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Completed

NCT Number: NCT04187196

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Flutter Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Propofol

Drug

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

Methohexital

Drug

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

Primary outcomes

  1. Time From Initiation of Sedation to Full Recovery

    Time frame: Day 1

    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.

Secondary outcomes

  1. Time From End of Injection to Loss of Conscious

    Time frame: Day 1

    Recorded in minutes.

  2. Time to First Electrical Direct-current Shock

    Time frame: Day 1

    Recorded in seconds.

  3. Time to Eyes Opening

    Time frame: Day 1

    Recorded in seconds.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Recall of Pain at Injection Site - Visual Analog Scale

    Time frame: 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.

  11. Recall of Anything Unpleasant About the Procedure - Visual Analog Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 5, 2019
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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