Anesthetic Techniques in EP Patients

NCT ID: NCT02664922

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-12-31

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.

Conditions

Cardiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Sedation - Group 1

Sedation - monitored anesthesia with propofol.

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.

1 of 2 sedation groups for VT ablation and afib procedures.

Sedation - Group 2

Sedation - monitored anesthesia with ketamine + propofol

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

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

Intervention Type: DRUG

1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.

1 of 2 sedation groups for VT ablation and afib procedures.

Sedation - Group 3

Sedation - monitored anesthesia with remifentanil + propofol

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

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

Intervention Type: DRUG

1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.

General Anesthesia - Group 1

General anesthesia (GA) with Sevoflurane + O2

Group Type: EXPERIMENTAL

Sevoflurane

Intervention Type: DRUG

1 general anesthesia group for VT ablations and afib procedures.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Remifentanil

1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.

Intervention Type: DRUG

Sevoflurane

1 general anesthesia group for VT ablations and afib procedures.

Intervention Type: DRUG

Other Intervention Names

Diprivan; Ketalar; Ultiva; Ultane

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aman Mahajan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

Anes Tech 11-003514

Identifier Type: -

Identifier Source: org_study_id