Overview

This trial is active, not recruiting.

Condition cardiac disease
Treatments propofol, ketamine, remifentanil, sevoflurane
Phase phase 4
Sponsor University of California, Los Angeles
Start date May 2012
End date December 2016
Trial size 120 participants
Trial identifier NCT02664922, Anes Tech 11-003514

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (caregiver)
Arm
(Experimental)
Sedation - monitored anesthesia with propofol.
propofol Diprivan
1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
(Experimental)
Sedation - monitored anesthesia with ketamine + propofol
propofol Diprivan
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 Ketalar
1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
(Experimental)
Sedation - monitored anesthesia with remifentanil + propofol
propofol Diprivan
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 Ultiva
1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
(Experimental)
General anesthesia (GA) with Sevoflurane + O2
sevoflurane Ultane
1 general anesthesia group for VT ablations and afib procedures.

Primary Outcomes

Measure
Effectiveness of anesthetic drugs in terms of adverse effects.
time frame: 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.
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.

Secondary Outcomes

Measure
Effectiveness of anesthetic drugs in terms of identification and treatment of arrhythmias.
time frame: Intraoperatively to 3 months postoperatively

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Anesthetic Techniques and the Effect on Cardiac Electrophysiology Procedures
Principal investigator Aman Mahajan, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of California, Los Angeles.