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Dexmedetomidine and Adenosine: Therapeutic Use for SVT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gaurav Arora, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01495481
First received: December 15, 2011
Last updated: February 7, 2017
Last verified: February 2017
  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: Intervention Model: Single Group Assignment
Masking: None (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 Gaurav Arora, University of Pittsburgh:

Primary Outcome Measures:
  • Termination of SVT [ Time Frame: Within 3 minutes ]
    Number of participants with SVT Termination within 3 minutes of medication administration


Secondary Outcome Measures:
  • Number of Participants With Sinus Pause >2.5 Sec After Termination of SVT [ Time Frame: 1 minute ]
    Evaluation of the number of participants with sinus pause > 2.5 sec, after dexmedetomidine vs. adenosine induced SVT termination

  • Number of Participants With Tachyarrhythmias After Medication Administration [ Time Frame: 10 minutes ]
    Number of participants with tachyarrhythmias, including Ventricular (Ventricular Tachycardia & Fibrillation)and supraventricular (Atrial Flutter & Fibrillation) after dexmedetomidine vs. adenosine administration

  • Number of Participants With Hypotension by Non-invasive Cuff in First 10 Minutes After Medication Administration [ Time Frame: 10 minutes ]
    Blood pressure changes after dexmedetomidine vs. adenosine. Blood pressure measured by non-invasive cuff prior to medication administration, and then at 1 min, 3 min, 5 min after medication administration. Number of participants with a significant drop in blood pressure (mmHg) compared to baseline would be counted for hypotension.


Enrollment: 22
Study Start Date: January 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adenosine and Dexmedetomidine
Patients will receive adenosine and then dexmedetomidine for the termination of SVT
Drug: Dexmedetomidine
Dexmedetomidine 2 mcg/kg, Intravenous push
Other Name: Precedex
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   (Child, Adult)
Sexes Eligible for Study:   All
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

Locations
United States, Pennsylvania
Childrens Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Gaurav Arora, MD University of Pittsburgh
  More Information

Publications:
Responsible Party: Gaurav Arora, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01495481     History of Changes
Other Study ID Numbers: PRO11070129
PRE-11-010 ( Other Grant/Funding Number: Hospira, Inc )
Study First Received: December 15, 2011
Results First Received: February 18, 2016
Last Updated: February 7, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gaurav Arora, 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
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents

ClinicalTrials.gov processed this record on August 21, 2017