Cardiac Disease
Conditions
Keywords
Electrophysiology, Anesthetics
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.
Interventions
DRUGPropofol
1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
DRUGKetamine
1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
DRUGRemifentanil
1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
DRUGSevoflurane
1 general anesthesia group for VT ablations and afib procedures.
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Adverse Events. | 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. | 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. | 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. |
| Effectiveness of Anesthetic Drugs in Terms of Patient Satisfaction. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Anesthetic Drugs in Terms of Proceduralist Satisfaction. | Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours. | 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. |
| Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Clinical Success. | 1-3 months postoperatively | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 12 |
| 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. | 7 |
| General Anesthesia - Group 1 General anesthesia (GA) with Sevoflurane + O2
Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures. | 5 |
| Total | 34 |
Baseline characteristics
| Characteristic | Sedation - Group 1 | Sedation - Group 2 | Sedation - Group 3 | General Anesthesia - Group 1 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 16 | 56 years STANDARD_DEVIATION 13 | 48 years STANDARD_DEVIATION 18 | 43 years STANDARD_DEVIATION 16 | 53 years STANDARD_DEVIATION 16 |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 2 Participants | 1 Participants | 13 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 5 Participants | 4 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 12 | 0 / 7 | 1 / 5 |
| other Total, other adverse events | 1 / 10 | 2 / 12 | 0 / 7 | 0 / 5 |
| serious Total, serious adverse events | 0 / 10 | 2 / 12 | 0 / 7 | 1 / 5 |
Outcome results
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.
Time frame: Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sedation - Group 1 | Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Adverse Events. | 1 Participants |
| Sedation - Group 2 | Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Adverse Events. | 2 Participants |
| Sedation - Group 3 | Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Adverse Events. | 0 Participants |
| General Anesthesia - Group 1 | Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Adverse Events. | 0 Participants |
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.
Time frame: Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedation - Group 1 | Effectiveness of Anesthetic Drugs in Terms of Pain Relief. | 1.7 score on a scale | Standard Deviation 1.3 |
| Sedation - Group 2 | Effectiveness of Anesthetic Drugs in Terms of Pain Relief. | 0.4 score on a scale | Standard Deviation 0.5 |
| Sedation - Group 3 | Effectiveness of Anesthetic Drugs in Terms of Pain Relief. | 0.2 score on a scale | Standard Deviation 0.5 |
| General Anesthesia - Group 1 | Effectiveness of Anesthetic Drugs in Terms of Pain Relief. | 0 score on a scale | Standard Deviation 0 |
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.
Time frame: Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedation - Group 1 | Effectiveness of Anesthetic Drugs in Terms of Patient Comfort. | 2.9 score on a scale | Standard Deviation 1.2 |
| Sedation - Group 2 | Effectiveness of Anesthetic Drugs in Terms of Patient Comfort. | 3.0 score on a scale | Standard Deviation 1.3 |
| Sedation - Group 3 | Effectiveness of Anesthetic Drugs in Terms of Patient Comfort. | 3.0 score on a scale | Standard Deviation 1.3 |
| General Anesthesia - Group 1 | Effectiveness of Anesthetic Drugs in Terms of Patient Comfort. | 1.0 score on a scale | Standard Deviation 0 |
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.
Time frame: Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedation - Group 1 | Effectiveness of Anesthetic Drugs in Terms of Patient Satisfaction. | 3.4 score on a scale | Standard Deviation 0.4 |
| Sedation - Group 2 | Effectiveness of Anesthetic Drugs in Terms of Patient Satisfaction. | 3.0 score on a scale | Standard Deviation 0.7 |
| Sedation - Group 3 | Effectiveness of Anesthetic Drugs in Terms of Patient Satisfaction. | 3.5 score on a scale | Standard Deviation 0.5 |
| General Anesthesia - Group 1 | Effectiveness of Anesthetic Drugs in Terms of Patient Satisfaction. | 3.1 score on a scale | Standard Deviation 0.1 |
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.
Time frame: 1-3 months postoperatively
Population: Patients were excluded from analysis if there was no electrophysiology follow-up in the medical record 1-3 months postoperatively.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sedation - Group 1 | Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Clinical Success. | 0 Participants |
| Sedation - Group 2 | Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Clinical Success. | 0 Participants |
| Sedation - Group 3 | Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Clinical Success. | 1 Participants |
| General Anesthesia - Group 1 | Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Clinical Success. | 1 Participants |
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.
Time frame: Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedation - Group 1 | Effectiveness of Anesthetic Drugs in Terms of Proceduralist Satisfaction. | 5.7 score on a scale | Standard Deviation 0.4 |
| Sedation - Group 2 | Effectiveness of Anesthetic Drugs in Terms of Proceduralist Satisfaction. | 5.6 score on a scale | Standard Deviation 0.5 |
| Sedation - Group 3 | Effectiveness of Anesthetic Drugs in Terms of Proceduralist Satisfaction. | 5.2 score on a scale | Standard Deviation 0.3 |
| General Anesthesia - Group 1 | Effectiveness of Anesthetic Drugs in Terms of Proceduralist Satisfaction. | 5.1 score on a scale | Standard Deviation 1.9 |