Dexmedetomidine Versus Adenosine: Electrophysiologic Effects and Therapeutic Use for Terminating Supraventricular Tachycardia

Supraventricular Tachycardia Clinical Trial

Official title:

Dexmedetomidine Versus Adenosine: Electrophysiologic Effects and Therapeutic Use for Terminating Supraventricular Tachycardia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01495481
• Other study ID #: PRO11070129
• Secondary ID: PRE-11-010
• Status: Recruiting
• Phase: N/A
• First received: December 15, 2011
• Last updated: February 6, 2012
• Start date: January 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2012
• Source: University of Pittsburgh
• Contact: Constantinos Chrysostomou, MD
• Phone: 412-692-7366
• Email: chrycx[@]chp.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 30 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Supraventricular Tachycardia
• Tachycardia
• Tachycardia, Supraventricular

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine 1 mcg/kg, Intravenous push
• 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

Locations

Country	Name	City	State
United States	Childrens Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Termination of SVT	SVT Termination within 3 minutes of dexmedetomidine administration	Within 3 minutes	No
Secondary	Incidence and duration of sinus pause or asystole after termination of SVT	Evaluation of the incidence and duration of asystole, after dexmedetomidine vs. adenosine induced SVT termination	1 minute	Yes
Secondary	Incidence of Tachyarrhythmias	Incidence of Ventricular (Ventricular Tachycardia & Fibrillation)and supraventricular (Atrial Flutter & Fibrillation) arrhythmias after dexmedetomidine vs. adenosine administration	10 minutes	Yes
Secondary	Hypotension and hypertension	Blood pressure changes after dexmedetomidine vs. adenosine	10 minutes	Yes