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

NCT ID: NCT01901575

Last Updated: 2018-01-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-04-30

Brief Summary

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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

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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.

Conditions

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Tachycardia, Ventricular

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Remifentanil IV PCA

patients with PVC's prior to administration of remifentanil

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

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

Interventions

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Remifentanil

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

Intervention Type DRUG

Other Intervention Names

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Ultiva

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Misha Kogan, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

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NYU Langone Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18783026 (View on PubMed)

Other Identifiers

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11-00800

Identifier Type: -

Identifier Source: org_study_id

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