Mode
Text Size
Log in / Sign up
N/A N=100 Randomized Double-blind Health Services Research

General Anesthesia With ETT vs LMA in Patients Undergoing Ablation for Atrial Fibrillation

Atrial Fibrillation

Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Procedure Time (Minutes) — 128.7; 137.8 minutes

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
General Anesthesia with endotracheal tube (Device); General Anesthesia with laryngeal mask airway (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Virginia Commonwealth University
Primary completion
Dec 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Procedure Time (Minutes)
128.7; 137.8
SECONDARY
Fluoroscopy Time
27.1; 28.7
SECONDARY
Total Anesthesia Time
179; 184.7
SECONDARY
Time to Discharge From PACU
SECONDARY
Total Intra-procedure Opioids
111.7; 109.2
SECONDARY
Anesthetic Requirements
SECONDARY
Anesthetic Requirements
SECONDARY
Intraoperative Hemodynamics
SECONDARY
Intraoperative Hemodynamics
SECONDARY
Intraoperative Hemodynamics
SECONDARY
Intraoperative Hemodynamics
SECONDARY
Intraprocedure Pressor/Ionotrope/Chronotrope Requirements
8.8; 5.4; 0.2; 5.5
SECONDARY
Electrophysiology Parameters
SECONDARY
Electrophysiology Parameters
SECONDARY
Electrophysiology Parameters
SECONDARY
Airway Trauma
0; 0
SECONDARY
Post-procedure Nausea
0.3; 0.9
SECONDARY
Post-procedure Emesis
SECONDARY
Atrial Fibrillation Recurrence
2; 2
SECONDARY
Aspiration Events
0; 0
SECONDARY
Patient Satisfaction
34; 36; 9; 6; 0; 2
SECONDARY
Cost Analysis

Summary

In recent years it has been shown that catheter ablation of symptomatic atrial fibrillation (PAF) is superior to antiarrhythmic drug therapy with regards to effectiveness and clinical outcomes. Atrial fibrillation is the most common cardiac arrhythmia, with high rates of concomitant heart failure, stroke and mortality. During an ablation procedure, a patient can be managed with intravenous sedation or General Anesthesia (GA). Within this setting, General anesthesia is associated with improved procedure time and cure rate compared to sedation. Airway management during GA can be achieved through a laryngeal mask airway (LMA) or an endotracheal tube (ETT). The use of LMA compared to ETT has been shown in different surgical populations to decrease procedure and recovery time, improve hemodynamic stability and reduce anesthetic requirements. It has also shown to decrease airway complications, and postoperative nausea/vomiting which are important factors that affect overall patient satisfaction. Although general anesthesia in electrophysiology procedures is associated with a higher cure rate, there have been reports of increased airway trauma.Additionally, it is believed that volatile anesthetics may be associated with increased ventricular action potential duration as well as prolonged QT interval. The increased usage of opioids during general anesthesia is also thought to interfere with electrophysiology studies by affecting vagal tone. At Virginia Commonwealth University (VCU) Health system, Anesthesiologists have been successfully using LMA (General Anesthesia) for ablation in PAF in eligible patients for over five years. The investigators plan to perform a retrospective review of all patients who underwent catheter ablation of PAF at Virginia Commonwealth University Health System from January 2014 - December 2015. The primary endpoint evaluated will be procedure time. Other data collected will include demographics, cardiac history, type of anesthesia, amount of intra-procedure opioids, time to discharge from post anesthesia care unit (PACU), total length of hospital stay, intra-procedure hemodynamics, intra-procedure ionotrope/chronotrope/pressor requirements. and atrial fibrillation recurrence at a 3 month follow-up.

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing primary ablation for paroxysmal atrial fibrillation
  • Able to obtain consent in English language
  • BMI 35
  • Pregnancy
  • Prisoners
  • Patients unable to give their own consent
  • Patients having trans esophageal echo on the same day
  • Patients unable to give consent in English language
  • Patients will also be excluded if the attending anesthesiologist determines that they would not be suitable candidates for intubation with either method (ETT tube or LMA mask).
  • Patients with severe gastroesophageal reflux disease
  • Patients with high risk of aspiration
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02896595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search