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

Remifentanil IV PCA for Ablation of Idiopathic Ventricular Tachycardia

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

Study Overview

• Status: Completed
• Conditions: Tachycardia, Ventricular
• Intervention / Treatment: Drug: Remifentanil

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Ultiva

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inhibition of Idiopathic Ventricular Tachycardia	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.	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
PVC Suppression With Remifentanil Sedation	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	duration of the operative procedure, average 2 hours

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Misha Kogan, MD, NYU School of Medicine

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: April 16, 2013
• First Submitted That Met QC Criteria: July 12, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Actual): January 2, 2018
• Last Update Submitted That Met QC Criteria: December 7, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: idiopathic ventricular tachycardia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: 11-00800

Drug and device information, study documents

• 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