Comparison of Propofol and Sevoflurane as a Primary Anesthetic for Cardiac Ablation of Atrial Fibrillation.
1 other identifier
interventional
135
1 country
1
Brief Summary
Comparison of propofol and sevoflurane as a primary anesthetic for cardiac ablation of atrial fibrillation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Jun 2016
Longer than P75 for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2016
CompletedFirst Posted
Study publicly available on registry
March 3, 2016
CompletedStudy Start
First participant enrolled
June 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedResults Posted
Study results publicly available
August 20, 2024
CompletedAugust 20, 2024
July 1, 2024
7.1 years
February 29, 2016
May 16, 2024
July 26, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Post-Operative Pain
Post-Op Day 1
Number of Participants With Post-Operative Nausea and Vomiting
Time of procedure end to post-op day 1
Post-Operative Alertness
Post-Op Day 1
- +1 more other outcomes
Study Arms (2)
propofol
ACTIVE COMPARATORParticipants receiving propofol as anesthetic for cardiac ablation.
sevoflurane
ACTIVE COMPARATORParticipants receiving sevoflurane as anesthetic for cardiac ablation.
Interventions
Eligibility Criteria
You may qualify if:
- have paroxysmal atrial fibrillation
- undergoing their first ablation.
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- George Guldan
- Organization
- Medical University of South Carolina
Study Officials
- PRINCIPAL INVESTIGATOR
George J Guldan, M.D.
Medical University of South Carolina
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 29, 2016
First Posted
March 3, 2016
Study Start
June 8, 2016
Primary Completion
June 30, 2023
Study Completion
February 28, 2024
Last Updated
August 20, 2024
Results First Posted
August 20, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share