Ventricular Tachycardia
Conditions
Keywords
Ventricular tachycardia, ventricular tachycardia ablation, effects of anesthesia on VT induction, programed stimulation
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.
Interventions
DRUGVersed
Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia
DRUGFentanyl
Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia
DRUGPropofol
Phase 2: Standard induction of GETA with intravenous agent then programed stimulation to induce ventricular tachycardia
DRUGSevoflurane
Phase 3: Standard induction of GETA with inhalent agent then programed stimulation to induce ventricular tachycardia
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Inducible Ventricular Tachycardia Under General Anesthesia. | While under General Anesthesia, an average of 6 hours | 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). |
Countries
United States
Participant flow
Recruitment details
Subjects undergoing VT ablation were enrolled over 1 year period
Participants by arm
| Arm | Count |
|---|---|
| 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 | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Anesthesia Induction |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 1 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
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).
Time frame: While under General Anesthesia, an average of 6 hours
Population: All participants who underwent general anesthesia and programed stimulation during VT ablation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ventriuclar Tachycardia Induction | Number of Participants Who Had Inducible Ventricular Tachycardia Under General Anesthesia. | Phase 1 Concious Sedation | 7 participants |
| Ventriuclar Tachycardia Induction | Number of Participants Who Had Inducible Ventricular Tachycardia Under General Anesthesia. | Phase 2 Propofol | 5 participants |
| Ventriuclar Tachycardia Induction | Number of Participants Who Had Inducible Ventricular Tachycardia Under General Anesthesia. | Phase 3 Sevoflurane | 5 participants |