Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Secondary Hypothesis:
1. There will be no significant increase in adverse events associated with the use of methohexital when compared with propofol.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sedation with propofol group | Experimental | Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion. |
|
| Sedation with methohexital group | Experimental | Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Time From End of Injection to Loss of Conscious | Recorded in minutes. | Day 1 |
| Time to First Electrical Direct-current Shock | Recorded in seconds. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elijah Beaty, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36129031 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sedation With Propofol Group | Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion. Propofol: 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 |
| FG001 | Sedation With Methohexital Group | Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion. Methohexital: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sedation With Propofol Group | Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion. Propofol: 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | minutes | Day 1 |
|
Baseline through the end of study (approximately 1 day)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sedation With Propofol Group | Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion. Propofol: 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Oxygen Desaturation (<75% or <90% at 60s) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elijah Beaty, MD, MPH, FACC | Atrium Health | 704-403-6100 | Elijah.Beaty@atriumhealth.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 26, 2020 | Oct 11, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 9, 2020 | Dec 4, 2022 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D015742 | Propofol |
| D008723 | Methohexital |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Methohexital | Drug | 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 |
|
|
| Day 1 |
| Time to Eyes Opening | Recorded in seconds. | Day 1 |
| Systolic Blood Pressure | 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 |
| Diastolic Blood Pressure | 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 |
| Mean Arterial Blood Pressure | 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 |
| Respiratory Rate | 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 |
| Saturation of Peripheral Oxygen (SpO2) | 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 |
| Heart Rate | 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 |
| 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. | Day 1 |
| 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. | Day 1 |
| Sedation With Methohexital Group |
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion. Methohexital: 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Median | Inter-Quartile Range | kg/m^2 |
|
| CHA2 DS2-VASc Congestive heart failure, Hypertension, Diabetes mellitus, prior Stroke | congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female)(CHA2 DS2-VASc ); a score of 0 is "low" risk of stroke, 1 is "moderate", and any score above 1 is a "high" risk - scores range from 0-4 with 4 meaning higher risk of stroke | Median | Inter-Quartile Range | score on a scale |
|
| HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history | HAS-BLED is an acronym of the major factors associated with bleeding risk: Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile International Normalized Ratio (INR), Elderly, Drugs or alcohol; The score predicts major bleeding risk. Score is between 0 and 9 score of ≥ 3 indicates a high risk of bleeding. | Median | Inter-Quartile Range | score on a scale |
|
| Left Atrium (LA) Diameter | Median | Inter-Quartile Range | cm |
|
| Left Ventricle ejection fraction (LVEF) | Ejection fraction refers to how well your heart pumps blood. It is the amount of blood pumped out of your heart's lower chambers (ventricles) each time it contracts. An ejection fraction in a healthy heart is 50% to 70% | Median | Inter-Quartile Range | percentage of blood |
|
| Number with History of Hypertension | Count of Participants | Participants |
|
| History of heart failure with reduced ejection fraction (HFrEF) | Count of Participants | Participants |
|
| History of Transient Ischemic attack (TIA) or stroke | Count of Participants | Participants |
|
| Number with History of Diabetes | Count of Participants | Participants |
|
| Number with History of Chronic Obstructive Pulmonary Disease (COPD) | Count of Participants | Participants |
|
| Number with Thyroid Disorder | Count of Participants | Participants |
|
| Number Currently Smoking | Count of Participants | Participants |
|
| Number Drinking at Least 1 Time per Week | Count of Participants | Participants |
|
| Number of Drinkers having >2 drinks per occasion | Count of Participants | Participants |
|
| American Society of Anesthesiologists (ASA) classification III or IV | ASA classification III--someone with severe systemic disease, Substantive functional limitations. ASA classification IV--someone with a severe systemic disease that is a constant threat to life. | Count of Participants | Participants |
|
| Heart Rate | Median | Inter-Quartile Range | beats per minute (bpm) |
|
| Systolic Blood Pressure | Median | Inter-Quartile Range | mmHg |
|
| Diastolic Blood Pressure | Median | Inter-Quartile Range | mmHg |
|
| Median arterial pressure | Mean | Inter-Quartile Range | mmHg |
|
| Respiratory Rate | Median | Inter-Quartile Range | respirations per minute (rpm) |
|
| Oxygen saturation % | Median | Inter-Quartile Range | percentage of oxygen saturation |
|
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion. Methohexital: 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 |
|
|
| Secondary | Time From End of Injection to Loss of Conscious | Recorded in minutes. | Posted | Median | Inter-Quartile Range | minutes | Day 1 |
|
|
|
| Secondary | Time to First Electrical Direct-current Shock | Recorded in seconds. | Posted | Median | Inter-Quartile Range | seconds | Day 1 |
|
|
|
| Secondary | Time to Eyes Opening | Recorded in seconds. | Posted | Median | Inter-Quartile Range | seconds | Day 1 |
|
|
|
| Secondary | Systolic Blood Pressure | Posted | Median | Inter-Quartile Range | mmHg | 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 |
|
|
|
| Secondary | Diastolic Blood Pressure | Posted | Median | Inter-Quartile Range | mmHg | 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 |
|
|
|
| Secondary | Mean Arterial Blood Pressure | Posted | Median | Inter-Quartile Range | mmHg | 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 |
|
|
|
| Secondary | Respiratory Rate | Posted | Median | Inter-Quartile Range | number of breaths per minute | 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 |
|
|
|
| Secondary | Saturation of Peripheral Oxygen (SpO2) | Posted | Median | Inter-Quartile Range | percentage of oxygen saturation | 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 |
|
|
|
| Secondary | Heart Rate | Posted | Median | Inter-Quartile Range | beats per minute | 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 |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Day 1 |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Day 1 |
|
|
|
| 0 |
| 33 |
| 1 |
| 33 |
| 14 |
| 33 |
| EG001 | Sedation With Methohexital Group | Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion. Methohexital: 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 | 0 | 38 | 0 | 38 | 24 | 38 |
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Hypoxemia | Social circumstances | Systematic Assessment |
|
| Jaw thrust or chin lift | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Apnea >20 seconds | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001463 | Barbiturates |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 1 minute after first cardioversion |
|
| 3 minutes after first cardioversion |
|
| 5 minutes after first cardioversion |
|
| 7 minutes after first cardioversion |
|
| 9 minutes after first cardioversion |
|
| 10 minutes after first cardioversion |
|
| 15 minutes after first cardioversion |
|
| 20 minutes after first cardioversion |
|
| 1 minute after first cardioversion |
|
| 3 minutes after first cardioversion |
|
| 5 minutes after first cardioversion |
|
| 7 minutes after first cardioversion |
|
| 9 minutes after first cardioversion |
|
| 10 minutes after first cardioversion |
|
| 15 minutes after first cardioversion |
|
| 20 minutes after first cardioversion |
|
| 30 minutes after first cardioversion |
|
| 1 minute after first cardioversion |
|
| 3 minutes after first cardioversion |
|
| 5 minutes after first cardioversion |
|
| 7 minutes after first cardioversion |
|
| 9 minutes after first cardioversion |
|
| 10 minutes after first cardioversion |
|
| 15 minutes after first cardioversion |
|
| 20 minutes after first cardioversion |
|
| 30 minutes after first cardioversion |
|
| 1 minute after first cardioversion |
|
| 3 minutes after first cardioversion |
|
| 5 minutes after first cardioversion |
|
| 7 minutes after first cardioversion |
|
| 9 minutes after first cardioversion |
|
| 10 minutes after first cardioversion |
|
| 15 minutes after first cardioversion |
|
| 20 minutes after first cardioversion |
|
| 30 minutes after first cardioversion |
|
| 1 minute after first cardioversion |
|
| 3 minutes after first cardioversion |
|
| 5 minutes after first cardioversion |
|
| 7 minutes after first cardioversion |
|
| 9 minutes after first cardioversion |
|
| 10 minutes after first cardioversion |
|
| 15 minutes after first cardioversion |
|
| 20 minutes after first cardioversion |
|
| 30 minutes after first cardioversion |
|
| 1 minute after first cardioversion |
|
| 3 minutes after first cardioversion |
|
| 5 minutes after first cardioversion |
|
| 7 minutes after first cardioversion |
|
| 9 minutes after first cardioversion |
|
| 10 minutes after first cardioversion |
|
| 15 minutes after first cardioversion |
|
| 20 minutes after first cardioversion |
|
| 30 minutes after first cardioversion |
|