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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Atrial Flutter
• Intervention / Treatment: Drug: Propofol; Drug: Methohexital

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:

1. 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.
2. 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: Interventional
• Enrollment (Actual): 73
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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)

Number of Arms

2

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.	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: Diprivan
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: Brevital; Brietal

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Elijah Beaty, MD, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2020
• Primary Completion (Actual): September 28, 2022
• Study Completion (Actual): September 28, 2022

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Propofol; Deep sedation; Cardioversion; Intravenous anesthetics
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol; Methohexital
• Other Study ID Numbers: IRB00061732

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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