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IRCT20100102002963N33 IRCT 2021-10-18 Yazd University of Medical Sciences The effect of two different tranquilizer drugs on anxiety in the patients candidate for surgery The comparison of the effect of alprazolam and zaleplon on anxiety in the patients candidate for surgery 2021-10-12 anticipated 66 Complete https://irct.ir/trial/58509 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomly allocate 66 eligible applicants, we randomly divide them into two groups of 33 people. For this purpose, we use Random allocation software version 1.0 under Windows to create a sequence, and by using this software we make A list which is specified from 1 to 66 with group A or B treatment By Using this list, we give the first person who is eligible to enter the study, number one and the last person the number 66, then based on the random allocation list and by the software, it is determined which group A or B each person is in. Each drug is placed in a package and the packages are coded and based on the table of random numbers and specified code, the drug is given to patients by a third person who is not involved in evaluating patients and recording results, Blinding description: Patients and researchers themselves are unaware of which medication the patient has received, in this way, each drug is placed in a package and the packages are coded and based on the table of random numbers and specified code, the drug is given to patients by a third person who is not involved in evaluating patients and recording results. 2 The effect of drug on anxiety before induction of anesthesia. Intervention 1: Intervention group 1: Patients in this group are given oral alprazolam (0.5 mg) the night before surgery. Intervention 2: Intervention group 2: Patients in this group are given oral zaleplon (5 mg) the night before surgery. 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 I haven't decided yet. Its subscription schedule is not yet known
public Dr. Shekoufeh Behdad
Central building of Yazd University of Medical Sciences, Bahonar Square
Yazd Iran (Islamic Republic of) 8915887857 +98 35 3823 1932 drbehdad@ssu.ac.ir Yazd University of Medical Sciences scientific Dr. Shekoufeh Behdad
Central building of Yazd University of Medical Sciences, Bahonar Square
Yazd Iran (Islamic Republic of) 8915887857 +98 35 3823 1932 drbehdad@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Female patients Candidate for abdominal surgery Referred to Kowsar ward of Shahid Sadoughi Hospital in Yazd 20 years 60 years Female Existence of moderate to severe systemic disease patient history of using of sedative or tranquilizer drugs history of addiction to opioids or any sedative or psychotropic drugs disagreement for cooperation in this study Treatment - Drugs Treatment - Drugs Intervention group 1: Patients in this group are given oral alprazolam (0.5 mg) the night before surgery. Intervention group 2: Patients in this group are given oral zaleplon (5 mg) the night before surgery. Anxiety score. Timepoint: Before administration of study drug and before induction of anesthesia. Method of measurement: Based on VAS(0-10). Systolic blood pressure. Timepoint: Before administration of study drug and before induction of anesthesia. Method of measurement: Using monitoring device. Diastolic blood pressure. Timepoint: Before administration of study drug and before induction of anesthesia. Method of measurement: Using monitoring device. Mean arterial pressure. Timepoint: Before administration of study drug and before induction of anesthesia. Method of measurement: Using monitoring device. Heart rate. Timepoint: Before administration of study drug and before induction of anesthesia. Method of measurement: Using monitoring device. Yazd University of Medical Sciences Approved 2021-01-06 Ethics Committee of Shahid Sadoughi University of Medical Sciences Central building of Yazd University of Medical Sciences, Bahonar Square Yazd Yazd Iran (Islamic Republic of)