Remifentanil Intravenous Patient Controlled Analgesia (IVPCA) for Ablation of Idiopathic Ventricular Tachycardia (IVPCA)
|ClinicalTrials.gov Identifier: NCT01901575|
Recruitment Status : Completed
First Posted : July 17, 2013
Results First Posted : December 19, 2014
Last Update Posted : January 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Tachycardia, Ventricular||Drug: Remifentanil||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Remifentanil IV PCA for Ablation of Idiopathic Ventricular Tachycardia|
|Actual Study Start Date :||July 2011|
|Primary Completion Date :||April 2013|
|Study Completion Date :||April 2013|
U.S. FDA Resources
Experimental: Remifentanil IV PCA
patients with PVC's prior to administration of remifentanil
Patients with established PVC's , sedated with remifentanil IVPCA per study protocol
Other Name: Ultiva
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901575
|United States, New York|
|NYU Langone Medical Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Misha Kogan, MD||NYU School of Medicine|