Study of the effect of intra-arterial administration of nitroglycerin and labetalol-nitroglycerin combination on radial artery diameter and spasm in patients undergoing radial angiography
Comparison of the efficacy of intra-arterial administration of labetalol-nitroglycerin combination versus intra-arterial nitroglycerin in reducing radial angiography- induced spasm and their effect on radial artery diameter
Design
Double blind, randomized clinical trial in patients undergoing radial angiography
Settings and conduct
Double blind, randomized clinical trial in Mazandaran heart center
Participants/Inclusion and exclusion criteria
All patients over 18 years old are candidates for radial angiography
Intervention groups
1. Labetalol (500 microgram)+ Nitroglycerin (200 microgram) group
2. Nitroglycerin (200 microgram) group
Main outcome variables
1. Incidence of spasm
2. Change the diameter of the radial artery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151109024975N11
Registration date:2019-01-06, 1397/10/16
Registration timing:registered_while_recruiting
Last update:2019-01-06, 1397/10/16
Update count:1
Registration date
2019-01-06, 1397/10/16
Registrant information
Name
Gohar Eslami
Name of organization / entity
Mazandaran University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3695
Email address
g.eslami@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-28, 1397/09/07
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of intra-arterial administration of nitroglycerin and labetalol-nitroglycerin combination on radial artery diameter and spasm in patients undergoing radial angiography
Public title
Comparison of labetalol and labetalol-nitroglycerin combination in radial angiography-induced spasm
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients over 18 years old are candidates for radial angiography
Exclusion criteria:
History of using radial artery during previous procedures
Peripheral vascular diseases
Raynaud syndrome
Ejection fraction <40%
Heart rate at rest less than 55
Systolic blood pressure less than 90 mmHg
History of liver disease
History of labetalol or nitroglycerin allergy
Dissatisfaction patient to participate in the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, samples will be assigned to two groups by block randomization method. Eight-member blocks were created using random allocation software with sequential codes. Then, samples with inclusion criteria will randomly enter to the two groups according the codes.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, an angiographic specialist prescribes the drug to the patients based on block-randomization and the investigator records the data without knowing the type of prescribed drug. Statistical analysts will also be unaware of the interventionist groups.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی مازندران
Street address
Research Deputy of Mazandaran University of Medical Sciencesm Moalem Square
City
Sari
Province
Mazandaran
Postal code
48175-861
Approval date
2018-09-17, 1397/06/26
Ethics committee reference number
IR.MAZUMS.REC.1397.158
Health conditions studied
1
Description of health condition studied
Radial angiography-induced spasm
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Changing the diameter of the radial artery
Timepoint
During angiography
Method of measurement
Measuring arterial diameter with its own special software on the angiogram recorded on the computer
2
Description
The occurrence of spasm following radial angiography
Timepoint
During angiography
Method of measurement
See the patient's angiogram during the procedure
Secondary outcomes
1
Description
Severity of pain caused by radial angiography
Timepoint
During angiography
Method of measurement
Patient observation and registration based on pain score
Intervention groups
1
Description
Intervention group: Initially, the diameter of the radial artery will be measured prior to administration of the drug. Then, the patients will receive intra-arterial labetalol (500 microgram) + nitroglycerin (200 microgram) and the radial artery diameter will be re-measured immediately after the administration of the medication and at the end of the angiography. Any spasticity and pain during the procedure will be recorded.
Category
Prevention
2
Description
Intervention group: Initially, the diameter of the radial artery will be measured prior to administration of the drug. Then, the patients will receive intra-arterial nitroglycerin (200 microgram) and the radial artery diameter will be re-measured immediately after the administration of the medication and at the end of the angiography. Any spasticity and pain during the procedure will be recorded.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh-zahra hospital Mazandaran University of Medical Scienses
Full name of responsible person
گوهر اسلامی
Street address
Artesh Blvd - Center of the heart of Mazandaran
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3331 4086
Fax
+98 11 3332 4002
Email
g.eslami@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Moalem Square, Research Deputy of MazandaranUniversity of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3325 7230
Fax
+98 11 3326 1244
Email
g.eslami@mazums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Mazandaran University of Medical Sciences
Full name of responsible person
Gohar Eslami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Mazandaran University of Medical Sciences, Imam Square, Three Way Joybar, Beginning of Valiasr Highway
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3354 3695
Fax
+98 11 3354 3695
Email
g.eslami@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Gohar Eslami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Mazandaran University of Medical Sciences, Imam Square, Three Way Joybar, Beginning of Valiasr Highway
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3354 3695
Fax
+98 11 3354 3695
Email
g.eslami@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Gohar Eslami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
آدرس خیابان Mazandaran University of Medical Sciences, Imam Square, Three Way Joybar, Beginning of Valiasr Highway
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3354 3695
Fax
+98 11 3335 2725
Email
g.eslami@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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