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IRCT20201102049232N3 IRCT 2023-01-10 Qazvin University of Medical Sciences The effect of Lorazepam on the anxiety of heart attack patients The short-term effect of lorazepam on the anxiety level of ST Elevation Myocardial Infarction (STEMI) patients candidate for Primary Percutaneous Coronary Intervention (PPCI) 2023-01-21 anticipated 140 Complete https://irct.ir/trial/67440 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Condition 1: STEMI. Condition 2: Anxiety. Intervention 1: Intervention group: Patients in this group receive a single dose of 1 mg/dl lorazepam from Kimidaro pharmaceutical company half an hour before Primary Percutaneous Coronary Intervention (PPCI) and after the PPCI their anxiety levels will be assessed. Intervention 2: Control group: They are the group that receives a single dose of placebo containing microcrystalline cellulose and magnesium acetate from Alborz Daru company half an hour before primary Percutaneous Coronary Intervention (PPCI) and after the PPCI their anxiety levels will be assessed. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 6 months after the results are published To whom: Academic and scientific researchers and Industries Conditions: Permission is granted to use the data for meta-analysis or to design other studies Where to obtain: Submit request via email dralipazoki@gmail.com a.pazoki@qums.ac.ir How to obtain: 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. Comments:
public Ali Pazoki
Secretariat, Bouali Hospital, Bouali Street
Qazvin Iran (Islamic Republic of) 3413786165 +98 28 3332 6034 a.pazoki@qums.ac.ir Qazvin University of Medical Sciences scientific Ali Pazoki
Secretariat, Bouali Hospital, Bouali Street
Qazvin Iran (Islamic Republic of) 3413786165 +98 28 3332 6034 a.pazoki@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) ST Elevation Myocardial Infarction (STEMI) patients candidate for Primary Percutaneous Coronary Intervention (PPCI) 18 years 80 years Both Patients who cannot take lorazepam because of Drug interactions, including alcohol; barbiturates; antipsychotics sedatives; hypnotics; anxiolytics; opioids; antidepressants; narcotics; analgesics; sedatives; antihistamines; anticonvulsants and anesthetics. Patients who cannot take lorazepam because of lorazepam Contraindications including Allergy to Lorazepam; acute angle; closure glaucoma; severe respiratory depression and sleep apnea Patients who cannot take lorazepam because of unconsciousness I21.3 F41.9 ST elevation (STEMI) myocardial infarction of unspecified site Anxiety disorder, unspecified Treatment - Drugs Placebo Intervention group: Patients in this group receive a single dose of 1 mg/dl lorazepam from Kimidaro pharmaceutical company half an hour before Primary Percutaneous Coronary Intervention (PPCI) and after the PPCI their anxiety levels will be assessed. Control group: They are the group that receives a single dose of placebo containing microcrystalline cellulose and magnesium acetate from Alborz Daru company half an hour before primary Percutaneous Coronary Intervention (PPCI) and after the PPCI their anxiety levels will be assessed. Anxiety. Timepoint: First ward visit after Primary Percutaneous Coronary Intervention (PPCI). Method of measurement: Hospital Anxiety and Depression Scale (HADS) questionnaire. Qazvin University of Medical Sciences Approved 2022-12-17 Ethics Committee of Qazvin University of Medical Sciences Qazvin University of Medical Sciences, Bahonar boulevard, Ethics committee of Qazvin University of Medical Sciences Qazvin Qazvin Iran (Islamic Republic of)