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IRCT20221110056459N1 IRCT 2023-09-21 Shahid Beheshti University of Medical Sciences effect of aprepitant on post-operation nausea vomiting of cholecystectomy surgery Camparison of the effect of ondansetron and placebo versus ondansetron and aprepitant on post-operation nausea and vomitiing of cholecystectomy surgery 2023-03-21 anticipated 60 Complete https://irct.ir/trial/71819 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method assigns Patients to one of the intervention and control groups. The randomization method is based on random blocks of four. In this way, each study group is assigned code A or B, and different blocks of four were made by https://www.sealedenvelope.com/ website. Then patients were assigned to different blocks based on the order of entering the trial, Blinding description: Medications are coded by a nurse who is not participating in the study. The person who prescribes the medicine also does the prescription without knowing the type of medicine. In the recovery and inpatient ward, colleagues collect information without knowing the type of drug received and the groups. 3 Condition 1: Nausea. Condition 2: vomiting. Intervention 1: Intervention group: Aperpitant capsule 80 mg is prescribed one hour before the operation, and at the same time as the anti-nausea drug ondansetron 4 mg is administered intravenously. Intervention 2: Control group: At the same time as the operation, the anti-nausea drug ondansetron 4 mg is administered intravenously and a placebo capsule is administered one hour before the operation. Yes - There is a plan to make this available What will be shared: Individual data of participants and information on the main outcome, and the final report of the trial will be presented in an international article. Also, more detailed information will be accessible to researchers in coordination with the correspondence. When: The access period starts 6 months after the results are published. To whom: researchers working in academic and scientific institutions Conditions: All researchers working in academic and scientific institutions can send their request by mentioning the reason. The use of data and results of this clinical trial for personal and commercial purposes is not allowed. Where to obtain: Dr. Nasser Malekpour Alamdari: nassermalekpour@sbmu.ac.ir Dr. Maryam Abbasi: maryamabbasi1986@gmail.com How to obtain: After sending the request to the given addresses, the responsible persons will check the cases and after inquiring the identity of the requester, they will send the documents to them. This process may take up to a month. Comments:
public Nasser Malekpour Alamdari
General surgery department, Shahid Modarres Hospital, Saadat Abad Intersection, Yadegar Imam Highway
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4087 nassermalekpour@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Nasser Malekpour Alamdari
General surgery department, Shahid Modarres Hospital, Saadat Abad Intersection, Yadegar Imam Highway
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4087 nassermalekpour@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) patients with ASA health scale of 1 or 2 patients who are candidated for cholecystectomy surgery 18 years 50 years Both patients with ASA health scale of 3, 4 or 5 patients with other anesthesia methods patients with any systemic diseases such as diabetes, asthma, cardiovascular diseases, gastroesophageal reflux, severe obesity, BMI > 30, hepatorenal diseases, neuromuscular diseases, psychiatric illnesses, alcoholic patients, drug abusers, smokers pregnant or lactating patients patients presented with acute cholecystitis R11.0 R11.1 Nausea Vomiting Treatment - Drugs Treatment - Drugs Intervention group: Aperpitant capsule 80 mg is prescribed one hour before the operation, and at the same time as the anti-nausea drug ondansetron 4 mg is administered intravenously. Control group: At the same time as the operation, the anti-nausea drug ondansetron 4 mg is administered intravenously and a placebo capsule is administered one hour before the operation. The degree of nausea. Timepoint: 6 and 24 hour post-operation. Method of measurement: VAS criteria. Vomiting. Timepoint: 6 and 24 hour post-operation. Method of measurement: if vomiting happen or not. Shahid Beheshti University of Medical Sciences Approved 2022-05-24 Ethics committee of Shahid Beheshti University of Medical Sciences department of general surgery, Shahid Modarres hospital, Saadat Abad intersection, Yadegar Imam Highway Tehran Tehran Iran (Islamic Republic of)