Supraventricular Tachycardia
Conditions
Keywords
Supraventricular Tachycardia, SVT, Reentrant Tachycardia, Dexmedetomidine, Adenosine
Brief summary
The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the acute termination of Supraventricular Tachycardia (SVT).
Detailed description
In 2006 the investigator found that dexmedetomidine, an alpha-2 adrenergic agonist with primarily sedative properties, possesses additional anti-arrhythmic properties. So far the investigator has found that dexmedetomidine has the ability to prevent or terminate arrhythmias like atrial ectopic tachycardia (85% success) and junctional ectopic tachycardia (75% success). The most dramatic effect however was observed in the acute termination of reentrant SVT with a success rate of \> 96%. More importantly we found that dexmedetomidine terminates SVT without causing any sinus pause or asystole (frequently seen with adenosine) and thus avoiding the feeling of impending doom. In this study adenosine is being compared head to head with dexmedetomidine in a cross over study, for both safety and efficacy when given for the termination of SVT in the electrophysiology (EP) lab. Additional EP parameters will be measured to elucidate the exact site of dexmedetomidine's mechanism of action.
Interventions
DRUGDexmedetomidine
Dexmedetomidine 2 mcg/kg, Intravenous push
DRUGAdenosine
Stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful
Sponsors
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Patients between the age of 5 - 30 years old, who are scheduled for cardiac electrophysiology study for evaluation of reentrant SVT
Exclusion criteria
* Severe Heart Failure * Presence of of any other antiarrhythmic medication within 24 hours of enrollment * Third degree heart block * Sick Sinus Syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Termination of SVT | Within 3 minutes | Number of participants with SVT Termination within 3 minutes of medication administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Sinus Pause >2.5 Sec After Termination of SVT | 1 minute | Evaluation of the number of participants with sinus pause \> 2.5 sec, after dexmedetomidine vs. adenosine induced SVT termination |
| Number of Participants With Tachyarrhythmias After Medication Administration | 10 minutes | Number of participants with tachyarrhythmias, including Ventricular (Ventricular Tachycardia & Fibrillation)and supraventricular (Atrial Flutter & Fibrillation) after dexmedetomidine vs. adenosine administration |
| Number of Participants With Hypotension by Non-invasive Cuff in First 10 Minutes After Medication Administration | 10 minutes | Blood pressure changes after dexmedetomidine vs. adenosine. Blood pressure measured by non-invasive cuff prior to medication administration, and then at 1 min, 3 min, 5 min after medication administration. Number of participants with a significant drop in blood pressure (mmHg) compared to baseline would be counted for hypotension. |
Countries
United States
Participant flow
Pre-assignment details
All 22 patients recruited received both adenosine and dexmedetomidine. Adenosine was administered first ,and then SVT was reinduced. Once SVT was reinduced, dexmedetomidine was administered. The washout period was not constant because it was dependent upon the reinduction of SVT, but it was generally less than 10 min.
Participants by arm
| Arm | Count |
|---|---|
| Adenosine and Dexmedetomidine Patients will receive both adenosine and dexmedetomidine for the termination of SVT. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Adenosine and Dexmedetomidine |
|---|---|
| Age, Categorical <=18 years | 22 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Termination of SVT
Number of participants with SVT Termination within 3 minutes of medication administration
Time frame: Within 3 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexmedetomidine | Termination of SVT | 16 participants |
| Adenosine | Termination of SVT | 21 participants |
Secondary
Number of Participants With Hypotension by Non-invasive Cuff in First 10 Minutes After Medication Administration
Blood pressure changes after dexmedetomidine vs. adenosine. Blood pressure measured by non-invasive cuff prior to medication administration, and then at 1 min, 3 min, 5 min after medication administration. Number of participants with a significant drop in blood pressure (mmHg) compared to baseline would be counted for hypotension.
Time frame: 10 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexmedetomidine | Number of Participants With Hypotension by Non-invasive Cuff in First 10 Minutes After Medication Administration | 1 participants |
| Adenosine | Number of Participants With Hypotension by Non-invasive Cuff in First 10 Minutes After Medication Administration | 0 participants |
Secondary
Number of Participants With Sinus Pause >2.5 Sec After Termination of SVT
Evaluation of the number of participants with sinus pause \> 2.5 sec, after dexmedetomidine vs. adenosine induced SVT termination
Time frame: 1 minute
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexmedetomidine | Number of Participants With Sinus Pause >2.5 Sec After Termination of SVT | 0 participants |
| Adenosine | Number of Participants With Sinus Pause >2.5 Sec After Termination of SVT | 16 participants |
Secondary
Number of Participants With Tachyarrhythmias After Medication Administration
Number of participants with tachyarrhythmias, including Ventricular (Ventricular Tachycardia & Fibrillation)and supraventricular (Atrial Flutter & Fibrillation) after dexmedetomidine vs. adenosine administration
Time frame: 10 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexmedetomidine | Number of Participants With Tachyarrhythmias After Medication Administration | 0 participants |
| Adenosine | Number of Participants With Tachyarrhythmias After Medication Administration | 0 participants |