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IRCT20210926052599N1 IRCT 2021-10-19 Islamic Azad University The comparison of the effect of ondansetron and amisulpride on post operative nausea and vomiting (PONV) in general abdominal surgeries PONV The comparison of the effect of ondansetron and amisulpride on post operative nausea and vomiting (PONV) in general abdominal surgeries 2021-10-23 anticipated 116 Complete https://irct.ir/trial/59027 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Using random numbers table, Blinding description: After confirmation of this study by the university's research committee, patients who are candidates for elective abdominal surgery with general anesthesia are introduced to the researcher by the professor of anesthesia. On the night before surgery, in order to meet the inclusion criteria and brief description of the study for the patient to be informed of the patient and get written consent of attachment number two on the patient's bedside will be present. It is also explained to the individual that their absence in this study does not cause any problems in the routine process of their treatment and is completely optional. It is also explained to them that according to appendix 1 questionnaire, 24 hours after surgery, they will be revisited to fill out the questionnaire. Patients who meet the inclusion criteria based on the criteria will be randomized using random numbers table in two groups and control will be minimized by this method of involvement and bias in patient selection by the researcher. Patients themselves do not have the right to choose to be in the case or control group. In order to blind the study on the day of surgery, the operating room personnel are unaware of the type of injectable drug and at the time of injection, syringes of the same shape and color will be provided to the anesthetic technician who does not know the content of the syringes. Finally, after collecting data and analyzing the data, the results are compared between the two groups. 3 Postoperative nausea and vomiting. Intervention 1: Intervention group: The first group will be injected intravenously at 5 mg of Amisulpride within half an hour before the surgery. Intervention 2: Control group: The second group will be injected intravenously with 4 mg of ondansetron within half an hour before the 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 No more information
public Alireaz Momennia
No 11, behind of Shahid Ghasemi sport complex, Enghelab street
Rudsar Iran (Islamic Republic of) 4481833777 +98 13 4262 4156 rudsar93@gmail.com Islamic Azad University scientific Alireza Momennia
No11, behind of Shahid Ghasemi sport complex, Enghelab street
Rudsar Iran (Islamic Republic of) 4481833777 +98 13 4262 4156 rudsar93@gmail.com Islamic Azad University Iran (Islamic Republic of) Indication for general anesthesia Being in American Society of Anesthesiologists (ASA) 1,2 anesthesia class Patient satisfaction to participate in the study Possibility of follow-up within 24 hours after abdominal surgery 18.5< Body mass index (BMI) <30 no limit no limit Both Advanced underlying disease Patient dissatisfaction to participate in the study Catching Motion sickness Excessive bleeding during surgery Severe postoperative complications R11 Nausea and vomiting Treatment - Drugs Treatment - Drugs Intervention group: The first group will be injected intravenously at 5 mg of Amisulpride within half an hour before the surgery. Control group: The second group will be injected intravenously with 4 mg of ondansetron within half an hour before the surgery. Efficacy of medication on postoperative nausea and vomiting. Timepoint: 24 hours after surgery. Method of measurement: Questionnaire. Islamic Azad University Approved 2021-02-24 Ethics committee of Islamic Azad University of Tehran Medical Sciences Islamic Azad university of Tehran medicine science, Zargandeh street, Shariati street Tehran Tehran Iran (Islamic Republic of)