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

Phase 4

Completed

• Conditions: Tachycardia, Ventricular
• Interventions: Drug: Remifentanil

• Registration Number: NCT01901575
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2013-04-16
• Study First Submitted QC: 2013-07-12
• Study First Posted: 2013-07-17
• Results First Submitted: 2014-12-11
• Results First Submitted QC: 2014-12-11
• Results First Posted: 2014-12-19
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-07
• Last Update Posted: 2018-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remifentanil IV PCA	Remifentanil	patients with PVC's prior to administration of remifentanil

Primary Outcome Measures

Name	Time	Method
Inhibition of Idiopathic Ventricular Tachycardia	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	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

Trial Locations

Locations (1)

NYU Langone Medical Center; 🇺🇸 New York, New York, United States