Dexmedetomidine and Adenosine: Therapeutic Use for SVT
Primary Purpose
Supraventricular Tachycardia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Adenosine
Sponsored by
About this trial
This is an interventional treatment trial for Supraventricular Tachycardia focused on measuring Supraventricular Tachycardia, SVT, Reentrant Tachycardia, Dexmedetomidine, Adenosine
Eligibility Criteria
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
Sites / Locations
- Childrens Hospital of Pittsburgh of UPMC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adenosine and Dexmedetomidine
Arm Description
Patients will receive adenosine and then dexmedetomidine for the termination of SVT
Outcomes
Primary Outcome Measures
Termination of SVT
Number of participants with SVT Termination within 3 minutes of medication administration
Secondary Outcome Measures
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
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
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.
Full Information
NCT ID
NCT01495481
First Posted
December 15, 2011
Last Updated
February 7, 2017
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT01495481
Brief Title
Dexmedetomidine and Adenosine: Therapeutic Use for SVT
Official Title
Dexmedetomidine Versus Adenosine: Electrophysiologic Effects and Therapeutic Use for Terminating Supraventricular Tachycardia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supraventricular Tachycardia
Keywords
Supraventricular Tachycardia, SVT, Reentrant Tachycardia, Dexmedetomidine, Adenosine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adenosine and Dexmedetomidine
Arm Type
Experimental
Arm Description
Patients will receive adenosine and then dexmedetomidine for the termination of SVT
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Dexmedetomidine 2 mcg/kg, Intravenous push
Intervention Type
Drug
Intervention Name(s)
Adenosine
Intervention Description
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
Primary Outcome Measure Information:
Title
Termination of SVT
Description
Number of participants with SVT Termination within 3 minutes of medication administration
Time Frame
Within 3 minutes
Secondary Outcome Measure Information:
Title
Number of Participants With Sinus Pause >2.5 Sec After Termination of SVT
Description
Evaluation of the number of participants with sinus pause > 2.5 sec, after dexmedetomidine vs. adenosine induced SVT termination
Time Frame
1 minute
Title
Number of Participants With Tachyarrhythmias After Medication Administration
Description
Number of participants with tachyarrhythmias, including Ventricular (Ventricular Tachycardia & Fibrillation)and supraventricular (Atrial Flutter & Fibrillation) after dexmedetomidine vs. adenosine administration
Time Frame
10 minutes
Title
Number of Participants With Hypotension by Non-invasive Cuff in First 10 Minutes After Medication Administration
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaurav Arora, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18931208
Citation
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.
Results Reference
background
PubMed Identifier
21871284
Citation
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.
Results Reference
background
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Dexmedetomidine and Adenosine: Therapeutic Use for SVT
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