Anesthetic Techniques in EP Patients

University of California, Los Angeles (UCLA)

Status and phase: Terminated; Phase 4

Conditions: Cardiac Disease

Treatments: Drug: Ketamine; Drug: Sevoflurane; Drug: Propofol; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT02664922

Anes Tech 11-003514

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 4 patient groups

Sedation - Group 1

Experimental group

Description:

Sedation - monitored anesthesia with propofol.

Treatment:

Drug: Propofol

Sedation - Group 2

Experimental group

Description:

Sedation - monitored anesthesia with ketamine + propofol

Treatment:

Drug: Propofol

Drug: Ketamine

Sedation - Group 3

Experimental group

Description:

Sedation - monitored anesthesia with remifentanil + propofol

Treatment:

Drug: Remifentanil

Drug: Propofol

General Anesthesia - Group 1

Experimental group

Description:

General anesthesia (GA) with Sevoflurane + O2

Treatment:

Drug: Sevoflurane