3) Monitors, auditors, IRB or other regulatory agencies will be granted direct access to your 
original medical record for verification of clinical trial procedures or data, without 
violating your confidentiality 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 one year after the study is finished. At that time any 
research information not already in your medical record will either be destroyed or it will be de-
identified.  You will not be able to obtain a copy of your Protected Health Information in the 
research records until all activities in the study are completely finished. 
You can tell Elijah Beaty 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:
Elijah Beaty, MD MPH
However, if you take away permission to use your Protected Health Information you will not be 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00061732
Meeting Date Approved 12/9/2020          
Version Valid Until: 12/8/2021


Page 6 of 7
Adult Consent Form
ICF Version 17DEC2020
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.
By signing this form you give us permission to use your Protected Health Information for this 
study.
Laboratory test results and other medical reports created as a result of your participation in the 
research study may be entered into the computer systems of Wake Forest University Health 
Sciences and North Carolina Baptist Hospital.  These will be kept secure, with access to this 
information limited to individuals with proper authority, but who may not be directly involved 
with this research study.
A North Carolina Baptist Hospital (NCBH) medical record will be created for all study 
participants. Information about your participation in the study will be placed in the NCBH 
medical record, along with any routine medical test results that were obtained at NCBH as part 
of 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.  You will still receive a cardioversion and appropriate 
follow up.  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 in your best medical interest, your condition worsened, new information 
becomes available, you had an unexpected reaction, you failed to follow instructions, or because 
the entire study has been stopped. 
You will be given any new information we become aware of that would affect your willingness 
to continue to participate in the study.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00061732
Meeting Date Approved 12/9/2020          
Version Valid Until: 12/8/2021


Page 7 of 7
Adult Consent Form
ICF Version 17DEC2020
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, Elijah Beaty at 
.
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 (336) 
 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 
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:IRB00061732
Meeting Date Approved 12/9/2020          
Version Valid Until: 12/8/2021