Dexmedetomidine Versus Adenosine: Electrophysiologic Effects and Therapeutic Use for Terminating Supraventricular Tachycardia - Full Text View

Purpose

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

Condition	Intervention
Supraventricular Tachycardia	Drug: Dexmedetomidine Drug: Adenosine

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Dexmedetomidine Versus Adenosine: Electrophysiologic Effects and Therapeutic Use for Terminating Supraventricular Tachycardia

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Adenosine Dexmedetomidine Dexmedetomidine hydrochloride

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Termination of SVT [ Time Frame: Within 3 minutes ] [ Designated as safety issue: No ]
SVT Termination within 3 minutes of dexmedetomidine administration

Secondary Outcome Measures:

Incidence and duration of sinus pause or asystole after termination of SVT [ Time Frame: 1 minute ] [ Designated as safety issue: Yes ]
Evaluation of the incidence and duration of asystole, after dexmedetomidine vs. adenosine induced SVT termination
Incidence of Tachyarrhythmias [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]
Incidence of Ventricular (Ventricular Tachycardia & Fibrillation)and supraventricular (Atrial Flutter & Fibrillation) arrhythmias after dexmedetomidine vs. adenosine administration
Hypotension and hypertension [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]
Blood pressure changes after dexmedetomidine vs. adenosine

Estimated Enrollment:	30
Study Start Date:	January 2012
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dexmedetomidine Patients will receive dexmedetomidine for the termination of SVT	Drug: Dexmedetomidine Dexmedetomidine 1 mcg/kg, Intravenous push Other Name: Precedex
Active Comparator: Adenosine Patients will receive Adenosine for the termination of SVT	Drug: 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

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

Ages Eligible for Study:	5 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495481

Contacts

Contact: Constantinos Chrysostomou, MD	412-692-7366	chrycx@chp.edu
Contact: Kelli E Shepler, bachelors	412-692-6061	kelli.shepler@upmc.edu

Locations

United States, Pennsylvania
Childrens Hospital of Pittsburgh of UPMC	Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Constantinos Chrysostomou, MD 412-692-7366 chrycx@chp.edu
Contact: Kelli Shepler, Bachelors 412-692-6061 kelli.shepler@upmc.edu

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator:

Constantinos Chrysostomou, MD

University of Pittsburgh, Childrens Hospital of Pittsburgh of UPMC

More Information

Publications:

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.

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.

Responsible Party:	Constantinos Chrysostomou, Assistant Professor of Critical Care Medicine & Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT01495481 History of Changes
Other Study ID Numbers:	PRO11070129, PRE-11-010
Study First Received:	December 15, 2011
Last Updated:	February 6, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Supraventricular Tachycardia
SVT
Reentrant Tachycardia
Dexmedetomidine
Adenosine

Additional relevant MeSH terms:

Tachycardia
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Adenosine
Dexmedetomidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013