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| ID | Type | Description | Link |
|---|---|---|---|
| PRE-11-010 | Other Grant/Funding Number | Hospira, Inc |
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The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the acute termination of Supraventricular Tachycardia (SVT).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adenosine and Dexmedetomidine | Experimental | Patients will receive adenosine and then dexmedetomidine for the termination of SVT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine 2 mcg/kg, Intravenous push |
|
| Measure | Description | Time Frame |
|---|---|---|
| Termination of SVT | Number of participants with SVT Termination within 3 minutes of medication administration | Within 3 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 minute |
| Number of Participants With Tachyarrhythmias After Medication Administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gaurav Arora, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18931208 | Background | Chrysostomou C, Beerman L, Shiderly D, Berry D, Morell VO, Munoz R. Dexmedetomidine: a novel drug for the treatment of atrial and junctional tachyarrhythmias during the perioperative period for congenital cardiac surgery: a preliminary study. Anesth Analg. 2008 Nov;107(5):1514-22. doi: 10.1213/ane.0b013e318186499c. | |
| 21871284 | Background |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adenosine and Dexmedetomidine | Patients will receive adenosine for termination of SVT, and then dexmedetomidine for the termination of supraventricular tachycardia (SVT) and comparison will be made for efficacy and safety. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adenosine |
| |||||||||||||
| Washout |
| |||||||||||||
| Dexmedetomidine |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adenosine and Dexmedetomidine | Patients will receive both adenosine and dexmedetomidine for the termination of SVT. |
| 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 | Termination of SVT | Number of participants with SVT Termination within 3 minutes of medication administration | Posted | Number | participants | Within 3 minutes |
|
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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 | Dexmedetomidine | Patients will receive dexmedetomidine for the termination of SVT Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gaurav Arora | University of Pittsburgh | 412-692-6054 | gaurav.arora@chp.edu |
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| ID | Term |
|---|---|
| D013617 | Tachycardia, Supraventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000241 | Adenosine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Adenosine | Drug | 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 |
|
Number of participants with tachyarrhythmias, including Ventricular (Ventricular Tachycardia & Fibrillation)and supraventricular (Atrial Flutter & Fibrillation) after dexmedetomidine vs. adenosine administration |
| 10 minutes |
| 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. | 10 minutes |
| Chrysostomou C, Sanchez-de-Toledo J, Wearden P, Jooste EH, Lichtenstein SE, Callahan PM, Suresh T, O'Malley E, Shiderly D, Haney J, Yoshida M, Orr R, Munoz R, Morell VO. Perioperative use of dexmedetomidine is associated with decreased incidence of ventricular and supraventricular tachyarrhythmias after congenital cardiac operations. Ann Thorac Surg. 2011 Sep;92(3):964-72; discussion 972. doi: 10.1016/j.athoracsur.2011.04.099. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| 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 | Posted | Number | participants | 1 minute |
|
|
|
| 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 | Posted | Number | participants | 10 minutes |
|
|
|
| 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. | Posted | Number | participants | 10 minutes |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Adenosine | Patients will receive Adenosine for the termination of SVT Adenosine: 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 | 0 | 22 | 0 | 22 |
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| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011684 |
| Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |