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

NCT01901575 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 11-00800
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Tachycardia, Ventricular

Keywords

idiopathic ventricular tachycardia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Remifentanil IV PCA

EXPERIMENTAL

patients with PVC's prior to administration of remifentanil

Drug: Remifentanil

Interventions

Remifentanil DRUG

Patients with established PVC's , sedated with remifentanil IVPCA per study protocol

Also known as: Ultiva

Remifentanil IV PCA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• ASA 4 and 5
• Age 18 and 65

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 18783026 BACKGROUND

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Avrimin M. Kogan, MD
• Organization: NYU Langone Medical Center

Avrimin.Kogan@nyumc.org

(212) 263-5072

Study Officials

• Misha Kogan, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: July 17, 2013
• Study Start: July 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 2, 2018
• Results First Posted: December 19, 2014

Record last verified: 2017-12

Locations

US (1)