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

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ClinicalTrials.gov Identifier: NCT02697448
Recruitment Status : Recruiting
First Posted : March 3, 2016
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
George Guldan, Medical University of South Carolina

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: propofol Drug: sevoflurane Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Propofol and Sevoflurane as a Primary Anesthetic for Cardiac Ablation of Atrial Fibrillation.
Study Start Date : February 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. procedure duration [ Time Frame: 1 day ]
    The duration of the procedure in minutes.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • have paroxysmal atrial fibrillation
  • undergoing their first ablation.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697448


Contacts
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Contact: Christie Aanstoos, MSN, RN 8437921869 aanstoos@musc.edu
Contact: Ross Glennda 843792-5699 rossg@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Principal Investigator: George J Guldan, M.D.         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: George J Guldan, M.D. Medical University of South Carolina

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Responsible Party: George Guldan, Principal Investigator, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02697448     History of Changes
Other Study ID Numbers: Pro00044072
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Propofol
Anesthetics
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation