Investigation the effect of intravenous midazolam on radial artery spasm during performing coronary angiography – Randomized double blinded placebo control clinical trial

Investigating the effect of intravenous Midazolam on radial artery spasm during coronary angiography, a double-blind randomized clinical trial with a placebo control.

Clinical trial with control group, single center, with parallel groups, double-blind, randomized, phase 3 on 56 patients that candidate for elective coronary angiography. Random assignment of participants into two study and control groups is done using permuted block randomization technique.

This double-blind study will be conducted in Heshmat Hospital in Rasht. Subjects and evaluators are blinded.

Inclusion criteria: patients who undergo elective coronary angiography through right radial artery access. Exclusion criteria: The exclusion criteria include the patients who don’t confirm the informed constant and the use of arterial accesses other than the radial artery (including femoral, brachial, and left radial arteries). Also, patients with emergency condition, hemodynamic disorder, cardiogenic shock, history of allergy to any benzodiazepine, and history of severe respiratory problems were excluded from the study. Other exclusion criteria include pregnancy and lactating, history of AV fistula in the same hand, and patients who are not a good candidate to perform radial angiography.

56 patients over 18 years of age who were candidates for coronary angiography electively during 2021-2022 will be included in the study. Half of the patients are injected with half a milligram of intravenous Midazolam (28) immediately before the start of the procedure.

The primary outcome includes the reduction of radial artery spasm, which is divided into three components of the visual analogue scale, the measure of sympathetic stimulation (including increased SBP and increased HR during the procedure) and radial artery spasm.

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.

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.

All data except personal information (name, contact number, file number) can be published.

After publishing the results

Available to service providers such as doctors and nurses.

After obtaining permission from the project manager, the information will be usable.

Project manager

By email to the project manager

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