Trial Outcomes & Findings for Comparison of Propofol and Sevoflurane as a Primary Anesthetic for Cardiac Ablation of Atrial Fibrillation. (NCT NCT02697448)
NCT ID: NCT02697448
Last Updated: 2024-08-20
Results Overview
The duration of the procedure in minutes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
135 participants
Primary outcome timeframe
1 day
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
Propofol
Participants receiving propofol as anesthetic for cardiac ablation.
propofol: Participant receives propofol as anesthetic for cardiac ablation.
|
Sevoflurane
Participants receiving sevoflurane as anesthetic for cardiac ablation.
sevoflurane: Participant receives sevoflurane as anesthetic for cardiac ablations.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
68
|
|
Overall Study
COMPLETED
|
62
|
63
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Propofol
Participants receiving propofol as anesthetic for cardiac ablation.
propofol: Participant receives propofol as anesthetic for cardiac ablation.
|
Sevoflurane
Participants receiving sevoflurane as anesthetic for cardiac ablation.
sevoflurane: Participant receives sevoflurane as anesthetic for cardiac ablations.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
4
|
|
Overall Study
Clinical concerns during ablation
|
1
|
1
|
|
Overall Study
No data collected
|
2
|
0
|
Baseline Characteristics
Comparison of Propofol and Sevoflurane as a Primary Anesthetic for Cardiac Ablation of Atrial Fibrillation.
Baseline characteristics by cohort
| Measure |
Propofol
n=62 Participants
Participants receiving propofol as anesthetic for cardiac ablation.
propofol: Participant receives propofol as anesthetic for cardiac ablation.
|
Sevoflurane
n=63 Participants
Participants receiving sevoflurane as anesthetic for cardiac ablation.
sevoflurane: Participant receives sevoflurane as anesthetic for cardiac ablations.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 8.63 • n=99 Participants
|
64.3 years
STANDARD_DEVIATION 11.3 • n=107 Participants
|
66.0 years
STANDARD_DEVIATION 10.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
55 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black, or Other
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
BMI
|
30.4 kg/m^2
STANDARD_DEVIATION 5.81 • n=99 Participants
|
30.8 kg/m^2
STANDARD_DEVIATION 7.08 • n=107 Participants
|
30.6 kg/m^2
STANDARD_DEVIATION 6.42 • n=206 Participants
|
PRIMARY outcome
Timeframe: 1 dayThe duration of the procedure in minutes.
Outcome measures
| Measure |
Propofol
n=62 Participants
Participants receiving propofol as anesthetic for cardiac ablation.
propofol: Participant receives propofol as anesthetic for cardiac ablation.
|
Sevoflurane
n=63 Participants
Participants receiving sevoflurane as anesthetic for cardiac ablation.
sevoflurane: Participant receives sevoflurane as anesthetic for cardiac ablations.
|
|---|---|---|
|
Procedure Duration
|
159.2 minutes
Interval 145.5 to 172.9
|
170.7 minutes
Interval 158.1 to 183.3
|
PRIMARY outcome
Timeframe: Procedure end time to time of extubationThe time from procedure end to the time the patient is extubated, in minutes. A longer extubation time is a worse outcome.
Outcome measures
| Measure |
Propofol
n=62 Participants
Participants receiving propofol as anesthetic for cardiac ablation.
propofol: Participant receives propofol as anesthetic for cardiac ablation.
|
Sevoflurane
n=63 Participants
Participants receiving sevoflurane as anesthetic for cardiac ablation.
sevoflurane: Participant receives sevoflurane as anesthetic for cardiac ablations.
|
|---|---|---|
|
Time to Extubation
|
11 Minutes
Interval 6.0 to 15.0
|
8 Minutes
Interval 4.0 to 12.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-Op Day 1Post-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.
Outcome measures
| Measure |
Propofol
n=62 Participants
Participants receiving propofol as anesthetic for cardiac ablation.
propofol: Participant receives propofol as anesthetic for cardiac ablation.
|
Sevoflurane
n=63 Participants
Participants receiving sevoflurane as anesthetic for cardiac ablation.
sevoflurane: Participant receives sevoflurane as anesthetic for cardiac ablations.
|
|---|---|---|
|
Post-Operative Pain
|
2 units on a scale
Interval 1.0 to 4.0
|
2 units on a scale
Interval 1.0 to 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time of procedure end to post-op day 1On Post-Op Day 1, patients were asked if they had experienced any nausea of vomiting since their procedure by answering "yes" or "no".
Outcome measures
| Measure |
Propofol
n=62 Participants
Participants receiving propofol as anesthetic for cardiac ablation.
propofol: Participant receives propofol as anesthetic for cardiac ablation.
|
Sevoflurane
n=63 Participants
Participants receiving sevoflurane as anesthetic for cardiac ablation.
sevoflurane: Participant receives sevoflurane as anesthetic for cardiac ablations.
|
|---|---|---|
|
Number of Participants With Post-Operative Nausea and Vomiting
|
4 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-Op Day 1Patients 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.
Outcome measures
| Measure |
Propofol
n=62 Participants
Participants receiving propofol as anesthetic for cardiac ablation.
propofol: Participant receives propofol as anesthetic for cardiac ablation.
|
Sevoflurane
n=63 Participants
Participants receiving sevoflurane as anesthetic for cardiac ablation.
sevoflurane: Participant receives sevoflurane as anesthetic for cardiac ablations.
|
|---|---|---|
|
Post-Operative Alertness
|
9 units on a scale
Interval 7.0 to 10.0
|
9 units on a scale
Interval 7.0 to 10.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Propofol
n=62 Participants
Participants receiving propofol as anesthetic for cardiac ablation.
propofol: Participant receives propofol as anesthetic for cardiac ablation.
|
Sevoflurane
n=63 Participants
Participants receiving sevoflurane as anesthetic for cardiac ablation.
sevoflurane: Participant receives sevoflurane as anesthetic for cardiac ablations.
|
|---|---|---|
|
Incidence of Atrial Fibrillation
2 weeks post-op
|
13 Participants
|
12 Participants
|
|
Incidence of Atrial Fibrillation
3 months post-op
|
12 Participants
|
18 Participants
|
|
Incidence of Atrial Fibrillation
6 months post-op
|
10 Participants
|
17 Participants
|
Adverse Events
Propofol
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Sevoflurane
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Propofol
n=62 participants at risk
Participants receiving propofol as anesthetic for cardiac ablation.
propofol: Participant receives propofol as anesthetic for cardiac ablation.
|
Sevoflurane
n=63 participants at risk
Participants receiving sevoflurane as anesthetic for cardiac ablation.
sevoflurane: Participant receives sevoflurane as anesthetic for cardiac ablations.
|
|---|---|---|
|
Nervous system disorders
Post-Operative Nausea and/or Vomiting
|
6.5%
4/62 • Number of events 4 • Adverse events related to the study intervention were collected from the time randomization occurred and the intervention was administered, and 24 hours post-operatively.
|
6.3%
4/63 • Number of events 4 • Adverse events related to the study intervention were collected from the time randomization occurred and the intervention was administered, and 24 hours post-operatively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place