Protocol summary
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Study aim
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Comparison of the efficacy of intra-arterial administration of labetalol versus intra-arterial nitroglycerin in reducing radial angiography- induced spasm and their effect on radial artery diameter
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Design
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Double blind, randomized clinical trial in patients undergoing radial angiography
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Settings and conduct
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This study is a randomized double-blind clinical trial conducted in Mazandaran Heart Center. Eight-member blocks were defined based on block-randomization. Patients respectively enrolled into the blocks and entered blindly into labetalol or nitroglycerin groups based on defined codes. An angiographic specialist prescribes the medication to the patients based on block-randomization and the investigator recorded the data without knowing the type of prescribed medication. Statistical analysts also was unaware of the interventionist groups.
First, the initial diameter of the radial artery was measured before medication administration. Then patients received intra-arterial nitroglycerin (150 micrograms) or intra-arterial labetalol (500 micrograms). Radial artery diameter was re-measured immediately after the medication administration, as well as at the end of the angiography. Any spasm and pain during the procedure was also recorded.
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Participants/Inclusion and exclusion criteria
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- Inclusion criteria:
All patients over 18 years old are candidates for radial angiography
- Exclusion criteria:
History of radial artery use in previous procedures, Peripheral artery disease and Raynauds, Ejection fraction less than 40%, Heart rate at rest less than 55 beats per minute, Systolic blood pressure less than 90 mmHg, History of liver disease, History of allergy to labetalol or nitroglycerin, Dissatisfaction of the patient to participate in the study
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Intervention groups
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1. Labetalol (500 microgram)
2. Nitroglycerin (150microgram)
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Main outcome variables
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1. Incidence of spasm
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151109024975N11
Registration date:
2019-01-06, 1397/10/16
Registration timing:
registered_while_recruiting
Last update:
2019-05-30, 1398/03/09
Update count:
1
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Registration date
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2019-01-06, 1397/10/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-10-23, 1397/08/01
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Expected recruitment end date
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2019-03-06, 1397/12/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Study of the effect of intra-arterial administration of nitroglycerin and labetalol on radial artery diameter and spasm in patients undergoing radial angiography
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Public title
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Comparison of labetalol and nitroglycerin in radial angiography-induced spasm
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-09-17, 1397/06/26
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Ethics committee reference number
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IR.MAZUMS.REC.1397.158
Health conditions studied
1
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Description of health condition studied
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Radial angiography-induced spasm
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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The occurrence of spasm following radial angiography
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Timepoint
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During angiography
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Method of measurement
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See the patient's angiogram during the procedure
Secondary outcomes
1
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Description
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Severity of pain caused by radial angiography
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Timepoint
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During angiography
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Method of measurement
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Patient observation and registration based on pain score
2
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Description
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Changing the diameter of the radial artery
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Timepoint
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During angiography
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Method of measurement
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Measuring arterial diameter with its own special software on the angiogram recorded on the computer
Intervention groups
1
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Description
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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) and the radial artery diameter will be re-measured immediately after the administration of the medication and at the end of the angiography. Any spasm (before medication administration, immediately after administration and at the end of procedure) and pain during the procedure will be recorded.
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Category
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Prevention
2
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Description
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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 (150microgram) and the radial artery diameter will be re-measured immediately after the administration of the medication and at the end of the angiography. Any spasm (before medication administration, immediately after administration and at the end of procedure)and pain during the procedure will be recorded.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Sari University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available