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

Study Overview
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Brief Summary
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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
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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: 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. 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.

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

Conditions
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Atrial Fibrillation, Atrial Flutter

Intervention / Treatment
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* Drug: Propofol
* Drug: Methohexital


Participation Criteria
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Eligibility Criteria
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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: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sedation with propofol group<br>Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion. | Drug: Propofol<br>* 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<br>* Other names: Diprivan;|
| Experimental: Sedation with methohexital group<br>Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion. | Drug: Methohexital<br>* 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<br>* Other names: Brietal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardioversion, Propofol, Deep sedation, Intravenous anesthetics