Anesthetic Techniques in EP Patients
Primary Purpose
Cardiac Disease
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Propofol
Ketamine
Remifentanil
Sevoflurane
Sponsored by

About this trial
This is an interventional other trial for Cardiac Disease focused on measuring Electrophysiology, Anesthetics
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)
Sites / Locations
- Ronald Reagan UCLA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Sedation - Group 1
Sedation - Group 2
Sedation - Group 3
General Anesthesia - Group 1
Arm Description
Sedation - monitored anesthesia with propofol.
Sedation - monitored anesthesia with ketamine + propofol
Sedation - monitored anesthesia with remifentanil + propofol
General anesthesia (GA) with Sevoflurane + O2
Outcomes
Primary Outcome Measures
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.
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".
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02664922
First Posted
October 5, 2014
Last Updated
September 21, 2020
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT02664922
Brief Title
Anesthetic Techniques in EP Patients
Official Title
Anesthetic Techniques and the Effect on Cardiac Electrophysiology Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Poor study design and too many study groups.
Study Start Date
May 2012 (Actual)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease
Keywords
Electrophysiology, Anesthetics
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sedation - Group 1
Arm Type
Experimental
Arm Description
Sedation - monitored anesthesia with propofol.
Arm Title
Sedation - Group 2
Arm Type
Experimental
Arm Description
Sedation - monitored anesthesia with ketamine + propofol
Arm Title
Sedation - Group 3
Arm Type
Experimental
Arm Description
Sedation - monitored anesthesia with remifentanil + propofol
Arm Title
General Anesthesia - Group 1
Arm Type
Experimental
Arm Description
General anesthesia (GA) with Sevoflurane + O2
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
1 of 2 sedation groups for VT ablation and afib procedures.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalar
Intervention Description
1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
1 of 2 sedation groups for VT ablation and afib procedures.
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Ultiva
Intervention Description
1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Ultane
Intervention Description
1 general anesthesia group for VT ablations and afib procedures.
Primary Outcome Measure Information:
Title
Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Adverse Events.
Description
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.
Title
Effectiveness of Anesthetic Drugs in Terms of Pain Relief.
Description
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.
Title
Effectiveness of Anesthetic Drugs in Terms of Patient Comfort.
Description
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.
Title
Effectiveness of Anesthetic Drugs in Terms of Patient Satisfaction.
Description
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.
Secondary Outcome Measure Information:
Title
Effectiveness of Anesthetic Drugs in Terms of Proceduralist Satisfaction.
Description
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.
Title
Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Clinical Success.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aman Mahajan, MD, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Anesthetic Techniques in EP Patients
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