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IRCT20150217021121N5 IRCT 2020-08-05 Tabriz university of medical sciences research vice chancellor the effect of intravenous diphenhydramine and ondansetron on nausea and vomiting A comparison of the effect of intravenous diphenhydramine and ondansetron on post middle ear surgery nausea and vomiting 2020-07-22 anticipated 100 Complete https://irct.ir/trial/49805 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will construct 6 blocks in AABB, BBAA, ABAB, BABA, ABBA and BAAB using four blocks. We will assign 1 to 6 for each block. Then, using the random number table, based on the sample size, 25 units of 4 blocks will be selected so that we consider having 50 people in control group (A) and 50 people in intervention group (B). Therefore, we will do block randomization, Blinding description: In this research, the thesis owner student provides the drugs to the anesthesiologist and is the only person who is not blind to the study.The anesthesiologist, who is in charge of the patient's anesthesia management, injects the drug through coded syringes that have already been prepared by the thesis owner.So that anesthesiologist is unaware of the injected drug to patient during injection.The anesthesia nurse, who is responsible for collecting information and variables from the patient and is unaware of the type of prescribed drug, fills in the checklist during surgery and recovery.The patient is also unaware of the type of Injecting drug. 3 Postoperative nausea and vomiting. Intervention 1: Intervention group:In this group, they will receive 4mg of intravenous ondansetron before induction of anesthesia. Intervention 2: Control group:In this group, 50 mg of diphenhydramine will be injected intravenously before induction of anesthesia. Yes - There is a plan to make this available What will be shared: All potential data can be shared after making peoples unrecognizable. When: Starting 6 months after publication . To whom: Documents will be available for people working in academic institutions and also people working in businesses. Conditions: There will be no specific limitations to the utilization of the data Where to obtain: Dr .Reza Movassaghi, Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran Phone+98 413 3341994 Fax+98 41 33341994 rz_movassaghi@yahoo.com How to obtain: Applicants will access the data from the present study by sending an email to the responsible author for a maximum of one week. Comments:
public Reza Movvassaghi
Departement of Anesthesiology, Faculty of Medicine, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3334 1994 rz_movassaghi@yahoo.com Tabriz University of Medical Sciences scientific Reza Movvassaghi
Departement of Anesthesiology, Faculty of Medicine, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3334 1994 rz_movassaghi@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) All people aged 18 to 60 are candidates for middle ear surgery Has ASA grade,class I&II 18 years 60 years Both History of nausea and vomiting after surgery History of migraine headache History of digestive problems Pregnant and in menstruating period History of motion sickness Take anti-nausea medication 48 hours before surgery Y84 Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure Treatment - Drugs Treatment - Drugs Intervention group:In this group, they will receive 4mg of intravenous ondansetron before induction of anesthesia. Control group:In this group, 50 mg of diphenhydramine will be injected intravenously before induction of anesthesia. Severity of postoperative nausea and vomiting. Timepoint: In the post-anesthesia care department every 24 hours for 24 hours after surgery. Method of measurement: Based on scoring (0 = no nausea and vomiting, 1 = nausea, 2 = vomiting and 3 = vomiting more than 2 times. Tabriz university of medical sciences research vice chancellor Approved 2020-07-13 Ethic Committee of Tabriz University of Medical Sciences Vice chancellor for research, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)