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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: propofol; Drug: sevoflurane

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• have paroxysmal atrial fibrillation
• undergoing their first ablation.

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: propofol; Participants receiving propofol as anesthetic for cardiac ablation.	Drug: propofol; Participant receives propofol as anesthetic for cardiac ablation.
Active Comparator: sevoflurane; Participants receiving sevoflurane as anesthetic for cardiac ablation.	Drug: sevoflurane; Participant receives sevoflurane as anesthetic for cardiac ablations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Duration	The duration of the procedure in minutes.	1 day
Time to Extubation	The time from procedure end to the time the patient is extubated, in minutes. A longer extubation time is a worse outcome.	Procedure end time to time of extubation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Operative Pain	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.	Post-Op Day 1
Number of Participants With Post-Operative Nausea and Vomiting	On Post-Op Day 1, patients were asked if they had experienced any nausea of vomiting since their procedure by answering "yes" or "no".	Time of procedure end to post-op day 1
Post-Operative Alertness	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.	Post-Op Day 1
Incidence of Atrial Fibrillation	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.	2 weeks post-op, 3 months post-op, and 6 months post-op.

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: George J Guldan, M.D., Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2016
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: February 29, 2016
• First Submitted That Met QC Criteria: February 29, 2016
• First Posted (Estimated): March 3, 2016

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: Pro00044072

Plan for Individual participant data (IPD)

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