Tachycardia, Ventricular
Conditions
Keywords
idiopathic ventricular tachycardia
Brief summary
Determine effects of remifentanil conscious sedation in patients undergoing Electrophysiological (EP) studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent premature ventricular contractions (PVCs) of non-ischemic origin
Detailed description
The purpose of the study is to determine the effects of remifentanil conscious sedation in patients undergoing Electrophysiological (EP) studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent PVCs of non-ischemic origin. Remifentanil is an analgesic- synthetic opiate with an very short half life. It is rapidly broken down by enzymes in the blood and is ideally suited for continuous sedation. The effect is practically eliminated within 5 minutes after the intravenous sedation is stopped. You are being asked to participate in this study because you are already scheduled to undergo EP studies under the care of your cardiologist for the ablation of idiopathic ventricular tachycardia and/or persistent frequent PVCs of non-ischemic origin.
Interventions
DRUGRemifentanil
Patients with established PVC's , sedated with remifentanil IVPCA per study protocol
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to undergo EP studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent PVCs of non-ischemic origin * Patients between 18 and 65 * ASA 1-3
Exclusion criteria
* ASA 4 and 5 * Age 18 and 65
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inhibition of Idiopathic Ventricular Tachycardia | duration of the procedure or until the presence of PVC's was no longer required for the cardiologist to complete the ablation, average 2 hours | observation of the anesthetic effect on the inhibition of the ventricular tachycardia in patients undergoing radio-frequency ablation of idiopathic ventricular tachycardia. Patients were continuously monitored for presence of PVC's. Every 15 minutes patient's heart rhythm (EKG) was documented on the anesthetic record. Presence of PVC's of the same morphology was confirmed by the cardiologist performing the ablation. |
| PVC Suppression With Remifentanil Sedation | duration of the operative procedure, average 2 hours | 1 observed suppression of PVC's (PVC's of the same morphology are no longer observed during any 15 minute recording interval) 0 no suppression |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Remifentanil Remifentanil IV PCA | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Remifentanil |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 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 | 2 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Inhibition of Idiopathic Ventricular Tachycardia
observation of the anesthetic effect on the inhibition of the ventricular tachycardia in patients undergoing radio-frequency ablation of idiopathic ventricular tachycardia. Patients were continuously monitored for presence of PVC's. Every 15 minutes patient's heart rhythm (EKG) was documented on the anesthetic record. Presence of PVC's of the same morphology was confirmed by the cardiologist performing the ablation.
Time frame: duration of the procedure or until the presence of PVC's was no longer required for the cardiologist to complete the ablation, average 2 hours
Population: Study Data impacted by Storm Sandy in NYC and data lost for reporting
Primary
PVC Suppression With Remifentanil Sedation
1 observed suppression of PVC's (PVC's of the same morphology are no longer observed during any 15 minute recording interval) 0 no suppression
Time frame: duration of the operative procedure, average 2 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remifentanil IV PCA | PVC Suppression With Remifentanil Sedation | 2 participants with PVC suppression |
Comparison: null hypothesis:~Remifentanil IVPCA sedation in patients undergoing ablation of the idiopathic ventricular tachycardia does not cause suppression of PVC'sp-value: 0.050.15% CI: [0.65, 0.8]Fisher Exact