The short-term effect of lorazepam on the anxiety level of ST Elevation Myocardial Infarction (STEMI) patients candidate for Primary Percutaneous Coronary Intervention (PPCI)

Determination of the short-term effects of lorazepam in ST Elevation Myocardial Infarction patients candidate Primary Percutaneous Coronary Intervention.

A double blind clinical trial with 2 groups: intervention and control groups with 140 STEMI patients candidates for PPCI. Patients are randomly divided into two groups using sas software. In phase 2, in one group 70 people receive Lorazepam and the other group 70 people receive a placebo.

In this study, patients referred to Buali Sina Hospital in Qazvin with acute MI symptoms diagnosed with an ECG and troponin check, candidates for PPCI by a cardiologist, will be included. After giving the necessary explanations, informed consent is taken from the patients. patients will consume the contents of the medicine package 30 minutes before PPCI. On the first visit in the ward after PPCI, the anxiety level of the patients is assessed using the Hospital Anxiety and Depression Scale.

Inclusion criteria: 1. ST Elevation Myocardial Infarction 2. Primary Percutaneous Coronary Intervention candidate 3. From 18 to 80 years old Exclusion criteria: 1. Drug interactions: Alcohol; Barbiturates; Antipsychotics; Sedative/hypnotics; Anxiolytics; Opioids; Antidepressants; Narcotic analgesics; Sedative antihistamines; Anticonvulsants; Anesthetics 2. Contraindications for lorazepam prescription: Drug allergies; Acute angle closure glaucoma; Severe respiratory depression 3. Unconsciousness

Intervention group: Patients receive a Lorazepam tablet half an hour before Primary Percutaneous Coronary Intervention. Control group: patients receive a placebo half an hour before Primary Percutaneous Coronary Intervention.

Patients anxiety, procedure time, Primary and Secondary thrombolysis in myocardial infarction(TIMI) flow, Heart rate, QT interval

Sampling method will be done as available among patients. In the next step, the samples will be divided into two intervention and control groups in the form of blocked randomization. Blocking and sequencing of samples will be done with random allocation software. In order to conceal the random allocation process, the names of the groups are placed in envelopes, these envelopes are numbered from 1 to 140 and arranged in a box in; the researcher who performs the random allocation‌ wont be aware of the contents of the envelopes. The contents of the envelopes indicate the study groups (intervention or placebo) and after making sure that the sample enters the research and obtaining written consent, the first envelope is taken in order of number and according to the contents of the envelope and is placed in one of the Study groups are placed.

The patients, the researcher, the data collector and the outcome examiner, and the healthcare personnel will be unaware of the intervention and control groups. Lorazepam and placebo drug packages will be prepared and will be placed in the emergency room of the hospital without specifying its drug content. Medication packages are prepared by a separate pharmacist. On each package, a special code for the type of drug will be specified, and its content is specified in the study database.

All data is potentially shareable after unidentified individuals

Access period starts 6 months after the results are published

Academic and scientific researchers and Industries

Permission is granted to use the data for meta-analysis or to design other studies

Submit request via email dralipazoki@gmail.com a.pazoki@qums.ac.ir

If the applicant submits a request, if 6 months have passed since the publication of the article, it will be answered in less than 1 week.