Double-syringe vs Single-syringe Technique of Adenosine for Termination of Regular Narrow Complex Tachycardia

NCT05022290 | Unknown

• 1 other identifier: HE631158
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Adenosine has been discovered since 1929 and used in the acute treatment of arrhythmias. It uses as a therapeutic diagnosis in patients with regular narrow QRS complex tachyarrhythmias. The conventional method of adenosine administration is the double syringe technique (DST). However, it consumes a lot of resources including two syringes, a stopcock, an extension tube, and needs 2 nurses to administer. An observational study found that a single syringe technique (adenosine diluted with normal saline up to 20 ml) was as effective as a double syringe technique. However, there is no randomized control trial for proving its efficacy.

Conditions

Supraventricular Tachycardia

Keywords

adenosine; tachycardia; single bolus; emergency; Asian

Outcome Measures

Primary Outcomes (1)

• Termination of supraventricular tachycardia (SVT)

  The outcome is achieved when doctor in charge determine that the supraventricular tachycardia is terminated by administration of adenosine with the EKG after treatment showing sinus rhythm.

  1 minute after complete administration of adenosine intravenously

Secondary Outcomes (1)

• Total dose of adenosine used for termination of supraventricular tachycardia

  10 minutes after diagnosis of supraventricular tachycardia

Study Arms (2)

Single-syringe technique

EXPERIMENTAL

Patients in this arm will receive adenosine in a single syringe, diluted with normal saline up to 20 ml. The dosage of adenosine is according to the recommendation of ACLS guidelines, which recommended 6 mg as the first dose and 12 mg as the subsequent dose if SVT can not be terminated by the first dose.

Procedure: Single-syringe diluted with normal saline technique

Double-synring technique

ACTIVE COMPARATOR

Patients in this arm will receive adenosine using a double syringe, the first syringe contains only adenosine and the second syringe contains only normal saline 20 ml. Both syringes are connected to each other, and to the patient's IV portal with a stopcock. The administration must be done by two nurses one after another, adenosine syringe is injected first, then follow by normal saline. The dosage of adenosine is according to the recommendation of ACLS guidelines, which recommended 6 mg as the first dose and 12 mg as the subsequent dose if SVT can not be terminated by the first dose.

Procedure: Single-syringe diluted with normal saline technique

Interventions

Single-syringe diluted with normal saline technique PROCEDURE

Adenosine is mixed with normal saline up to 20 ml in a single syringe before administering to the patient by the IV bolus method.

Double-synring technique; Single-syringe technique

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-80 years old
• EKG shows regular rhythm, narrow QRS complex tachyarrhythmias (QRS complex \<0.12 msec, and rate \>150 beats per minute; bpm)
• Pulse can be palpated
• The tachycardia is not terminated by a vagal maneuver.

You may not qualify if:

• Acute asthmatic attack
• Pregnant or tendency to be pregnant
• Acute heart failure
• Acute chest pain
• Alteration of consciousness
• Hypotension
• Presenting of signs of hypoperfusion

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Department of Emergency medicine

Khon Kaen, Muang, 40002, Thailand

RECRUITING

MeSH Terms

Conditions

Tachycardia, Supraventricular; Tachycardia; Emergencies

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: There will be an opaque fabric shade that covered the participant's right upper arm during treatment that does not allow them to see the methods of drug administration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: In a randomized controlled trial, participants will be allocated into 2 groups. Each group receives adenosine with the same dosage but different methods of administration.

Study Record Dates

• First Submitted: August 21, 2021
• First Posted: August 26, 2021
• Study Start: October 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

TH (1)