- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07554170
Comparison of Single-syringe vs. Double-syringe Techniques for Adenosine Administration in PSVT
Comparison of Single-syringe vs. Double-syringe Techniques for Adenosine Administration in Supraventricular Tachycardia: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The American Heart Association 2015 guidelines recommend adenosine for non-hypotensive patients with regular narrow complex SVT. Adenosine is usually given as a rapid intravenous bolus of 6mg over 1-2 seconds, followed by a 20ml saline flush. If the first dose does not result in the termination of SVT to normal sinus rhythm (NSR) within 1-2 minutes, a repeat dose of 12mg can be given, and the dose may be repeated one more time, if necessary, for a total of three doses.
The double-syringe technique (DST) is the standard method for administering adenosine. However, recent studies suggest that the single-syringe technique (SST) may be simpler and potentially beneficial. This technique injects adenosine and saline simultaneously at the same time instead of two separate injections. The study aims to determine if the SST method is non-inferior to the DST method.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Bandar Abbas, Iran
- Shahid Mohammadi Hospital
-
-
Hormozgan
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Bandar Abbas, Hormozgan, Iran
- Shahid Mohammadi Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 to 80 years
- Presentation to the emergency department with narrow-QRS tachyarrhythmia
- Heart rate ≥150 beats/min
- No visible P wave or presence of retrograde P wave on ECG
- Not responsive to Valsalva maneuvers lasting 15 to 30 seconds
- Requiring adenosine administration
Exclusion Criteria:
- Wide-QRS tachycardia or irregular R-R interval on ECG
- Known allergy or contraindication to adenosine
- Recent ingestion of dipyridamole, carbamazepine, or theophylline
- Caffeine ingestion within the previous 2 hours
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single-syringe technique (SST)
|
Simplified method, containing both 6 mg of adenosine and 18 mL NS.
If SVT termination failed: Second dose of adenosine with SS containing both 12 mg of adenosine and 18 mL NS.
A total of three doses could be provided to each patient
|
|
Active Comparator: Double-syringe technique (DST)
|
One Syringe containing 6 mg of adenosine + one syringe containing 20 mL NS aided with a stopcock.
If SVT termination failed: Second dose of adenosine (12 mg) + one syringe containing 20 mL NS.
A total of three doses could be provided to each
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First-dose successful termination of PSVT
Time Frame: Within 2 minutes after administration of the first dose of adenosine.
|
Proportion of participants with conversion from paroxysmal supraventricular tachycardia to sinus rhythm after the first dose of adenosine.
|
Within 2 minutes after administration of the first dose of adenosine.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total administered dose of adenosine.
Time Frame: From administration of the first dose until successful termination of PSVT or up to 10 minutes, whichever occurs first.
|
Total cumulative dose of adenosine (mg) administered to achieve termination of PSVT.
|
From administration of the first dose until successful termination of PSVT or up to 10 minutes, whichever occurs first.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SVT management techniques
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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