Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05022290 |
| Other study ID # |
HE631158 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2020 |
| Est. completion date |
June 30, 2025 |
Study information
| Verified date |
March 2023 |
| Source |
Khon Kaen University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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).
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.
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.
