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IRCT20220809055645N2 IRCT 2023-04-03 Rasht University of Medical Sciences Effect of intravenous midazolam on radial artery spasm during performing coronary angiography Investigation the effect of intravenous midazolam on radial artery spasm during performing coronary angiography – Randomized double blinded placebo control clinical trial 2023-03-21 anticipated 56 Complete https://irct.ir/trial/69078 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random assignment of particioants into two study and control groups is done using permuted block randomization technique. For random allocation in this study, 4 blocks of 28 blocks are used. Using the specialized software from the Sealed envelope online software, chains of random numbers from 1 to 6 are generated until the desired sample size is reached. The date and time of randomization will be recorded. Concealment is done using the Sealed envelope method. To apply the concealment of the randomization process from the sealed non-transparent questionnaires that are numbered in order, the questionnaires of each person will be opened only after confirming the eligibility criteria for entering the study and signing the consent form by the person, Blinding description: In this study, in order to avoid bias in the study, the statistical expert, sequencing and distribution of patients into groups A and B is performed. Then, the type of intervention or using placebo for group A and B is done by someone outside the team of evaluators. Also, a colleague outside of the group is asked to put the original drug and the placebo, which have the same appearance and quality, in the required number in exactly the same, dark, and closed pockets; and name them as A and B based on the type of intervention or placebo and make it available to the plan executives. In this way, neither the study patients nor the moderators know about the intervention and placebo groups. 3 Radial Artery Spasm. Intervention 1: Intervention group: Immediately before the start of the procedure, they are injected with half a milligram of intravenous Midazolam (28) from Caspian Pharmaceutical Company. Intervention 2: Control group: Immediately before the start of the procedure, they are injected with half a milligram of normal saline. Yes - There is a plan to make this available What will be shared: All data except personal information (name, contact number, file number) can be published. When: After publishing the results To whom: Available to service providers such as doctors and nurses. Conditions: After obtaining permission from the project manager, the information will be usable. Where to obtain: Project manager How to obtain: By email to the project manager Comments: -
public Fatemeh Baharvand
Kooye Bayani
Rasht Iran (Islamic Republic of) 41939-55588 +98 13 3366 4282 dr.baharcardio@gmail.com Rasht University of Medical Sciences scientific Fatemeh Baharvand
Kooye Bayani
Rasht Iran (Islamic Republic of) 41939-55588 +98 13 3366 4282 dr.baharcardio@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients who undergo elective coronary angiography through right radial artery access. 18 years no limit Both Patient dissatisfaction Use of arterial access other than right radial artery (including femoral, brachial and left radial artery) Emergency patients Hemodynamic disorder Cardiogenic shock History of allergy to benzodiazepine History of severe respiratory complications Pregnancy and lactation History of AV fistula in the same hand Patients who are not candidates for radial angiography I70-I79 Diseases of arteries, arterioles and capillaries Prevention Placebo Intervention group: Immediately before the start of the procedure, they are injected with half a milligram of intravenous Midazolam (28) from Caspian Pharmaceutical Company. Control group: Immediately before the start of the procedure, they are injected with half a milligram of normal saline. Radial artery spasm. Timepoint: During and immediately after the completion of angiography. Method of measurement: The three components of the visual analogue scale are the measure of sympathetic stimulation (including SBP increase and HR increase during the procedure) and radial artery spasm. Duration of the procedure. Timepoint: Immediately after the completion of angiography. Method of measurement: The time interval from the start of vein finding to the exit of the angiography sheet. Duration of fluoroscopy. Timepoint: Immediately after the completion of angiography. Method of measurement: It is reported by the Siemens angiography device in the exam protocol section. Patient willingness to use radial access in the next possible angiography procedure. Timepoint: Immediately after the completion of angiography. Method of measurement: Ask the patient. Rasht University of Medical Sciences Approved 2023-03-01 Research Ethics Committees of Guilan University of Medical Sciences Namjoo Rasht Guilan Iran (Islamic Republic of)