Remifentanil Intravenous Patient Controlled Analgesia (IVPCA) for Ablation of Idiopathic Ventricular Tachycardia - Full Text View

Purpose

Determine effects of remifentanil conscious sedation in patients undergoing Electrophysiological (EP) studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent premature ventricular contractions (PVCs) of non-ischemic origin

Condition	Intervention
Tachycardia, Ventricular	Drug: Remifentanil


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Remifentanil IV PCA for Ablation of Idiopathic Ventricular Tachycardia

Resource links provided by NLM:

Genetics Home Reference related topics: catecholaminergic polymorphic ventricular tachycardia

Drug Information available for: Remifentanil hydrochloride

U.S. FDA Resources

Further study details as provided by Avrimin M Kogan, MD, New York University School of Medicine:

Primary Outcome Measures:

Inhibition of Idiopathic Ventricular Tachycardia [ Time Frame: duration of the procedure or until the presence of PVC's was no longer required for the cardiologist to complete the ablation, average 2 hours ]
observation of the anesthetic effect on the inhibition of the ventricular tachycardia in patients undergoing radio-frequency ablation of idiopathic ventricular tachycardia. Patients were continuously monitored for presence of PVC's.

Every 15 minutes patient's heart rhythm (EKG) was documented on the anesthetic record. Presence of PVC's of the same morphology was confirmed by the cardiologist performing the ablation.
PVC Suppression With Remifentanil Sedation [ Time Frame: duration of the operative procedure, average 2 hours ]
1 observed suppression of PVC's (PVC's of the same morphology are no longer observed during any 15 minute recording interval) 0 no suppression


Enrollment:	16
Study Start Date:	July 2011
Study Completion Date:	April 2013
Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Remifentanil IV PCA patients with PVC's prior to administration of remifentanil	Drug: Remifentanil Patients with established PVC's , sedated with remifentanil IVPCA per study protocol Other Name: Ultiva

Detailed Description:

The purpose of the study is to determine the effects of remifentanil conscious sedation in patients undergoing Electrophysiological (EP) studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent PVCs of non-ischemic origin.

Remifentanil is an analgesic- synthetic opiate with an very short half life. It is rapidly broken down by enzymes in the blood and is ideally suited for continuous sedation. The effect is practically eliminated within 5 minutes after the intravenous sedation is stopped.

You are being asked to participate in this study because you are already scheduled to undergo EP studies under the care of your cardiologist for the ablation of idiopathic ventricular tachycardia and/or persistent frequent PVCs of non-ischemic origin.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients scheduled to undergo EP studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent PVCs of non-ischemic origin
Patients between 18 and 65
ASA 1-3

Exclusion Criteria:

ASA 4 and 5
Age 18 and 65

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01901575

Locations


United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016

Sponsors and Collaborators

New York University School of Medicine

Investigators


Principal Investigator:	Misha Kogan, MD	NYU School of Medicine

More Information

Publications:

Garofalo NA, Teixeira-Neto FJ, Schwartz DS, Vailati Mdo C, Steagall PV. Effects of the opioid remifentanil on the arrhythmogenicity of epinephrine in halothane-anesthetized dogs. Can J Vet Res. 2008 Jul;72(4):362-6.


Responsible Party:	Avrimin M Kogan, MD, Clinical Assistant Professor, New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT01901575 History of Changes
Other Study ID Numbers:	11-00800
Study First Received:	April 16, 2013
Results First Received:	December 11, 2014
Last Updated:	May 9, 2015

Keywords provided by Avrimin M Kogan, MD, New York University School of Medicine:


idiopathic ventricular tachycardia

Additional relevant MeSH terms:


Tachycardia, Ventricular Tachycardia Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Remifentanil Analgesics, Opioid Narcotics	Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics

ClinicalTrials.gov processed this record on September 19, 2017

Remifentanil Intravenous Patient Controlled Analgesia (IVPCA) for Ablation of Idiopathic Ventricular Tachycardia (IVPCA)