1. Home
  2. Approved trials
  3. » فارسی

Comparison of efficiency and side effects of Adenosine versus Verapamil in treatment of Paroxysmal supraventricular tachycardia (psvt)

Protocol summary

Study aim
Comparison of efficiency and side effects of Adenosine versus Verapamil in treatment of Paroxysmal Supraventricular Tachycardia (PSVT)
Design
This study was designed as a single-blind clinical trial with a sample size of 180 patients with Paroxysmal Supraventricular Tachycardia (PSVT). Patients were randomly divided into control and intervention groupsWITH using sealed envelops receiving adenosine and verapamil using sealed envelopes.
Settings and conduct
Patients with Paroxysmal Supraventricular Tachycardia (PSVT) aged between 18 and 50 years were enrolled the study. exclusion critrea were History of Calcium blocker usage, history of Adenosine blocker agents usages, Brain hypo-perfusion, abnormal psychological state, pulmonary edema, pregnancy, history of Asthma, hypotension ,cardiogenic shock, heart failure, Wolff Parkinson White syndrome (WPW).
Participants/Inclusion and exclusion criteria
Patients with Paroxysmal Supraventricular Tachycardia (PSVT) aged between 18 and 50 years were enrolled the study. exclusion critrea were History of Calcium channel blocker usage, history of Adenosine blocker agents usages, Brain hypo-perfusion, abnormal psychological state, pulmonary edema, pregnancy, history of Asthma, hypotension ,cardiogenic shock, heart failure, Wolff Parkinson White syndrome (WPW).
Intervention groups
Intervention group: 6 mg adenosine intravenous push in patients with Paroxysmal Supraventricular Tachycardia (PSVT) control group: 2.5 mg verapamil in patients with psvt rhythm
Main outcome variables
Rhythm conversion to normal sinuous

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200202046343N1
Registration date: 2020-04-29, 1399/02/10
Registration timing: retrospective

Last update: 2020-04-29, 1399/02/10
Update count: 0
Registration date
2020-04-29, 1399/02/10
Registrant information
Name
setareh tavakkoli jebelli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3501 4008
Email address
tavakkolis961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-09, 1398/12/19
Expected recruitment end date
2020-04-23, 1399/02/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficiency and side effects of Adenosine versus Verapamil in treatment of Paroxysmal supraventricular tachycardia (psvt)
Public title
Adenosine versus Verapamil in Paroxysmal Supraventricular Tachycardia (PSVT)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Paroxysmal Supraventricular Tachycardia (PSVT) aged between 18 and 50 years.
Exclusion criteria:
History of Calcium blocker usage History of Adenosine blocker agents usages Brain hypo-perfusion Abnormal psychological state Pulmonary edema Pregnancy History of Asthma Hypotension Cardiogenic shock Heart failure Wolff Parkinson White syndrome (WPW)
Age
From 18 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization:Stratified Unit of randomization: Individual Tools used in randomization: Sealed envelops Allocation concealment: Sealed envelops
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants, data collectors, outcome assessors, and importance Data Safety and Monitoring Board and manuscript writers were blinded about the the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of mashhad University of Medical Sciences
Street address
Qoreishi Building, Daneshgah Street, Vice Chancellor for Research of Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9189833118
Approval date
2019-02-12, 1397/11/23
Ethics committee reference number
ir.mums.medical.rec.1398.496

Health conditions studied

1

Description of health condition studied
Paroxysmal supraventricular tachycardia (psvt)
ICD-10 code
147
ICD-10 code description
Abnormally rapid heartbeats with sudden onset and cessation

Primary outcomes

1

Description
Rhythm conversion to normal sinuous
Timepoint
After 5 minutes of drug administration
Method of measurement
Electrocardiography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 6 mg adenosine intravenous push
Category
Treatment - Drugs

2

Description
Control group: 5 mg verapamil intravenous push
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Setare Tavakkoli Jebeli
Street address
Emam Reza Hospital, Dr. Shariati Square
City
mashhad
Province
Razavi Khorasan
Postal code
9189833118
Phone
+98 51 3501 4008
Email
tavakkolis961@mums.ac.ir

2

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Setare Tavakkoli Jebeli
Street address
Ghaem Hospital, Dr. Shariati Square, beginning of Ahmadabad Avenue,
City
Mashhad
Province
Razavi Khorasan
Postal code
919875667
Phone
+98 51 3501 4009
Email
tavakkolis961@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Qoreishi Building, Daneshgah Street, Vice Chancellor for Research of Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9189833118
Phone
+98 51 3501 4008
Email
Tavakkolis961@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Setareh Tavakkoli Jebeli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Emam Reza Hospital, Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9189833118
Phone
+98 51 3501 4008
Email
Tavakkolis961@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Setareh Tavakkoli Jebeli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Emam Reza Hospital, Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9189833118
Phone
+98 51 3501 4008
Email
Tavakkolis961@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Setareh Tavakkoli jebelli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Emam Reza Hospital, Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9189833118
Phone
+98 51 3501 4008
Fax
Email
Tavakkolis961@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All potential data can be shared after unidentifiable participant.
When the data will become available and for how long
Data will be available 6 months after publication
To whom data/document is available
People working in academic institution
Under which criteria data/document could be used
Not applicable
From where data/document is obtainable
Setare Tavakkoli Jebeli Tavakkolis961@mums.ac.ir
What processes are involved for a request to access data/document
Not applicable
Comments
Loading...