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Supraventricular TachycardiaNCT05022290

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

A study testing Single-syringe diluted with normal saline technique in people with Supraventricular Tachycardia, run by Khon Kaen University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Supraventricular Tachycardia
What is being tested?
Single-syringe diluted with normal saline technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteThailand
Study dates
1 Oct 2020to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Thailand1 site, 1 recruiting
  • Department of Emergency medicine

    Khon Kaen, Muang, 40002

    Jiranan Thedmee, BSc, +66366869, jirathe@kku.ac.th

    Siwaporn Kwansanei, BSc, +66366869, ksiwap@kku.ac.th

    Recruiting

Other trials in Thailand

About this study

Official title: Comparison of Double-syringe vs Single-syringe Technique of Adenosine Administration for Termination of Regular-narrow Complex Tachycardia: A Randomized, Controlled Trial

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.

Read the detailed description

Supraventricular tachycardia (SVT) is the most common tachyarrhythmias in young adults, children, and infants. The most common type in adults is the atrioventricular nodal reentrant tachycardia (AVNRT) and the incidence is 35 per 10,000 person-years or 2.29 per 1000 persons.

The treatment approach of SVT is based on hemodynamical stability. The synchronized cardioversion is recommended for hemodynamically unstable patients, on the other hand, the vagal maneuvers and medications are considered for patients with stable hemodynamic.

To date, the 2019 ESC guideline for the management of supraventricular tachycardia stated that adenosine is still the first medication for acute therapy in patients with SVT if the vagal maneuver fails or is contraindicated. A systematic review in 2021 showed that adenosine is equally efficacious for treating SVT, but it is safer than intravenous calcium channel blockers due to a shorter half-life.

Few studies reported that the effectiveness of conventional vagal maneuvers, namely, carotid sinus massage in SVT termination was around 19 to 54% when properly done. The enhanced method of vagal maneuver or named the modified syringe technique was performed by blowing into a 10 mL syringe to move the plunger, the success conversion rate of SVT was a little better than the convention technique (43% vs 17%). Therefore, adenosine is still crucial in the acute therapy of SVT in an emergency setting.

Adenosine has been discovered since 1929 and used in the acute treatment of arrhythmias. It was used as a therapeutic diagnosis in patients with regular narrow QRS complex tachyarrhythmias and it is also helpful in treating some type of regular wide QRS complex tachyarrhythmias (differentiate between SVT with aberrancy/bundle branch block and ventricular tachycardia).

Adenosine, an endogenous purine nucleoside, is the first drug of choice to terminate SVT. The pharmacological response of adenosine is mediated through cardiac adenosine type 1 (A1) receptors and has a dose-response relationship. It prolongs atrioventricular (AV) conduction and results in transient AV block that is responsible for tachyarrhythmia termination. The dosages for the peripheral intravascular (IV) route are 6 mg and follow by 12 mg if the first dose is failed.2 To achieve rhythm conversion, the injection should be performed as a rapid bolus with immediate saline flush through large veins (e.g. antecubital) in 1-2 seconds, because adenosine is rapidly metabolized by enzymatic deamination to inactive inosine within seconds, and achieve end-organ effects within 20-30 seconds.2 This conventional method of adenosine administration is well-known as the double syringe technique (DST). The repeat dose is safe when administered at least 1 minute after the first dose. The success rate of adenosine in terminating SVT was greater than 90% approximately.

The potential side effects of adenosine are transient AV block, flushing, chest pain, or dyspnea, AF can be initiated or worsened in case of preexcitation existing, premature ventricular tachycardias (PVCs)/ventricular tachycardia (VT), bronchospasm (rare), or coronary steal.5 In addition, Adenosine should be excluded or used with caution in patients with these conditions (e.g. AV block greater than first degree or sinoatrial (SA) node dysfunction, reactive airway disease, concomitant use of verapamil or digoxin, and Wolff-Parkinson-White (WPW) syndrome).5

The DST requires a two-way stopcock which may not stock in some workplaces e.g. emergency medical services (EMS) and need the nursing staff to coordinate their actions administering the drug and flush simultaneously. In the real world, small hospitals had a transient shortage of medical equipment supply e.g. syringes. The convenient method which combined adenosine and 15 mL of normal saline in one syringe was firstly proposed in the non-blind, randomized prospective study between 1999 to 2001 and published the full original article in the Korean language since 2003 by Choi SC et al. This trial demonstrated the success rate of the convenient method was higher than the standard method (85.7 vs 80%), but it's not statistically significant, in addition, the average of total administering doses, and the complication of the convenient and standard method was not statistically different.

Nearly two decades later, Marc McDowell et al. conducted a single-center, prospective, observational study with setting a 20% non-inferiority margin demonstrated that the successful conversion of SVT in the first dose (73.1 vs 40.7%) and up to three doses (100 vs 70.4%) in the single syringe technique (SST) and DST respectively. And they didn't found any serious adverse effects e.g. dyspnea, bradycardia, or asystole. Unfortunately, superiority testing was not performed due to the limiting sample size.

Therefore, we hypothesized that the SST is non-inferior to the DST for terminating stable SVT, by comparison, a rate of successful conversion of SVT at the first 6 mg-dose of adenosine and the total average dosage of adenosine administered. And we also aimed to compare the rate of side effects between both techniques of intravenous adenosine in those diagnosed with stable SVT.

Being tested
Single-syringe diluted with normal saline technique
Keywords
adenosine, tachycardia, single bolus, emergency, Asian
Medical subject headings
Tachycardia, Supraventricular, Tachycardia, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single-syringe diluted with normal saline techniqueProcedure or surgery

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

Study groups in NCT05022290
Study groupRoleWhat they receive
Single-syringe techniqueExperimentalPatients 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.
Receives: Procedure: Single-syringe diluted with normal saline technique
Double-synring techniqueActive comparatorPatients 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.
Receives: Procedure: Single-syringe diluted with normal saline technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 minute after complete administration of adenosine intravenously

Secondary outcomes (1)
  1. Total dose of adenosine used for termination of supraventricular tachycardia

    Calculated the total dose of adenosine administration of each patient (milligram)

    Measured: 10 minutes after diagnosis of supraventricular tachycardia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2021
  2. Study start1 Oct 2020
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05022290
Sponsor's protocol ID
HE631158
Status last verified
Mar 2023
First submitted
21 Aug 2021
Last updated
17 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Will decide after a complete enrollment.

Questions about this trial

What is this clinical trial studying?

A study testing Single-syringe diluted with normal saline technique in people with Supraventricular Tachycardia, run by Khon Kaen University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Termination of supraventricular tachycardia (SVT) (time frame: 1 minute after complete administration of adenosine intravenously). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.

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