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

Primary Purpose

Atrial Fibrillation

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

propofol

sevoflurane

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

have paroxysmal atrial fibrillation
undergoing their first ablation.

Exclusion Criteria:

none

Sites / Locations

Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

propofol

sevoflurane

Arm Description

Participants receiving propofol as anesthetic for cardiac ablation.

Participants receiving sevoflurane as anesthetic for cardiac ablation.

Outcomes

Primary Outcome Measures

procedure duration

The duration of the procedure in minutes.

Secondary Outcome Measures

Full Information

NCT ID

NCT02697448

First Posted

February 29, 2016

Last Updated

June 2, 2023

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT02697448

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 8, 2016 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of South Carolina

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

propofol

Arm Type

Active Comparator

Arm Description

Participants receiving propofol as anesthetic for cardiac ablation.

Arm Title

sevoflurane

Arm Type

Active Comparator

Arm Description

Participants receiving sevoflurane as anesthetic for cardiac ablation.

Intervention Type

Drug

Intervention Name(s)

propofol

Intervention Description

Participant receives propofol as anesthetic for cardiac ablation.

Intervention Type

Drug

Intervention Name(s)

sevoflurane

Intervention Description

Participant receives sevoflurane as anesthetic for cardiac ablations.

Primary Outcome Measure Information:

Title

procedure duration

Description

The duration of the procedure in minutes.

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: have paroxysmal atrial fibrillation undergoing their first ablation. Exclusion Criteria: none

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Haley Nitchie

Phone

8437921869

nitchie@musc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Ross Glennda

Phone

843792-5699

rossg@musc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George J Guldan, M.D.

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

George J Guldan, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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