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

NCT04187196 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00061732
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Atrial Flutter

Keywords

Cardioversion; Propofol; Deep sedation; Intravenous anesthetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Time From End of Injection to Loss of Conscious

  Day 1

• Time to First Electrical Direct-current Shock

  Day 1

• Time to Eyes Opening

  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

Study Arms (2)

Sedation with propofol group

EXPERIMENTAL

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

Drug: Propofol

Sedation with methohexital group

EXPERIMENTAL

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

Drug: Methohexital

Interventions

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

Also known as: Diprivan

Sedation with propofol group

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

Also known as: Brevital, Brietal

Sedation with methohexital group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• 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.

  PMID: 36129031 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Interventions

Propofol; Methohexital

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Elijah Beaty, MD, MPH, FACC
• Organization: Atrium Health

Elijah.Beaty@atriumhealth.org

704-403-6100

Study Officials

• Elijah Beaty, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 5, 2019
• Study Start: April 29, 2020
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)