Trial Outcomes & Findings for Inducibility and Stability of Ventricular Tachycardia Inpatients Undergoing VT Ablation Under General Anesthesia (NCT NCT02419547)

NCT ID: NCT02419547

Last Updated: 2019-10-09

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

While under General Anesthesia, an average of 6 hours

Results posted on

2019-10-09

Participant Flow

Subjects undergoing VT ablation were enrolled over 1 year period

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anesthesia Induction n=11 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: While under General Anesthesia, an average of 6 hours

Population: All participants who underwent general anesthesia and programed stimulation during VT ablation.

Outcome measures

Outcome measures
Measure	Ventriuclar Tachycardia Induction n=11 Participants 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
Number of Participants Who Had Inducible Ventricular Tachycardia Under General Anesthesia. Phase 1 Concious Sedation	7 participants
Number of Participants Who Had Inducible Ventricular Tachycardia Under General Anesthesia. Phase 2 Propofol	5 participants
Number of Participants Who Had Inducible Ventricular Tachycardia Under General Anesthesia. Phase 3 Sevoflurane	5 participants

Adverse Events

Anesthesia Induction

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Anesthesia Induction n=11 participants at risk 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
Surgical and medical procedures hematoma not requiring blood transfusion	9.1% 1/11 • Number of events 1 • 30 days There will be a 7 day follow up phone call and a 30 day visit to assess for AE's.

Additional Information

Douglas Shook, MD, Chief, Divison of Cardiac Anesthesia

Brigham and Women's Hospital

Phone: 617-732-8219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place