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Poor study design and too many study groups.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sedation - Group 1 | Experimental | Sedation - monitored anesthesia with propofol. |
|
| Sedation - Group 2 | Experimental | Sedation - monitored anesthesia with ketamine + propofol |
|
| Sedation - Group 3 | Experimental | Sedation - monitored anesthesia with remifentanil + propofol |
|
| General Anesthesia - Group 1 | Experimental | General anesthesia (GA) with Sevoflurane + O2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aman Mahajan, MD, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sedation - Group 1 | Sedation - monitored anesthesia with propofol. Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. |
| FG001 | Sedation - Group 2 | Sedation - monitored anesthesia with ketamine + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Ketamine: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. |
| FG002 | Sedation - Group 3 | Sedation - monitored anesthesia with remifentanil + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Remifentanil: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. |
| FG003 | General Anesthesia - Group 1 | General anesthesia (GA) with Sevoflurane + O2 Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sedation - Group 1 | Sedation - monitored anesthesia with propofol. Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. |
| BG001 | Sedation - Group 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours. |
|
Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sedation - Group 1 | Sedation - monitored anesthesia with propofol. Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| New onset atrial fibrillation requiring cardioversion | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| slow ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Scovotti | University of California, Los Angeles | 310.206.4484 | jscovotti@mednet.ucla.edu |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D007649 | Ketamine |
| D000077208 | Remifentanil |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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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. |
|
|
| Remifentanil | Drug | 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. |
|
|
| Sevoflurane | Drug | 1 general anesthesia group for VT ablations and afib procedures. |
|
|
| 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 |
Sedation - monitored anesthesia with ketamine + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Ketamine: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. |
| BG002 | Sedation - Group 3 | Sedation - monitored anesthesia with remifentanil + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Remifentanil: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. |
| BG003 | General Anesthesia - Group 1 | General anesthesia (GA) with Sevoflurane + O2 Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Sedation - Group 3 | Sedation - monitored anesthesia with remifentanil + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Remifentanil: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. |
| OG003 | General Anesthesia - Group 1 | General anesthesia (GA) with Sevoflurane + O2 Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures. |
|
|
| Primary | 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". | Posted | Mean | Standard Deviation | score on a scale | Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours. |
|
|
|
| Secondary | 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. | Patients were excluded from analysis if there was no electrophysiology follow-up in the medical record 1-3 months postoperatively. | Posted | Count of Participants | Participants | 1-3 months postoperatively |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Sedation - Group 2 | Sedation - monitored anesthesia with ketamine + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Ketamine: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. | 0 | 12 | 2 | 12 | 2 | 12 |
| EG002 | Sedation - Group 3 | Sedation - monitored anesthesia with remifentanil + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Remifentanil: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG003 | General Anesthesia - Group 1 | General anesthesia (GA) with Sevoflurane + O2 Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures. | 1 | 5 | 1 | 5 | 0 | 5 |
| Cardiac Arrest | Cardiac disorders | Non-systematic Assessment |
|
| VA ECMO | Cardiac disorders | Non-systematic Assessment |
|
| Multiorgan Failure | Cardiac disorders | Non-systematic Assessment |
|
| Death | Cardiac disorders | Non-systematic Assessment |
|
| Hyperkalemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
|
| non-sustained ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Pericardial Drain | Cardiac disorders | Non-systematic Assessment |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |