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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Constantinos Chrysostomou, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01495481
First received: December 15, 2011
Last updated: February 6, 2012
Last verified: February 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Dexmedetomidine
Adenosine
Therapeutic Uses
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on September 18, 2014