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Safety and Efficacy of Dexmedetomidine vs. Adenosine in the Acute Termination of Reentrant Supraventricular Tachycardia; a Randomized Control Study

PI: Constantinos Chrysostomou, MD

Funding: Industry

Purpose of Study

The purpose of this study is to evaluate the efficacy of dexmedetomidine in the acute termination of reentrant Supraventricular Tachycardia (SVT) in pediatric patients.

Study Design

Non-inferiority, randomized, controlled, study with double cross-over.

Background

In 2006 we discovered that dexmedetomidine, beyond its well known properties, possesses additional anti-arrhythmic properties. So far we have found that dexmedetomidine has the ability to prevent or terminate arrhythmias like atrial ectopic tachycardia (85% success), junctional ectopic tachycardia (75% success), atrial flutter and fibrillation (65%) and ventricular tachycardia (mostly prevention).

The most dramatic effect however was observed in the acute termination of reentrant SVT. Thus far 31 patients were treated for this purpose with successful cardioversion in 30 (97%). Initial results were published in the journal of Anesthesia & Analgesia and this publication has gained an enormous attention both in Europe and USA is now officially referenced in the:

a. “Part 10: Pediatric Basic and Advanced Life Support: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations”  Circulation. 2010 Oct 19;122(16 Suppl 2):S466-515  and

b.  “European Resuscitation Council Guidelines for Resuscitation 2010 Section 6. Paediatric life support”  Resuscitation 2010.Oct;81(10):1364-88.

placing dexmedetomidine among the other established anti-arrhythmic agents for the treatment of SVT and making thus a big breakthrough, even as a small Level of Evidence 4 study.  

Beyond however the idea of finding and introducing another anti-arrhythmic agent, what has gained more attention its dexmedetomidine’s side effect profile with lack of sinus pause or asystole after termination of SVT and therefore lack of the horrible feeling of impending “doom” or death which many patients experience. Overall when compared to adenosine, dexmedetomidine appears to be superior in the following areas:

Major Benefits
  1. Near 97% successful cardioversion to sinus rhythm which is higher than the multiple dose adenosine regimen of 65 -92 %.
  2. No significant bradycardia, sinus pause or any duration of asystole after cardioversion
  3. The duration of effect and the duration of sinus rhythm is significantly longer (1-3 hrs) than adenosine and thus beneficial in patients with multiple immediate SVT recurrences who traditionally may need multiple adenosine boluses/ hour.
  4. No pro-arrhythmic effect. Adenosine on the other hand, though the incidence is low, has been associated with both atrial and life threatening ventricular flutter and fibrillation. 
  5. In some patients dexmedetomidine is effective even when adenosine fails
Minor Benefits

            No immediate hypotension, no flushing, no bronchospasm, no chest pain, no nausea         

Primary End-Point of the study

The primary endpoint is acute termination of SVT

Secondary End-Points

a. Decreased incidence of sinus pause or any duration of asystole or of the feeling of “impending death” during cardioversion

b. Decreased incidence of secondary tachyarrhythmias