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

Primary Purpose

Atrial Fibrillation, Atrial Flutter

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Propofol
Methohexital
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Cardioversion, Propofol, Deep sedation, Intravenous anesthetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Wake Forest Baptist Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sedation with propofol group

Sedation with methohexital group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time from initiation of sedation to full recovery
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
Recorded in seconds.
Time to first shock
Recorded in seconds.
Time to eyes opening
Recorded in seconds.
Systolic Blood Pressure
Systolic Blood Pressure
Systolic Blood Pressure
Systolic Blood Pressure
Systolic Blood Pressure
Systolic Blood Pressure
Systolic Blood Pressure
Systolic Blood Pressure
Systolic Blood Pressure
Systolic Blood Pressure
Systolic Blood Pressure
Diastolic Blood Pressure
Diastolic Blood Pressure
Diastolic Blood Pressure
Diastolic Blood Pressure
Diastolic Blood Pressure
Diastolic Blood Pressure
Diastolic Blood Pressure
Diastolic Blood Pressure
Diastolic Blood Pressure
Diastolic Blood Pressure
Diastolic Blood Pressure
Mean arterial Blood Pressure
Mean arterial Blood Pressure
Mean arterial Blood Pressure
Mean arterial Blood Pressure
Mean arterial Blood Pressure
Mean arterial Blood Pressure
Mean arterial Blood Pressure
Mean arterial Blood Pressure
Mean arterial Blood Pressure
Mean arterial Blood Pressure
Mean arterial Blood Pressure
Respiratory Rate
Respiratory Rate
Respiratory Rate
Respiratory Rate
Respiratory Rate
Respiratory Rate
Respiratory Rate
Respiratory Rate
Respiratory Rate
Respiratory Rate
SpO2
SpO2
SpO2
SpO2
SpO2
SpO2
SpO2
SpO2
SpO2
SpO2
SpO2
Heart rate
Heart rate
Heart rate
Heart rate
Heart rate
Heart rate
Heart rate
Heart rate
Heart rate
Heart rate
Heart rate
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.
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.

Full Information

First Posted
November 26, 2019
Last Updated
December 4, 2022
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04187196
Brief Title
Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion
Official Title
Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 29, 2020 (Actual)
Primary Completion Date
September 28, 2022 (Actual)
Study Completion Date
September 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Flutter
Keywords
Cardioversion, Propofol, Deep sedation, Intravenous anesthetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sedation with propofol group
Arm Type
Experimental
Arm Description
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
Arm Title
Sedation with methohexital group
Arm Type
Experimental
Arm Description
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Methohexital
Other Intervention Name(s)
Brevital, Brietal
Intervention Description
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
Primary Outcome Measure Information:
Title
Time from initiation of sedation to full recovery
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Time from end of injection to loss of conscious
Description
Recorded in seconds.
Time Frame
Day 1
Title
Time to first shock
Description
Recorded in seconds.
Time Frame
Day 1
Title
Time to eyes opening
Description
Recorded in seconds.
Time Frame
Day 1
Title
Systolic Blood Pressure
Time Frame
Day 1, at induction
Title
Systolic Blood Pressure
Time Frame
Day 1, prior to first shock
Title
Systolic Blood Pressure
Time Frame
Day 1,1 minute after first cardioversion
Title
Systolic Blood Pressure
Time Frame
Day 1,3 minutes after first cardioversion
Title
Systolic Blood Pressure
Time Frame
Day 1,5 minutes after first cardioversion
Title
Systolic Blood Pressure
Time Frame
Day 1,7 minutes after first cardioversion
Title
Systolic Blood Pressure
Time Frame
Day 1,9 minutes after first cardioversion
Title
Systolic Blood Pressure
Time Frame
Day 1,10 minutes after first cardioversion
Title
Systolic Blood Pressure
Time Frame
Day 1,15 minutes after first cardioversion
Title
Systolic Blood Pressure
Time Frame
Day 1,20 minutes after first cardioversion
Title
Systolic Blood Pressure
Time Frame
Day 1,30 minutes after first cardioversion
Title
Diastolic Blood Pressure
Time Frame
Day 1, at induction
Title
Diastolic Blood Pressure
Time Frame
Day 1, prior to first shock
Title
Diastolic Blood Pressure
Time Frame
Day 1,1 minute after first cardioversion
Title
Diastolic Blood Pressure
Time Frame
Day 1,3 minutes after first cardioversion
Title
Diastolic Blood Pressure
Time Frame
Day 1,5 minutes after first cardioversion
Title
Diastolic Blood Pressure
Time Frame
Day 1,7 minutes after first cardioversion
Title
Diastolic Blood Pressure
Time Frame
Day 1,9 minutes after first cardioversion
Title
Diastolic Blood Pressure
Time Frame
Day 1,10 minutes after first cardioversion
Title
Diastolic Blood Pressure
Time Frame
Day 1,15 minutes after first cardioversion
Title
Diastolic Blood Pressure
Time Frame
Day 1, 20 minutes after first cardioversion
Title
Diastolic Blood Pressure
Time Frame
Day 1, 30 minutes after first cardioversion
Title
Mean arterial Blood Pressure
Time Frame
Day 1, at induction
Title
Mean arterial Blood Pressure
Time Frame
Day 1, prior to fist shock
Title
Mean arterial Blood Pressure
Time Frame
Day 1, 1 minute after first cardioversion
Title
Mean arterial Blood Pressure
Time Frame
Day 1, 3 minutes after first cardioversion
Title
Mean arterial Blood Pressure
Time Frame
Day 1, 5 minutes after first cardioversion
Title
Mean arterial Blood Pressure
Time Frame
Day 1, 7 minutes after first cardioversion
Title
Mean arterial Blood Pressure
Time Frame
Day 1, 9 minutes after first cardioversion
Title
Mean arterial Blood Pressure
Time Frame
Day 1, 10 minutes after first cardioversion
Title
Mean arterial Blood Pressure
Time Frame
Day 1, 15 minutes after first cardioversion
Title
Mean arterial Blood Pressure
Time Frame
Day 1, 20 minutes after first cardioversion
Title
Mean arterial Blood Pressure
Time Frame
Day 1, 30 minutes after first cardioversion
Title
Respiratory Rate
Time Frame
Day 1, prior to first shock
Title
Respiratory Rate
Time Frame
Day 1,1 minute after first cardioversion
Title
Respiratory Rate
Time Frame
Day 1, 3 minutes after first cardioversion
Title
Respiratory Rate
Time Frame
Day 1, 5 minutes after first cardioversion
Title
Respiratory Rate
Time Frame
Day 1, 7 minutes after first cardioversion
Title
Respiratory Rate
Time Frame
Day 1, 9 minutes after first cardioversion
Title
Respiratory Rate
Time Frame
Day 1, 10 minutes after first cardioversion
Title
Respiratory Rate
Time Frame
Day 1, 15 minutes after first cardioversion
Title
Respiratory Rate
Time Frame
Day 1, 20 minutes after first cardioversion
Title
Respiratory Rate
Time Frame
Day 1, 30 minutes after first cardioversion
Title
SpO2
Time Frame
Day 1, at induction
Title
SpO2
Time Frame
Day 1, prior to first shock
Title
SpO2
Time Frame
Day 1, 1 minute after first cardioversion
Title
SpO2
Time Frame
Day 1, 3 minutes after first cardioversion
Title
SpO2
Time Frame
Day 1, 5 minutes after first cardioversion
Title
SpO2
Time Frame
Day 1, 7 minutes after first cardioversion
Title
SpO2
Time Frame
Day 1, 9 minutes after first cardioversion
Title
SpO2
Time Frame
Day 1, 10 minutes after first cardioversion
Title
SpO2
Time Frame
Day 1, 15 minutes after first cardioversion
Title
SpO2
Time Frame
Day 1, 20 minutes after first cardioversion
Title
SpO2
Time Frame
Day 1, 30 minutes after first cardioversion
Title
Heart rate
Time Frame
Day 1, at induction
Title
Heart rate
Time Frame
Day 1, prior to first shock
Title
Heart rate
Time Frame
Day 1,1 minute after first cardioversion
Title
Heart rate
Time Frame
Day 1, 3 minutes after first cardioversion
Title
Heart rate
Time Frame
Day 1, 5 minutes after first cardioversion
Title
Heart rate
Time Frame
Day 1, 7 minutes after first cardioversion
Title
Heart rate
Time Frame
Day 1, 9 minutes after first cardioversion
Title
Heart rate
Time Frame
Day 1, 10 minutes after first cardioversion
Title
Heart rate
Time Frame
Day 1, 15 minutes after first cardioversion
Title
Heart rate
Time Frame
Day 1, 20 minutes after first cardioversion
Title
Heart rate
Time Frame
30 minutes after first cardioversion
Title
Recall of pain at injection site - visual analog scale
Description
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
Title
Recall of anything unpleasant about the procedure - visual analog scale
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elijah Beaty, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36129031
Citation
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.
Results Reference
derived

Learn more about this trial

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

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