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IRCT20141209020258N98 IRCT 2019-02-22 Arak University of Medical Sciences Comparison effects of Melatonin premedication on Propofol and induction ‎dose in abdominal surgery Comparison effects of Melatonin premedication on Propofol and induction ‎dose in abdominal surgery 2017-04-04 anticipated 88 Complete https://irct.ir/trial/34686 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with random number in division of groups in two groups A and B.Patients are divide in two groups randomly.The random sequence is parallel. Randomization method: Simple randomization. Random unit: Individual. Randomization Tool: Random Number Tables. How to build sequences: First, we set the framework for our statistical society. We started from a table point in a row or column. Given the type of code in the row, we chose the same number of digits. After that, the numbers control the path. We noticed smaller numbers of the statistical community. We have to continue this work so that the number of samples is completed.Even numbers were used for intervention group and odd numbers were used for the control group. Allocation concealment:Numbered drug containers, Blinding description: This study is double blind.Outcome assessor and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping. Outcome assessor isn't aware of grouping. Analyzer and outcome assessor know the groups in the form A and B. 2-3 abdominal surgery. Intervention 1: Intervention group: We inject 3 milligram Melatonin sublingual (Canadian manufacturer Inter natural - 3 milligrams) 50 minute before surgery (volume is brought to 3 milliliter). Intervention 2: control group: We inject placebo 50 minute before surgery ( volume is brought to 3 milliliter). Yes - There is a plan to make this available What will be shared: When we publish article in journal When: After the article is published To whom: researcher in university Conditions: If there are additional questions Where to obtain: Dr Afsaneh Norouzi How to obtain: They have to write letters to the professors and the university Comments:
public Dr Shahin Fateh
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 sh.fateh@arakkmu.ac.ir Arak University of Medical Sciences scientific Dr Afsaneh Noruzi
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3471 3638 dr.noruzi@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) 15-55 years Non-emergency abdominal surgery Surgery time 30 minutes to 1 hour and a half body mass index 19 to 25 No drug use during the past week No use of benzodiazepine-derived drugs over the past 72 hours 15 years 55 years Both Dissatisfaction R40.4 Transient alteration of awareness Treatment - Drugs Treatment - Drugs Intervention group: We inject 3 milligram Melatonin sublingual (Canadian manufacturer Inter natural - 3 milligrams) 50 minute before surgery (volume is brought to 3 milliliter). control group: We inject placebo 50 minute before surgery ( volume is brought to 3 milliliter). Anxiety. Timepoint: before and after intervention. Method of measurement: Visual analog scale. Awareness. Timepoint: before and after intervention. Method of measurement: Visual analog scale. Sedation. Timepoint: before and after intervention. Method of measurement: Visual analog scale. Arak University of Medical Sciences Approved 2017-02-27 Ethics Committee Of Arak University Of Medical Sciences Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)