Atrial Fibrillation
Conditions
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.
Interventions
DRUGpropofol
Participant receives propofol as anesthetic for cardiac ablation.
DRUGsevoflurane
Participant receives sevoflurane as anesthetic for cardiac ablations.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* have paroxysmal atrial fibrillation * undergoing their first ablation.
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Duration | 1 day | The duration of the procedure in minutes. |
| Time to Extubation | Procedure end time to time of extubation | The time from procedure end to the time the patient is extubated, in minutes. A longer extubation time is a worse outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post-Operative Pain | Post-Op Day 1 | 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. |
| Number of Participants With Post-Operative Nausea and Vomiting | Time of procedure end to post-op day 1 | On Post-Op Day 1, patients were asked if they had experienced any nausea of vomiting since their procedure by answering yes or no. |
| Post-Operative Alertness | Post-Op Day 1 | 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. |
| Incidence of Atrial Fibrillation | 2 weeks post-op, 3 months post-op, and 6 months post-op. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Propofol Participants receiving propofol as anesthetic for cardiac ablation.
propofol: Participant receives propofol as anesthetic for cardiac ablation. | 62 |
| Sevoflurane Participants receiving sevoflurane as anesthetic for cardiac ablation.
sevoflurane: Participant receives sevoflurane as anesthetic for cardiac ablations. | 63 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Clinical concerns during ablation | 1 | 1 |
| Overall Study | No data collected | 2 | 0 |
| Overall Study | Protocol Violation | 2 | 4 |
Baseline characteristics
| Characteristic | Propofol | Sevoflurane | Total |
|---|---|---|---|
| Age, Continuous | 67.6 years STANDARD_DEVIATION 8.63 | 64.3 years STANDARD_DEVIATION 11.3 | 66.0 years STANDARD_DEVIATION 10.2 |
| BMI | 30.4 kg/m^2 STANDARD_DEVIATION 5.81 | 30.8 kg/m^2 STANDARD_DEVIATION 7.08 | 30.6 kg/m^2 STANDARD_DEVIATION 6.42 |
| Race/Ethnicity, Customized Black, or Other | 7 Participants | 5 Participants | 12 Participants |
| Race/Ethnicity, Customized White | 55 Participants | 58 Participants | 113 Participants |
| Sex: Female, Male Female | 16 Participants | 14 Participants | 30 Participants |
| Sex: Female, Male Male | 46 Participants | 49 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 63 |
| other Total, other adverse events | 4 / 62 | 4 / 63 |
| serious Total, serious adverse events | 0 / 62 | 0 / 63 |
Outcome results
Primary
Procedure Duration
The duration of the procedure in minutes.
Time frame: 1 day
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Propofol | Procedure Duration | 159.2 minutes |
| Sevoflurane | Procedure Duration | 170.7 minutes |
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.
Time frame: Procedure end time to time of extubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Propofol | Time to Extubation | 11 Minutes |
| Sevoflurane | Time to Extubation | 8 Minutes |
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.
Time frame: 2 weeks post-op, 3 months post-op, and 6 months post-op.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Propofol | Incidence of Atrial Fibrillation | 2 weeks post-op | 13 Participants |
| Propofol | Incidence of Atrial Fibrillation | 3 months post-op | 12 Participants |
| Propofol | Incidence of Atrial Fibrillation | 6 months post-op | 10 Participants |
| Sevoflurane | Incidence of Atrial Fibrillation | 2 weeks post-op | 12 Participants |
| Sevoflurane | Incidence of Atrial Fibrillation | 3 months post-op | 18 Participants |
| Sevoflurane | Incidence of Atrial Fibrillation | 6 months post-op | 17 Participants |
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.
Time frame: Time of procedure end to post-op day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Propofol | Number of Participants With Post-Operative Nausea and Vomiting | 4 Participants |
| Sevoflurane | Number of Participants With Post-Operative Nausea and Vomiting | 4 Participants |
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.
Time frame: Post-Op Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Propofol | Post-Operative Alertness | 9 units on a scale |
| Sevoflurane | Post-Operative Alertness | 9 units on a scale |
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.
Time frame: Post-Op Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Propofol | Post-Operative Pain | 2 units on a scale |
| Sevoflurane | Post-Operative Pain | 2 units on a scale |