Sammenligning af enkeltsprøjte- vs. dobbeltsprøjte-teknikker til administration af adenosin ved PSVT
Comparison of Single-syringe vs. Double-syringe Techniques for Adenosine Administration in Paroxysmal Supraventricular Tachycardia: A Randomized Controlled Trial
The purpose of the study is to compare the effectiveness of two different methods of administering adenosine for the treatment of stable paroxysmal supraventricular tachycardia (PSVT).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The American Heart Association 2015 guidelines recommend adenosine for non-hypotensive patients with regular narrow complex PSVT. 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 PSVT 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 compare the efficacy of SST and DST method for PSVT termination.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
-
Bandar Abbas, Iran
- Shahid Mohammadi Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age 18 to 80 years
- Presentation to the emergency department between May 2024 and December 2025 with narrow-QRS tachyarrhythmia
- Heart rate ≥150 beats/min
- No visible P wave or presence of retrograde P wave on ECG
- Not responsive to 2 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
- Acute asthma attack
- Heart transplant
- Systolic blood pressure < 90 mmHg
- Previous inclusion in the trial with a second episode of re-entry tachycardia less than 4 h after the first episode.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Enkeltsprøjteteknik (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 16 mL NS. A total of three doses could be provided to each patient |
|
Aktiv komparator: Dobbeltsprøjteteknik (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 16 mL NS. A total of three doses could be provided to each |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
First-dose Successful Termination of PSVT
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Administered Dose of Adenosine.
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PSVT management techniques
Plan for individuelle deltagerdata (IPD)
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