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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Tachycardia, Ventricular	Drug: Remifentanil	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	16 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Remifentanil IV PCA for Ablation of Idiopathic Ventricular Tachycardia
Actual Study Start Date :	July 2011
Actual Primary Completion Date :	April 2013
Actual Study Completion Date :	April 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 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

Outcome Measures

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Primary Outcome Measures :

1. 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.

2. 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

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT01901575 History of Changes
Other Study ID Numbers:	11-00800
First Posted:	July 17, 2013
Results First Posted:	December 19, 2014
Last Update Posted:	January 2, 2018
Last Verified:	December 2017

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No
Product Manufactured in and Exported from the U.S.:		No

Keywords provided by 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