Remifentanil Intravenous Patient Controlled Analgesia (IVPCA) for Ablation of Idiopathic Ventricular Tachycardia (IVPCA)
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| ClinicalTrials.gov Identifier: NCT01901575 |
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Recruitment Status :
Completed
First Posted : July 17, 2013
Results First Posted : December 19, 2014
Last Update Posted : January 2, 2018
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| 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) |
| Primary Purpose: | Treatment |
| Official Title: | Remifentanil IV PCA for Ablation of Idiopathic Ventricular Tachycardia |
| Actual Study Start Date : | July 2011 |
| Actual Primary Completion Date : | April 2013 |
| Actual Study Completion Date : | April 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Remifentanil IV PCA
patients with PVC's prior to administration of remifentanil
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Drug: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 |
Publications:
| Responsible Party: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01901575 History of Changes |
| Other Study ID Numbers: |
11-00800 |
| First Posted: | July 17, 2013 Key Record Dates |
| Results First Posted: | December 19, 2014 |
| Last Update Posted: | January 2, 2018 |
| Last Verified: | December 2017 |
| 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 | |
Keywords provided by New York University School of Medicine:
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idiopathic ventricular tachycardia |
Additional relevant MeSH terms:
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Tachycardia, Ventricular Tachycardia Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Remifentanil Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics |