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Comparison of propofol and sevoflurane as a primary anesthetic for cardiac ablation of atrial fibrillation
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propofol | Active Comparator | Participants receiving propofol as anesthetic for cardiac ablation. |
|
| sevoflurane | Active Comparator | Participants receiving sevoflurane as anesthetic for cardiac ablation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol | Drug | Participant receives propofol as anesthetic for cardiac ablation. |
| |
| 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 |
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| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George J Guldan, M.D. | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Propofol | Participants receiving propofol as anesthetic for cardiac ablation. propofol: Participant receives propofol as anesthetic for cardiac ablation. |
| FG001 | Sevoflurane | Participants receiving sevoflurane as anesthetic for cardiac ablation. sevoflurane: Participant receives sevoflurane as anesthetic for cardiac ablations. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol | Participants receiving propofol as anesthetic for cardiac ablation. propofol: Participant receives propofol as anesthetic for cardiac ablation. |
| BG001 | Sevoflurane |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Procedure Duration | The duration of the procedure in minutes. | Posted | Mean | 95% Confidence Interval | minutes | 1 day |
|
Adverse events related to the study intervention were collected from the time randomization occurred and the intervention was administered, and 24 hours post-operatively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Propofol | Participants receiving propofol as anesthetic for cardiac ablation. propofol: Participant receives propofol as anesthetic for cardiac ablation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-Operative Nausea and/or Vomiting | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George Guldan | Medical University of South Carolina | (843) 792-2322 | guldan@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 28, 2023 | Jun 13, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| sevoflurane |
| Drug |
Participant receives sevoflurane as anesthetic for cardiac ablations. |
|
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. |
| No data collected |
|
Participants receiving sevoflurane as anesthetic for cardiac ablation.
sevoflurane: Participant receives sevoflurane as anesthetic for cardiac ablations.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | Minutes | Procedure end time to time of extubation |
|
|
|
| Other Pre-specified | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Post-Op Day 1 |
|
|
|
| Other Pre-specified | 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". | Posted | Count of Participants | Participants | Time of procedure end to post-op day 1 |
|
|
|
| Other Pre-specified | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Post-Op Day 1 |
|
|
|
| Other Pre-specified | 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. | Posted | Count of Participants | Participants | 2 weeks post-op, 3 months post-op, and 6 months post-op. |
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| 4 |
| 62 |
| EG001 | Sevoflurane | Participants receiving sevoflurane as anesthetic for cardiac ablation. sevoflurane: Participant receives sevoflurane as anesthetic for cardiac ablations. | 0 | 63 | 0 | 63 | 4 | 63 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| 6 months post-op |
|