Dexmedetomidine and Adenosine: Therapeutic Use for SVT

NCT ID: NCT01495481

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-07-31

Brief Summary

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

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.

Conditions

Supraventricular Tachycardia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adenosine and Dexmedetomidine

Patients will receive adenosine and then dexmedetomidine for the termination of SVT

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Dexmedetomidine 2 mcg/kg, Intravenous push

Adenosine

Intervention Type: DRUG

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

Interventions

Dexmedetomidine

Dexmedetomidine 2 mcg/kg, Intravenous push

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Precedex

Eligibility 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Gaurav Arora

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gaurav Arora, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Childrens Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18931208 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21871284 (View on PubMed)

Other Identifiers

PRE-11-010

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PRO11070129

Identifier Type: -

Identifier Source: org_study_id