Direct observation and medical record review will be used to analyze adverse effects. Reported as number of participants with one or more adverse events.
Anesthetic Techniques in EP Patients
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.
Intervention / Treatment
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Propofol (DRUG)1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
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Ketamine (DRUG)1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
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Remifentanil (DRUG)1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
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Sevoflurane (DRUG)1 general anesthesia group for VT ablations and afib procedures.
Condition or Disease
- Cardiac Disease
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Terminated |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 35 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Other |
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Clinical Trial Dates
| Start date: | May 01, 2012 | ACTUAL |
|---|---|---|
| Primary Completion: | Sep 01, 2013 | ACTUAL |
| Completion Date: | Dec 01, 2013 | ACTUAL |
| Study First Posted: | Jan 27, 2016 | ESTIMATED |
| Results First Posted: | Sep 22, 2020 | ACTUAL |
| Last Updated: | Sep 21, 2020 |
Sponsors / Collaborators
Lead Sponsor:
University of California, Los Angeles
Lead sponsor is responsible party
Responsible Party:
N/A
Location
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.
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.
Participant Groups
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Sedation - monitored anesthesia with propofol.
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Sedation - monitored anesthesia with ketamine + propofol
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Sedation - monitored anesthesia with remifentanil + propofol
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General anesthesia (GA) with Sevoflurane + O2
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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)
* 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)
Primary Outcomes
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A patient's pain level will be assessed using a numerical pain rating scale from 0 "no pain" to 10 "worst possible pain".
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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.
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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.
Secondary Outcomes
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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.
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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.
More Details
| NCT Number: | NCT02664922 |
|---|---|
| Other IDs: | Anes Tech 11-003514 |
| Study URL: | https://clinicaltrials.gov/study/NCT02664922 |
Last updated: Sep 29, 2023