- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04187196
Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion
Study Overview
Status
Conditions
Intervention / Treatment
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:
1. There will be no significant increase in adverse events associated with the use of methohexital when compared with propofol.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sedation with propofol group
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
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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:
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Experimental: Sedation with methohexital group
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time From Initiation of Sedation to Full Recovery
Time Frame: Day 1
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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.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time From End of Injection to Loss of Conscious
Time Frame: Day 1
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Recorded in minutes.
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Day 1
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Time to First Electrical Direct-current Shock
Time Frame: Day 1
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Recorded in seconds.
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Day 1
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Time to Eyes Opening
Time Frame: Day 1
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Recorded in seconds.
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Day 1
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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
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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
|
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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Recall of Pain at Injection Site - Visual Analog Scale
Time Frame: Day 1
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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.
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Day 1
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Recall of Anything Unpleasant About the Procedure - Visual Analog Scale
Time Frame: Day 1
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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.
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Day 1
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Collaborators and Investigators
Investigators
- Principal Investigator: Elijah Beaty, MD, Wake Forest University Health Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00061732
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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