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CompletedNCT04187196Updated Nov 13, 2023Results posted

Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion

A Phase 4 interventional study of Propofol and Methohexital in Atrial Fibrillation and Atrial Flutter, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-13.

Sponsored by Wake Forest University Health Sciences · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
73
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Atrial Fibrillation
  • Atrial Flutter

Keywords

  • Cardioversion
  • Propofol
  • Deep sedation
  • Intravenous anesthetics
03

In context

Atrial Fibrillation

3,869 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.

This study's enrollment of 73 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients 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

Exclusion Criteria:

  • Patients with sedation for transesophageal echocardiogram within 30 minutes of DCCV
  • Hemodynamically compromised patients (as defined by hypotension \<90/50 mmHg, altered mental status, shock, ischemic chest discomfort, or heart failure)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
73 participants (actual)

Study arms

  • Experimental
    Sedation with propofol group

    Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.

    Drug: Propofol

  • Experimental
    Sedation with methohexital group

    Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.

    Drug: Methohexital

Interventions

  • DrugPropofol

    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

    Also known as: Diprivan

  • DrugMethohexital

    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

    Also known as: Brevital, Brietal

06

What researchers measure

Primary outcomes

  1. Time From Initiation of Sedation to Full Recovery

    The time from initiation of sedation to full recovery Ramsay Sedation Scale (RSS) of 2 (RSS 2 means awake; cooperative, oriented, and tranquil.)-- as evidenced by the ability to answer the questions "What is your name and what is your age?" The timer will start at the initiation of induction. Recorded in minutes.

    Time frame: Day 1

Secondary outcomes

  1. Time From End of Injection to Loss of Conscious

    Recorded in minutes.

    Time frame: Day 1

  2. Time to First Electrical Direct-current Shock

    Recorded in seconds.

    Time frame: Day 1

  3. Time to Eyes Opening

    Recorded in seconds.

    Time frame: Day 1

  4. Systolic Blood Pressure

    Time frame: Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversion

  5. Diastolic Blood Pressure

    Time frame: Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversion

  6. Mean Arterial Blood Pressure

    Time frame: Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversion

  7. Respiratory Rate

    Time frame: Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversion

  8. Saturation of Peripheral Oxygen (SpO2)

    Time frame: Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversion

  9. Heart Rate

    Time frame: Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversion

  10. Recall of Pain at Injection Site - Visual Analog Scale

    These are 100 mm lines that are anchored with "no pain" on one end and "worst imaginable pain" on the other end. Total range 0-100, higher numbers correspond to worse pain.

    Time frame: Day 1

  11. Recall of Anything Unpleasant About the Procedure - Visual Analog Scale

    These are 100 mm lines that are anchored with "no distress" on one end and "worst imaginable distress" on the other end. Total range 0-100, higher numbers correspond to worse distress.

    Time frame: Day 1

07

Results

Posted Nov 13, 2023

Participant flow

Participant flow — Overall Study
MilestoneSedation With Propofol GroupSedation With Methohexital Group
Started3538
Completed3338
Not completed20
Withdrew: Screen failure20

Outcome measures

PrimaryTime From Initiation of Sedation to Full Recovery

The time from initiation of sedation to full recovery Ramsay Sedation Scale (RSS) of 2 (RSS 2 means awake; cooperative, oriented, and tranquil.)-- as evidenced by the ability to answer the questions "What is your name and what is your age?" The timer will start at the initiation of induction. Recorded in minutes.

Time frame:
Day 1
Reported as:
Median · minutes
Time From Initiation of Sedation to Full Recovery
minutesSedation With Propofol GroupSedation With Methohexital Group
Time From Initiation of Sedation to Full Recovery7.6 (6.5 to 9.8)5.5 (4.0 to 6.9)
SecondaryTime From End of Injection to Loss of Conscious

Recorded in minutes.

Time frame:
Day 1
Reported as:
Median · minutes
Time From End of Injection to Loss of Conscious
minutesSedation With Propofol GroupSedation With Methohexital Group
Time From End of Injection to Loss of Conscious1.0 (0.8 to 1.3)1.0 (0.8 to 1.3)
SecondaryTime to First Electrical Direct-current Shock

Recorded in seconds.

Time frame:
Day 1
Reported as:
Median · seconds
Time to First Electrical Direct-current Shock
secondsSedation With Propofol GroupSedation With Methohexital Group
Time to First Electrical Direct-current Shock1.28 (0.8 to 3.3)1.2 (1.0 to 1.7)
SecondaryTime to Eyes Opening

Recorded in seconds.

Time frame:
Day 1
Reported as:
Median · seconds
Time to Eyes Opening
secondsSedation With Propofol GroupSedation With Methohexital Group
Time to Eyes Opening7.0 (5.7 to 9.6)4.2 (3.3 to 6.4)
SecondarySystolic Blood Pressure
Time frame:
Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversion
Reported as:
Median · mmHg
Systolic Blood Pressure
mmHgSedation With Propofol GroupSedation With Methohexital Group
at induction132 (125.5 to 146)140 (132 to 151.3)
prior to first shock138 (125 to 148)144 (130 to 153)
1 minute after first cardioversion124 (107 to 139.5)132 (121.8 to 155.3)
3 minutes after first cardioversion122 (106.5 to 131.5)140.5 (124 to 157.5)
5 minutes after first cardioversion114 (106 to 126)142.5 (124.8 to 158.3)
7 minutes after first cardioversion111 (101 to 122)139.5 (123.3 to 151)
9 minutes after first cardioversion111 (96 to 129)131 (120 to 143.3)
10 minutes after first cardioversion113 (94.5 to 123)136 (123.8 to 141.3)
15 minutes after first cardioversion113 (99.3 to 122.8)131 (115.5 to 141.5)
20 minutes after first cardioversion116 (101.3 to 127.8)127 (118 to 137)
SecondaryDiastolic Blood Pressure
Time frame:
Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversion
Reported as:
Median · mmHg
Diastolic Blood Pressure
mmHgSedation With Propofol GroupSedation With Methohexital Group
at induction78 (67.5 to 98.5)79.5 (71 to 93)
prior to first shock82 (69 to 96)81.5 (72 to 91.5)
1 minute after first cardioversion70 (58.5 to 83.5)76 (67.8 to 89.3)
3 minutes after first cardioversion65 (59.5 to 75.5)74 (66.8 to 82)
5 minutes after first cardioversion65 (57 to 75.5)73 (69.3 to 79)
7 minutes after first cardioversion63 (56.5 to 71)72 (66.5 to 78)
9 minutes after first cardioversion60 (56 to 72.5)68 (63 to 74.3)
10 minutes after first cardioversion67 (57 to 73)68 (63 to 74)
15 minutes after first cardioversion65 (56.5 to 76.8)69 (62.5 to 74.5)
20 minutes after first cardioversion66 (56.5 to 73)66 (61 to 76.5)
30 minutes after first cardioversion67 (59.3 to 75.8)67 (61 to 73)
SecondaryMean Arterial Blood Pressure
Time frame:
Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversion
Reported as:
Median · mmHg
Mean Arterial Blood Pressure
mmHgSedation With Propofol GroupSedation With Methohexital Group
at induction104 (91 to 113)104.5 (96.5 to 118.3)
prior to first shock102 (91.5 to 117.5)104.5 (92.8 to 115)
1 minute after first cardioversion91 (74 to 104)101.5 (90.5 to 110)
3 minutes after first cardioversion86 (80.5 to 96.5)104 (89.8 to 109.8)
5 minutes after first cardioversion84 (78 to 96)101 (91 to 112.3)
7 minutes after first cardioversion81 (72.5 to 91.5)99.5 (88 to 106.3)
9 minutes after first cardioversion81 (72 to 93)95 (85.8 to 102)
10 minutes after first cardioversion84 (72.5 to 92.5)94 (88.3 to 100)
15 minutes after first cardioversion85 (76 to 92.8)92 (84.5 to 99)
20 minutes after first cardioversion86 (75.3 to 91.5)92 (85 to 98)
30 minutes after first cardioversion87 (78.8 to 106.1)93 (85.5 to 99.5)
SecondaryRespiratory Rate
Time frame:
Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversion
Reported as:
Median · number of breaths per minute
Respiratory Rate
number of breaths per minuteSedation With Propofol GroupSedation With Methohexital Group
at induction16 (12.5 to 20)16.5 (14 to 21.3)
prior to first shock18 (13.5 to 21.5)16.5 (14.8 to 23)
1 minute after first cardioversion17 (11 to 22)17 (12.8 to 22)
3 minutes after first cardioversion19 (15 to 22.5)19.5 (17 to 22.3)
5 minutes after first cardioversion19 (16 to 22.5)18.5 (16 to 22.3)
7 minutes after first cardioversion19 (15.5 to 22)19.5 (15 to 22)
9 minutes after first cardioversion18 (15.5 to 22.5)17 (15 to 21.5)
10 minutes after first cardioversion18 (15.5 to 21.5)18 (13.5 to 22.3)
15 minutes after first cardioversion18 (13 to 22)17 (15 to 20.5)
20 minutes after first cardioversion17 (15 to 20)18 (15 to 21)
30 minutes after first cardioversion18 (16 to 20)18 (15 to 20.5)
SecondarySaturation of Peripheral Oxygen (SpO2)
Time frame:
Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversion
Reported as:
Median · percentage of oxygen saturation
Saturation of Peripheral Oxygen (SpO2)
percentage of oxygen saturationSedation With Propofol GroupSedation With Methohexital Group
at induction100 (99 to 100)100 (99 to 100)
prior to first shock100 (99.5 to 100)100 (100 to 100)
1 minute after first cardioversion98 (97 to 100)99.5 (97.8 to 100)
3 minutes after first cardioversion99 (97.5 to 100)100 (98.8 to 100)
5 minutes after first cardioversion99 (99 to 100)100 (99 to 100)
7 minutes after first cardioversion99 (99 to 100)100 (99 to 100)
9 minutes after first cardioversion100 (99 to 100)100 (99 to 100)
10 minutes after first cardioversion100 (98 to 100)100 (98 to 100)
15 minutes after first cardioversion100 (98 to 100)100 (98 to 100)
20 minutes after first cardioversion99 (98 to 100)99 (98 to 100)
30 minutes after first cardioversion98 (97 to 100)98 (96.5 to 99.5)
SecondaryHeart Rate
Time frame:
Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversion
Reported as:
Median · beats per minute
Heart Rate
beats per minuteSedation With Propofol GroupSedation With Methohexital Group
at induction96 (79 to 115)93 (77 to 128)
prior to first shock100 (84.5 to 118.5)92 (75.8 to 122)
1 minute after first cardioversion69 (62.5 to 78)73.5 (66 to 84.3)
3 minutes after first cardioversion66 (60 to 76.5)73.5 (62.5 to 84.5)
5 minutes after first cardioversion69 (61 to 74)69 (60.8 to 81.3)
7 minutes after first cardioversion66 (59.5 to 71.5)69 (59.8 to 78.3)
9 minutes after first cardioversion65 (59 to 73)67.5 (60.8 to 78.3)
10 minutes after first cardioversion64 (58 to 74)68 (59.5 to 79.3)
15 minutes after first cardioversion64.5 (59 to 72.5)68 (59.5 to 77.5)
20 minutes after first cardioversion62.5 (58.3 to 72)68 (59.5 to 74.5)
30 minutes after first cardioversion65.5 (61 to 72.3)69 (60 to 75.5)
SecondaryRecall of Pain at Injection Site - Visual Analog Scale

These are 100 mm lines that are anchored with "no pain" on one end and "worst imaginable pain" on the other end. Total range 0-100, higher numbers correspond to worse pain.

Time frame:
Day 1
Reported as:
Median · score on a scale
Recall of Pain at Injection Site - Visual Analog Scale
score on a scaleSedation With Propofol GroupSedation With Methohexital Group
Recall of Pain at Injection Site - Visual Analog Scale8 (1 to 46)2 (0 to 11.5)
SecondaryRecall of Anything Unpleasant About the Procedure - Visual Analog Scale

These are 100 mm lines that are anchored with "no distress" on one end and "worst imaginable distress" on the other end. Total range 0-100, higher numbers correspond to worse distress.

Time frame:
Day 1
Reported as:
Median · score on a scale
Recall of Anything Unpleasant About the Procedure - Visual Analog Scale
score on a scaleSedation With Propofol GroupSedation With Methohexital Group
Recall of Anything Unpleasant About the Procedure - Visual Analog Scale3 (0 to 19)1 (0 to 12.5)

Adverse events

Collected over Baseline through the end of study (approximately 1 day). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sedation With Propofol Group0/33 (0%)1/33 (3%)14/33 (42.4%)
Sedation With Methohexital Group0/38 (0%)0/38 (0%)24/38 (63.2%)
Most frequent serious events
Most frequent serious events
EventSedation With Propofol GroupSedation With Methohexital Group
Severe Oxygen Desaturation (<75% or <90% at 60s)Respiratory, thoracic and mediastinal disorders1/330/38
Most frequent other events
Most frequent other events
EventSedation With Propofol GroupSedation With Methohexital Group
HypotensionCardiac disorders14/334/38
Jaw thrust or chin liftMusculoskeletal and connective tissue disorders14/336/38
BradycardiaCardiac disorders11/3312/38
Apnea >20 secondsRespiratory, thoracic and mediastinal disorders10/336/38
HypoxemiaSocial circumstances5/330/38

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Sedation With Propofol GroupSedation With Methohexital GroupTotal
<=18 years000
Between 18 and 65 years10717
>=65 years233154
Sex: Female, Male
Sex: Female, Male(Participants)Sedation With Propofol GroupSedation With Methohexital GroupTotal
Female131629
Male202242
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Sedation With Propofol GroupSedation With Methohexital GroupTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American358
White000
More than one race000
Unknown or Not Reported303363
Region of Enrollment
Region of Enrollment(participants)Sedation With Propofol GroupSedation With Methohexital GroupTotal
United States333871
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)Sedation With Propofol GroupSedation With Methohexital GroupTotal
Median30.7 (26.1 to 36.6)30.8 (26.6 to 36.3)30.7 (26.3 to 36.4)
CHA2 DS2-VASc Congestive heart failure, Hypertension, Diabetes mellitus, prior Stroke
CHA2 DS2-VASc Congestive heart failure, Hypertension, Diabetes mellitus, prior Stroke(score on a scale)Sedation With Propofol GroupSedation With Methohexital GroupTotal
Median3 (2 to 4.5)3 (2.8 to 5.0)3 (2 to 5)
HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history
HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history(score on a scale)Sedation With Propofol GroupSedation With Methohexital GroupTotal
Median2 (1 to 3)2 (1 to 3)2 (1 to 3)
Left Atrium (LA) Diameter
Left Atrium (LA) Diameter(cm)Sedation With Propofol GroupSedation With Methohexital GroupTotal
Median4.3 (3.9 to 4.6)4.3 (3.8 to 5.2)4.3 (3.9 to 4.9)

17 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Wake Forest Baptist Medical Center
    Winston-Salem, North Carolina 27157, United States
09

References and documents

Publications

  • Beaty EH, Fernando RJ, Jacobs ML, Winter GG, Bulla C, Singleton MJ, Patel NJ, Bradford NS, Bhave PD, Royster RL. Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion. J Am Heart Assoc. 2022 Oct 4;11(19):e026198. doi: 10.1161/JAHA.122.026198. Epub 2022 Sep 21. PubMed 36129031 ↗

Study documents

  • Protocol and statistical analysis plan · Aug 26, 2020
  • Informed consent form · Dec 9, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04187196
Lead sponsor
Wake Forest University Health Sciences
Responsible party
Sponsor
First posted
Dec 5, 2019
Start date
Apr 29, 2020
Primary completion
Sep 28, 2022
Completion
Sep 28, 2022
Results posted
Nov 13, 2023
Last update
Nov 13, 2023

Study contacts

Elijah Beaty, MD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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