Anesthetic Techniques in EP Patients

September 21, 2020 updated by: University of California, Los Angeles

Anesthetic Techniques and the Effect on Cardiac Electrophysiology Procedures

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sedation - Group 1
Sedation - monitored anesthesia with propofol.
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 Names:
  • Diprivan
Experimental: Sedation - Group 2
Sedation - monitored anesthesia with ketamine + propofol
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 Names:
  • 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 Names:
  • Ketalar
Experimental: Sedation - Group 3
Sedation - monitored anesthesia with remifentanil + propofol
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 Names:
  • Diprivan
Drug: Remifentanil
1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
Other Names:
  • Ultiva
Experimental: General Anesthesia - Group 1
General anesthesia (GA) with Sevoflurane + O2
Drug: Sevoflurane
1 general anesthesia group for VT ablations and afib procedures.
Other Names:
  • Ultane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
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".
Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
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.
Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
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.
Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
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.
1-3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 5, 2014

First Submitted That Met QC Criteria

January 22, 2016

First Posted (Estimate)

January 27, 2016

Study Record Updates

Last Update Posted (Actual)

September 22, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anes Tech 11-003514

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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