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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
- 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
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.
- Conditions
- Supraventricular Tachycardia
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. 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.
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)
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.
- First posted26 Aug 2021
- Study start1 Oct 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Praew Kotruchin, Khon Kaen University
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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Double-syringe vs Single-syringe Technique of Adenosine Administration for Termination of Regular-narrow Complex Tachycardia: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05022290
- Acronym / sponsor ID
- HE631158
- Conditions
- Supraventricular Tachycardia
- Keywords
- adenosine, tachycardia, single bolus, emergency, Asian
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single-syringe technique | Experimental | Procedure: Single-syringe diluted with normal saline techniquePatients 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. |
| Double-synring technique | Active comparator | Procedure: Single-syringe diluted with normal saline techniquePatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Acute asthmatic attack
- Pregnant or tendency to be pregnant
- Acute heart failure
- Acute chest pain
- Alteration of consciousness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-syringe diluted with normal saline techniqueAdenosine is mixed with normal saline up to 20 ml in a single syringe before administering to the patient by the IV bolus method. | Procedure or surgery | Double-synring technique, Single-syringe technique |
Primary outcome
Termination of supraventricular tachycardia (SVT)
Time frame: 1 minute after complete administration of adenosine intravenously
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 secondary outcome
Total dose of adenosine used for termination of supraventricular tachycardia
Time frame: 10 minutes after diagnosis of supraventricular tachycardia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: Undecided. Will decide after a complete enrollment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.