Clinical trial NCT02664922: Anesthetic Techniques in EP Patients
Official title: Anesthetic Techniques and the Effect on Cardiac Electrophysiology Procedures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cardiac Disease
Keywords: Electrophysiology
Anesthetics
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Adverse Events.
timeFrame: Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
measure: Effectiveness of Anesthetic Drugs in Terms of Pain Relief.
timeFrame: Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
measure: Effectiveness of Anesthetic Drugs in Terms of Patient Comfort.
timeFrame: Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
measure: Effectiveness of Anesthetic Drugs in Terms of Patient Satisfaction.
timeFrame: Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
Secondary outcomes:
measure: Effectiveness of Anesthetic Drugs in Terms of Proceduralist Satisfaction.
timeFrame: Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
measure: Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Clinical Success.
timeFrame: 1-3 months postoperatively
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Aman Mahajan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: