Anesthetic Techniques in EP Patients

• ClinicalTrials.gov Identifier: NCT02664922
• Recruitment Status: Terminated
• First Posted: January 27, 2016
• Results First Posted: September 22, 2020
• Last Update Posted: September 22, 2020
• Sponsor: University of California, Los Angeles
• Information provided by (Responsible Party): University of California, Los Angeles

Tracking Information

• First Submitted Date: October 5, 2014
• First Posted Date: January 27, 2016
• Results First Submitted Date: September 3, 2020
• Results First Posted Date: September 22, 2020
• Last Update Posted Date: September 22, 2020
• Actual Study Start Date: May 2012
• Actual Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 21, 2020)

• 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.
• 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.

Original Primary Outcome Measures (submitted: January 22, 2016)

• Effectiveness of anesthetic drugs in terms of adverse effects. [ 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.
• 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.
• Effectiveness of anesthetic drugs in terms of patient comfort and satisfaction. [ 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. Patients will also be asked to complete a written questionnaire prior to discharge from the hospital to measure patient satisfaction during their anesthesia care.

Current Secondary Outcome Measures (submitted: September 21, 2020)

• Effectiveness of Anesthetic Drugs in Terms of Proceduralist Satisfaction. [ Time Frame: 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. [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: January 22, 2016)

Effectiveness of anesthetic drugs in terms of identification and treatment of arrhythmias. [ Time Frame: Intraoperatively to 3 months postoperatively ]

The proceduralist will also complete a written questionnaire after the procedure to rate their satisfaction and follow-up 1-3 months post-procedure to evaluate clinical success.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Anesthetic Techniques in EP Patients
• Official Title: Anesthetic Techniques and the Effect on Cardiac Electrophysiology Procedures
• 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Care Provider); Primary Purpose: Other
• Condition: Cardiac Disease

Intervention

• Drug: 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.

  Other Name: Diprivan
• Drug: 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.

  Other Name: Ketalar
• Drug: Remifentanil
  1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
  Other Name: Ultiva
• Drug: Sevoflurane
  1 general anesthesia group for VT ablations and afib procedures.
  Other Name: Ultane

Study Arms

• Experimental: Sedation - Group 1
  Sedation - monitored anesthesia with propofol.
  Intervention: Drug: Propofol
• Experimental: Sedation - Group 2
  Sedation - monitored anesthesia with ketamine + propofol
  Interventions:

  • Drug: Propofol
  • Drug: Ketamine
• Experimental: Sedation - Group 3
  Sedation - monitored anesthesia with remifentanil + propofol
  Interventions:

  • Drug: Propofol
  • Drug: Remifentanil
• Experimental: General Anesthesia - Group 1
  General anesthesia (GA) with Sevoflurane + O2
  Intervention: Drug: Sevoflurane

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: January 10, 2020): 35
• Original Estimated Enrollment (submitted: January 22, 2016): 120
• Actual Study Completion Date: December 2013
• Actual Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02664922
• Other Study ID Numbers: Anes Tech 11-003514
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: University of California, Los Angeles
• Study Sponsor: University of California, Los Angeles
• Collaborators: Not Provided

Investigators

• Principal Investigator: Aman Mahajan, MD, PhD; University of California, Los Angeles

• PRS Account: University of California, Los Angeles
• Verification Date: September 2020