Anesthetic Techniques in EP Patients

Study Overview
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Brief Summary
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The purpose of this study is to compare different combinations of anesthetic drugs (cause loss of sensation) in terms of effectiveness, adverse effects, pain relief, and patient comfort for cardiac electrophysiology procedures. In addition, the investigators are studying the different anesthetic combinations to determine the best approach in terms of identification and treatment of arrhythmias.

Detailed Description
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Anesthetic management in patients coming for electrophysiology procedures is extremely important and hemodynamically challenging in order to minimize interference on the electrophysiology studies (EPS) and the ability to trigger arrhythmias while also maintaining patient comfort and limited movement. Various anesthetic combinations are administered to provide sedation, analgesia/sedation, or general anesthesia. The ideal agent should produce rapid loss of consciousness while ensuring cardiovascular stability and prompt recovery with few adverse effects. Our goal is to study anesthetic techniques and the effect on electrophysiology procedures to determine the best anesthetic combination in terms of effectiveness, adverse effects, pain relief, and patient comfort. Adult patients scheduled for electrophysiology procedures will be enrolled in the study and randomly assigned to an anesthetic group based on their schedule procedure. Sedation cases for supraventricular tachycardia (SVT), right ventricular outflow tract (RVOT)/premature ventricular contraction (PVC) ablation, and atrial flutter (aflutter) procedures will be randomly assigned to one of three groups: 1) monitored anesthesia (local anesthesia with sedation and analgesia/pain reliever) with propofol (induce sleep), 2) monitored anesthesia with ketamine (sedation) + propofol (induce sleep), or 3) monitored anesthesia with remifentanil infusion (pain reliever) + propofol (induce sleep). Sedation cases for ventricular tachycardia (VT) ablation and atrial fibrillation (afib) procedures will be randomly assigned to one of two groups: 1) monitored anesthesia (local anesthesia with sedation and analgesia/pain reliever) with propofol (induce sleep), or 2) monitored anesthesia with ketamine (sedation) + propofol (induce sleep). General anesthesia (GA) cases, including VT ablation and afib procedures will receive general anesthesia (state of unconsciousness) with sevoflurane (loss of consciousness) + O2. Anesthesia factors, such as hemodynamics and cerebral oxygen saturation will be continuously monitored and recorded throughout the study. In addition, we will be looking at standard echocardiogram and electrophysiology (EP) parameters. The patient's pain level, level of sedation, and satisfaction will also be measured using scales, assessments, and surveys.

Official Title
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Anesthetic Techniques and the Effect on Cardiac Electrophysiology Procedures

Conditions
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Cardiac Disease

Intervention / Treatment
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* Drug: Propofol
* Drug: Ketamine
* Drug: Remifentanil
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for cardiac electrophysiology procedures Patients ≥18 years of age Exclusion Criteria: Gastroesophageal reflux disease (GERD), pulmonary hypertension, severe pulmonary disease, obstructive sleep apnea (OSA) with continuous positive airway pressure therapy (CPAP)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sedation - Group 1<br>Sedation - monitored anesthesia with propofol. | Drug: Propofol<br>* 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.<br>* Other names: Diprivan;|
| Experimental: Sedation - Group 2<br>Sedation - monitored anesthesia with ketamine + propofol | Drug: Propofol<br>* 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.<br>* Other names: Diprivan;Drug: Ketamine<br>* 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.<br>* Other names: Ketalar;|
| Experimental: Sedation - Group 3<br>Sedation - monitored anesthesia with remifentanil + propofol | Drug: Propofol<br>* 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.<br>* Other names: Diprivan;Drug: Remifentanil<br>* 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.<br>* Other names: Ultiva;|
| Experimental: General Anesthesia - Group 1<br>General anesthesia (GA) with Sevoflurane + O2 | Drug: Sevoflurane<br>* 1 general anesthesia group for VT ablations and afib procedures.<br>* Other names: Ultane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Adverse Events. | Direct observation and medical record review will be used to analyze adverse effects. Reported as number of participants with one or more adverse events. | Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours. | 
| Effectiveness of Anesthetic Drugs in Terms of Pain Relief. | A patient's pain level will be assessed using a numerical pain rating scale from 0 no pain to 10 worst possible pain. | Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours. | 
| Effectiveness of Anesthetic Drugs in Terms of Patient Comfort. | A patient's level of sedation will be assessed using a scoring system on a scale from 1-5. The Observer's Assessment of Alertness/Sedation (OAA/S) Score Responsiveness Component score from 1 - Does not respond to mild prodding or shaking to 5 - Responds readily to name spoken in normal tone. | Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours. | 
| Effectiveness of Anesthetic Drugs in Terms of Patient Satisfaction. | Patients will also be asked to complete a written questionnaire prior to discharge from the hospital to measure patient satisfaction during their anesthesia care. A Likert Scale is used and ranges from 1 - Disagree very much to 6 - Agree very much. | Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of Anesthetic Drugs in Terms of Proceduralist Satisfaction. | The proceduralist will complete a written questionnaire after the procedure to rate their satisfaction. A Likert Scale is used and ranges from 1 - Disagree very much to 6 - Agree very much. | Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours. | 
| Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Clinical Success. | The proceduralist will follow-up 1-3 months post-procedure to evaluate the number of participants with clinical success reported by number of recurrences. Clinical success is defined as 0 recurrences in participants at 1-3 months post-operatively. | 1-3 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrophysiology, Anesthetics