Anesthetic Techniques and the Effect on Cardiac Electrophysiology Procedures
Overview
- Phase
- Phase 4
- Intervention
- Propofol
- Conditions
- Cardiac Disease
- Sponsor
- University of California, Los Angeles
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Effectiveness of Anesthetic Drugs in Terms of Patient Satisfaction.
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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)
Arms & Interventions
Sedation - Group 1
Sedation - monitored anesthesia with propofol.
Intervention: Propofol
Sedation - Group 2
Sedation - monitored anesthesia with ketamine + propofol
Intervention: Propofol
Sedation - Group 2
Sedation - monitored anesthesia with ketamine + propofol
Intervention: Ketamine
Sedation - Group 3
Sedation - monitored anesthesia with remifentanil + propofol
Intervention: Propofol
Sedation - Group 3
Sedation - monitored anesthesia with remifentanil + propofol
Intervention: Remifentanil
General Anesthesia - Group 1
General anesthesia (GA) with Sevoflurane + O2
Intervention: Sevoflurane
Outcomes
Primary Outcomes
Effectiveness of Anesthetic Drugs in Terms of Patient Satisfaction.
Time Frame: Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
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.
Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Adverse Events.
Time Frame: Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
Direct observation and medical record review will be used to analyze adverse effects. Reported as number of participants with one or more adverse events.
Effectiveness of Anesthetic Drugs in Terms of Pain Relief.
Time Frame: Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
A patient's pain level will be assessed using a numerical pain rating scale from 0 "no pain" to 10 "worst possible pain".
Effectiveness of Anesthetic Drugs in Terms of Patient Comfort.
Time Frame: Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
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.
Secondary Outcomes
- Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Clinical Success.(1-3 months postoperatively)
- Effectiveness of Anesthetic Drugs in Terms of Proceduralist Satisfaction.(Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.)