Inducibility and Stability of Ventricular Tachycardia Inpatients Undergoing VT Ablation Under General Anesthesia

NCT ID: NCT02419547

Last Updated: 2019-10-09

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

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-04-26

Brief Summary

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This research study is being done to see whether general anesthesia (GA) affects our ability to start ventricular tachycardia (VT) during an VT ablation procedure.

Data collected during this research study will help electrophysiologists and anesthesiologists to make the best decisions about the best anesthetic conditions to use to perform VT ablations.

This research study is a "pilot" study. Pilot studies are done on a small group of subjects to learn if a larger study would be useful.

Detailed Description

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Conditions

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Ventricular Tachycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Anesthesia Induction

Patients undergoing ventricular tachycardia ablation will undergo programmed stimulation (PS) with minimal sedation (Versed, Fentanyl), with intravenous agents (propofol) , and finally with volatile inhalational agent (sevoflurane).

Group Type OTHER

Versed

Intervention Type DRUG

Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia

Fentanyl

Intervention Type DRUG

Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia

Propofol

Intervention Type DRUG

Phase 2: Standard induction of GETA with intravenous agent then programed stimulation to induce ventricular tachycardia

Sevoflurane

Intervention Type DRUG

Phase 3: Standard induction of GETA with inhalent agent then programed stimulation to induce ventricular tachycardia

Interventions

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Versed

Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia

Intervention Type DRUG

Fentanyl

Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia

Intervention Type DRUG

Propofol

Phase 2: Standard induction of GETA with intravenous agent then programed stimulation to induce ventricular tachycardia

Intervention Type DRUG

Sevoflurane

Phase 3: Standard induction of GETA with inhalent agent then programed stimulation to induce ventricular tachycardia

Intervention Type DRUG

Other Intervention Names

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midazolam Duragesic Diprivan Ultane

Eligibility Criteria

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Inclusion Criteria

* Patients with VT and have an implanted ICD who are scheduled for VT catheter ablation.
* Patients 18 years of age or older

Exclusion Criteria

* Patients with difficult airway management or patients with contra/ relative contra indication for general anesthesia or known allergies to any of the proposed anesthetic agents
* Women who are pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Douglas Shook

Chief, Divison of Cardiac Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wendy L Gross, M.D.

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigahm and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2013-P-000241

Identifier Type: -

Identifier Source: org_study_id

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