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IRCT20151109024975N11 IRCT 2019-01-06 Mazandaran University of Medical Sciences Comparison of labetalol and nitroglycerin in radial angiography-induced spasm Study of the effect of intra-arterial administration of nitroglycerin and labetalol on radial artery diameter and spasm in patients undergoing radial angiography 2018-10-23 anticipated 64 Complete https://irct.ir/trial/35564 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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 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. 3 Radial angiography-induced spasm. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Gohar Eslami
Mazandaran University of Medical Sciences, Imam Square, Three Way Joybar, Beginning of Valiasr Highway
Sari Iran (Islamic Republic of) 48157-33971 +98 11 3354 3695 g.eslami@mazums.ac.ir Mazandaran University of Medical Sciences scientific Gohar Eslami
Mazandaran University of Medical Sciences, Imam Square, Three Way Joybar, Beginning of Valiasr Highway
Sari Iran (Islamic Republic of) 48157-33971 +98 11 3354 3695 g.eslami@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) All patients over 18 years old are candidates for radial angiography 18 years no limit Both 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 Prevention Prevention 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. 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. The occurrence of spasm following radial angiography. Timepoint: During angiography. Method of measurement: See the patient's angiogram during the procedure. Severity of pain caused by radial angiography. Timepoint: During angiography. Method of measurement: Patient observation and registration based on pain score. 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. Mazandaran University of Medical Sciences Approved 2018-09-17 Ethics committee of Mazandaran University of Medical Sciences Research Deputy of Mazandaran University of Medical Sciences, Moalem Square Sari Mazandaran Iran (Islamic Republic of)