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Anesthetic Techniques in EP Patients

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

Tracking Information
First Submitted Date  ICMJE October 5, 2014
First Posted Date  ICMJE January 27, 2016
Results First Submitted Date  ICMJE September 3, 2020
Results First Posted Date  ICMJE September 22, 2020
Last Update Posted Date September 22, 2020
Actual Study Start Date  ICMJE May 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Anesthetic Techniques in EP Patients
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Other
Condition  ICMJE Cardiac Disease
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 10, 2020)
35
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2016)
120
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02664922
Other Study ID Numbers  ICMJE Anes Tech 11-003514
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aman Mahajan, MD, PhD University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP