Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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:
-
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:
- There will be no significant increase in adverse events associated with the use of methohexital when compared with propofol.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sedation with propofol group Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion. |
Drug: 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
Other Names:
|
| Experimental: Sedation with methohexital group Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion. |
Drug: 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
Other Names:
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Outcome Measures
Primary Outcome Measures
- Time from initiation of sedation to full recovery [Day 1]
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?" We will start the timer at the initiation of induction.Recorded in seconds.
Secondary Outcome Measures
- Time from end of injection to loss of conscious [Day 1]
Recorded in seconds.
- Time to first shock [Day 1]
Recorded in seconds.
- Time to eyes opening [Day 1]
Recorded in seconds.
- Systolic Blood Pressure [Day 1, at induction]
- Systolic Blood Pressure [Day 1, prior to first shock]
- Systolic Blood Pressure [Day 1,1 minute after first cardioversion]
- Systolic Blood Pressure [Day 1,3 minutes after first cardioversion]
- Systolic Blood Pressure [Day 1,5 minutes after first cardioversion]
- Systolic Blood Pressure [Day 1,7 minutes after first cardioversion]
- Systolic Blood Pressure [Day 1,9 minutes after first cardioversion]
- Systolic Blood Pressure [Day 1,10 minutes after first cardioversion]
- Systolic Blood Pressure [Day 1,15 minutes after first cardioversion]
- Systolic Blood Pressure [Day 1,20 minutes after first cardioversion]
- Systolic Blood Pressure [Day 1,30 minutes after first cardioversion]
- Diastolic Blood Pressure [Day 1, at induction]
- Diastolic Blood Pressure [Day 1, prior to first shock]
- Diastolic Blood Pressure [Day 1,1 minute after first cardioversion]
- Diastolic Blood Pressure [Day 1,3 minutes after first cardioversion]
- Diastolic Blood Pressure [Day 1,5 minutes after first cardioversion]
- Diastolic Blood Pressure [Day 1,7 minutes after first cardioversion]
- Diastolic Blood Pressure [Day 1,9 minutes after first cardioversion]
- Diastolic Blood Pressure [Day 1,10 minutes after first cardioversion]
- Diastolic Blood Pressure [Day 1,15 minutes after first cardioversion]
- Diastolic Blood Pressure [Day 1, 20 minutes after first cardioversion]
- Diastolic Blood Pressure [Day 1, 30 minutes after first cardioversion]
- Mean arterial Blood Pressure [Day 1, at induction]
- Mean arterial Blood Pressure [Day 1, prior to fist shock]
- Mean arterial Blood Pressure [Day 1, 1 minute after first cardioversion]
- Mean arterial Blood Pressure [Day 1, 3 minutes after first cardioversion]
- Mean arterial Blood Pressure [Day 1, 5 minutes after first cardioversion]
- Mean arterial Blood Pressure [Day 1, 7 minutes after first cardioversion]
- Mean arterial Blood Pressure [Day 1, 9 minutes after first cardioversion]
- Mean arterial Blood Pressure [Day 1, 10 minutes after first cardioversion]
- Mean arterial Blood Pressure [Day 1, 15 minutes after first cardioversion]
- Mean arterial Blood Pressure [Day 1, 20 minutes after first cardioversion]
- Mean arterial Blood Pressure [Day 1, 30 minutes after first cardioversion]
- Respiratory Rate [Day 1, prior to first shock]
- Respiratory Rate [Day 1,1 minute after first cardioversion]
- Respiratory Rate [Day 1, 3 minutes after first cardioversion]
- Respiratory Rate [Day 1, 5 minutes after first cardioversion]
- Respiratory Rate [Day 1, 7 minutes after first cardioversion]
- Respiratory Rate [Day 1, 9 minutes after first cardioversion]
- Respiratory Rate [Day 1, 10 minutes after first cardioversion]
- Respiratory Rate [Day 1, 15 minutes after first cardioversion]
- Respiratory Rate [Day 1, 20 minutes after first cardioversion]
- Respiratory Rate [Day 1, 30 minutes after first cardioversion]
- SpO2 [Day 1, at induction]
- SpO2 [Day 1, prior to first shock]
- SpO2 [Day 1, 1 minute after first cardioversion]
- SpO2 [Day 1, 3 minutes after first cardioversion]
- SpO2 [Day 1, 5 minutes after first cardioversion]
- SpO2 [Day 1, 7 minutes after first cardioversion]
- SpO2 [Day 1, 9 minutes after first cardioversion]
- SpO2 [Day 1, 10 minutes after first cardioversion]
- SpO2 [Day 1, 15 minutes after first cardioversion]
- SpO2 [Day 1, 20 minutes after first cardioversion]
- SpO2 [Day 1, 30 minutes after first cardioversion]
- Heart rate [Day 1, at induction]
- Heart rate [Day 1, prior to first shock]
- Heart rate [Day 1,1 minute after first cardioversion]
- Heart rate [Day 1, 3 minutes after first cardioversion]
- Heart rate [Day 1, 5 minutes after first cardioversion]
- Heart rate [Day 1, 7 minutes after first cardioversion]
- Heart rate [Day 1, 9 minutes after first cardioversion]
- Heart rate [Day 1, 10 minutes after first cardioversion]
- Heart rate [Day 1, 15 minutes after first cardioversion]
- Heart rate [Day 1, 20 minutes after first cardioversion]
- Heart rate [30 minutes after first cardioversion]
- Recall of pain at injection site - visual analog scale [Day 1]
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.
- Recall of anything unpleasant about the procedure - visual analog scale [Day 1]
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.
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Elijah Beaty, MD, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00061732