Clinical trial NCT01495481: Dexmedetomidine and Adenosine: Therapeutic Use for SVT
Official title: Dexmedetomidine Versus Adenosine: Electrophysiologic Effects and Therapeutic Use for Terminating Supraventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supraventricular Tachycardia
Keywords: Supraventricular Tachycardia
SVT
Reentrant Tachycardia
Dexmedetomidine
Adenosine
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2011-12-20
Enrollment: 22
Sex: ALL
Minimum age (years): 5
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Termination of SVT
timeFrame: Within 3 minutes
Secondary outcomes:
measure: Number of Participants With Sinus Pause >2.5 Sec After Termination of SVT
timeFrame: 1 minute
measure: Number of Participants With Tachyarrhythmias After Medication Administration
timeFrame: 10 minutes
measure: Number of Participants With Hypotension by Non-invasive Cuff in First 10 Minutes After Medication Administration
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Childrens Hospital of Pittsburgh of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Gaurav Arora, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.