NCT02697448

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

Completed NA Results posted Last updated 20 August 2024

What this trial tests

NA trial testing propofol in Atrial Fibrillation in 135 participants. Completed in 28 February 2024.

Timeline

8 June 2016

Primary endpoint
30 June 2023

28 February 2024

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	135
Start date	8 June 2016
Primary completion	30 June 2023
Estimated completion	28 February 2024
Sites	1 location across United States

Drugs / interventions tested

• propofol (Propofol) — full drug profile →
• sevoflurane — full drug profile →

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Medical University of South Carolina

Who can join

Adults 18 to 80, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Procedure Duration Primary · 1 day

The duration of the procedure in minutes.

Group	Value	95% CI
Propofol	159.2	145.5 – 172.9
Sevoflurane	170.7	158.1 – 183.3

Time to Extubation Primary · 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.

Group	Value	95% CI
Propofol	11	6.0 – 15
Sevoflurane	8	4.0 – 12.0

Post-Operative Pain Secondary · 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.

Group	Value	95% CI
Propofol	2	1 – 4
Sevoflurane	2	1 – 4

Number of Participants With Post-Operative Nausea and Vomiting Secondary · 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".

Group	Value	95% CI
Propofol	4
Sevoflurane	4

Post-Operative Alertness Secondary · 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.

Group	Value	95% CI
Propofol	9	7 – 10
Sevoflurane	9	7 – 10

Incidence of Atrial Fibrillation Secondary · 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.

2 weeks post-op

Group	Value	95% CI
Propofol	13
Sevoflurane	12

3 months post-op

Group	Value	95% CI
Propofol	12
Sevoflurane	18

6 months post-op

Group	Value	95% CI
Propofol	10
Sevoflurane	17

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events related to the study intervention were collected from the time randomization occurred and the intervention was administered, and 24 hours post-operatively.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Propofol

Serious: 0/62 (0%)

Deaths: 0/62

Sevoflurane

Serious: 0/63 (0%)

Deaths: 0/63

Other adverse events (1 terms — click to expand)

Reaction	System	Propofol	Sevoflurane
Post-Operative Nausea and/or Vomiting	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT02697448 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.