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Completed

NCT Number: NCT02697448

Comparison of Propofol and Sevoflurane as a Primary Anesthetic for Cardiac Ablation of Atrial Fibrillation.

Comparison of propofol and sevoflurane as a primary anesthetic for cardiac ablation of atrial fibrillation

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

A side effect of some volatile anesthetics, such as isoflurane and desflurane, is enhanced automaticity, accounting for secondary atrial pacemakers. Volatile anesthetics also have varying effects on the AV node and His-Pukinje system. These agents also prolong the QT interval and, for this reason, volatile anesthetics as a group have at times been avoided for atrial fibrillation ablation due to the fear that they may affect the efficacy of the ablation and increase recurrence. However, sevoflurane does not have the effects shown for other volatile anesthetics cardiac conduction. At this point there has not been a study comparing propofol, a non volatile anesthetic typically used in these cases, to sevoflurane, a volatile anesthetic, to determine if volatile anesthetics should be avoided during these procedures. This study will challenge the existing belief that sevoflurane increases the length of time to ablate atrial fibrillation and also decreases the efficacy of the ablation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • have paroxysmal atrial fibrillation
  • undergoing their first ablation.

Exclusion criteria

  • none

Treatment and study plan

Propofol

Drug

Participant receives propofol as anesthetic for cardiac ablation.

Sevoflurane

Drug

Participant receives sevoflurane as anesthetic for cardiac ablations.

Primary outcomes

  1. Procedure Duration

    Time frame: 1 day

    The duration of the procedure in minutes.

  2. Time to Extubation

    Time frame: Procedure end time to time of extubation

    The time from procedure end to the time the patient is extubated, in minutes. A longer extubation time is a worse outcome.

Other outcomes

  1. Post-Operative Pain

    Time frame: Post-Op Day 1

    Post-Operative Pain was measured on a Numeric Rating Scale of 0-10, and assessed on Post-Op Day 1 by asking the patient to rate their pain while resting. Zero meant no pain, and 10 meant worst pain imaginable. A higher number is a worse outcome.

  2. Number of Participants With Post-Operative Nausea and Vomiting

    Time frame: Time of procedure end to post-op day 1

    On Post-Op Day 1, patients were asked if they had experienced any nausea of vomiting since their procedure by answering "yes" or "no".

  3. Post-Operative Alertness

    Time frame: Post-Op Day 1

    Patients were asked on Post-Op Day 1 to rate how alert they felt on a numeric rating scale from 0-10. Zero meant very groggy, and 10 meant back to normal alertness. The higher the number, the better the outcome.

  4. Incidence of Atrial Fibrillation

    Time frame: 2 weeks post-op, 3 months post-op, and 6 months post-op.

    This outcome examines the association between treatment group and postoperative time with recurrence of atrial fibrillation in the first 6 months following the procedure. The numbers reported reflect whether or not the participant experienced an atrial fibrillation in the specified time period.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Important dates

Study start
2016
Primary completion
2023
Study completion
2024
First posted
Mar 3, 2016
Registry last updated
Aug 20, 2024

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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