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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Versed | Drug | Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy L Gross, M.D. | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigahm and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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Subjects undergoing VT ablation were enrolled over 1 year period
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). Versed: Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia Fentanyl: Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia Propofol: Phase 2: Standard induction of GETA with intravenous agent then programed stimulation to induce ventricular tachycardia Sevoflurane: Phase 3: Standard induction of GETA with inhalent agent then programed stimulation to induce ventricular tachycardia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). Versed: Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia Fentanyl: Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia Propofol: Phase 2: Standard induction of GETA with intravenous agent then programed stimulation to induce ventricular tachycardia Sevoflurane: Phase 3: Standard induction of GETA with inhalent agent then programed stimulation to induce ventricular tachycardia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All participants who underwent general anesthesia and programed stimulation during VT ablation. | Posted | Number | participants | While under General Anesthesia, an average of 6 hours |
30 days
There will be a 7 day follow up phone call and a 30 day visit to assess for AE's.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). Versed: Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia Fentanyl: Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia Propofol: Phase 2: Standard induction of GETA with intravenous agent then programed stimulation to induce ventricular tachycardia Sevoflurane: Phase 3: Standard induction of GETA with inhalent agent then programed stimulation to induce ventricular tachycardia |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hematoma not requiring blood transfusion | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Douglas Shook, MD, Chief, Divison of Cardiac Anesthesia | Brigham and Women's Hospital | 617-732-8219 | dshook@bwh.harvard.edu |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D005283 | Fentanyl |
| D015742 | Propofol |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Fentanyl | Drug | Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia |
|
|
| Propofol | Drug | Phase 2: Standard induction of GETA with intravenous agent then programed stimulation to induce ventricular tachycardia |
|
|
| Sevoflurane | Drug | Phase 3: Standard induction of GETA with inhalent agent then programed stimulation to induce ventricular tachycardia |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Ventriuclar Tachycardia 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). Versed: Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia Fentanyl: Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia Propofol: Phase 2: Standard induction of GETA with intravenous agent then programed stimulation to induce ventricular tachycardia Sevoflurane: Phase 3: Standard induction of GETA with inhalent agent then programed stimulation to induce ventricular tachycardia |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 1 |
| 11 |
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| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |