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

Primary Purpose

Tachycardia, Ventricular

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Remifentanil
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tachycardia, Ventricular focused on measuring idiopathic ventricular tachycardia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Langone Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Remifentanil IV PCA

Arm Description

patients with PVC's prior to administration of remifentanil

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
April 16, 2013
Last Updated
December 7, 2017
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT01901575
Brief Title
Remifentanil Intravenous Patient Controlled Analgesia (IVPCA) for Ablation of Idiopathic Ventricular Tachycardia
Acronym
IVPCA
Official Title
Remifentanil IV PCA for Ablation of Idiopathic Ventricular Tachycardia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
July 2011 (Actual)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia, Ventricular
Keywords
idiopathic ventricular tachycardia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remifentanil IV PCA
Arm Type
Experimental
Arm Description
patients with PVC's prior to administration of remifentanil
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Ultiva
Intervention Description
Patients with established PVC's , sedated with remifentanil IVPCA per study protocol
Primary Outcome Measure Information:
Title
Inhibition of Idiopathic Ventricular Tachycardia
Description
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.
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
Title
PVC Suppression With Remifentanil Sedation
Description
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
Time Frame
duration of the operative procedure, average 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Misha Kogan, MD
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18783026
Citation
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.
Results Reference
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Remifentanil Intravenous Patient Controlled Analgesia (IVPCA) for Ablation of Idiopathic Ventricular Tachycardia

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