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

NCT02419547 | Completed Results

• 1 other identifier: 2013-P-000241
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventricular Tachycardia

Keywords

Ventricular tachycardia; ventricular tachycardia ablation; effects of anesthesia on VT induction; programed stimulation

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Had Inducible Ventricular Tachycardia Under General Anesthesia.

  Patients before induction of GA undergo noninvasive programmed stimulation (NIPS) using the patient's ICD. Subjects receive minimal versed/fentanyl during the NIPS. The anesthesiologist will decide whether to use propofol prior to the second induction, depending on the patient's cardiac function and hemodynamic status. After induction of GA with IV propofol, programmed stimulation will be performed from the RV catheter. Mapping under volatile agent will commence any time after twice the redistribution half-life of either agent has elapsed (propofol 4-16 mins) or have passed. Once the drug is out of the central compartment it is unlikely to affect myocardial electrolytes or ion channels. GA will be maintained with an inhalation agent, sevoflurane. A repeat programmed stimulation test will be performed. Endpoint for programmed stimulation will be induction of sustained monomorphic VT (SMVT).

  While under General Anesthesia, an average of 6 hours

Study Arms (1)

Anesthesia Induction

OTHER

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).

Drug: Versed; Drug: Fentanyl; Drug: Propofol; Drug: Sevoflurane

Interventions

Versed DRUG

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

Also known as: midazolam

Anesthesia Induction

Fentanyl DRUG

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

Also known as: Duragesic

Anesthesia Induction

Propofol DRUG

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

Also known as: Diprivan

Anesthesia Induction

Sevoflurane DRUG

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

Also known as: Ultane

Anesthesia Induction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigahm and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Midazolam; Fentanyl; Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Results Point of Contact

• Title: Douglas Shook, MD, Chief, Divison of Cardiac Anesthesia
• Organization: Brigham and Women's Hospital

dshook@bwh.harvard.edu

617-732-8219

Study Officials

• Wendy L Gross, M.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Divison of Cardiac Anesthesia

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: April 17, 2015
• Study Start: July 1, 2014
• Primary Completion: April 26, 2015
• Study Completion: April 26, 2015
• Last Updated: October 9, 2019
• Results First Posted: October 9, 2019

Record last verified: 2019-09

Locations

US (1)