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IRCT20190601043782N1 IRCT 2019-07-16 Islamic Azad University The effect of Metoclopramide and Ginger capsule in prevention of Laparoscopic Cholecystectomy postoperative vomiting Comparison of Metoclopramide and Ginger capsule in prevention of Laparoscopic Cholecystectomy postoperative vomiting in Khatam al-Anbiya hospital in Shahroud, Iran in 2019 2019-07-23 anticipated 100 Complete https://irct.ir/trial/40755 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The computerized block randomization (block sizes of 4 and 6) will carried out in this study. An independent clinical epidemiologist, who will not involved in the conduct of the study using a computerized block randomization program (STATA14 software) will produce the allocation codes. The randomization sequences will be concealed in opaque, sealed envelopes. The research assistant will open sealed, numbered, opaque envelopes containing allocation codes. The eligible participants will be randomized to two equal groups (ginger or metoclopramide) according to the randomization list after signing informed consent form, Blinding description: Patients will not be aware of the type of medication they receive and the second executor of the research project will complete the questionnaire at the end of the treatment without awareness about two groups. Also the data will be analyzed without any information about group allocation. 2-3 Patients underwent laparoscopic cholecystectomy. Intervention 1: Intervention group: 1 g ginger (4 capsules of 250 mg of zintoma from Isfahan Pharmaceutical Company). Intervention 2: Control group: 10 mg oral metoclopramide (4 capsules each containing one quarter tablet of metoclopramide 10 mg produced by Hakim Pharmaceutical Company in Tehran). 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 Yousef kolookhi
University Blvd - Shahrud Islamic Azad University
Shahrood Iran (Islamic Republic of) 3619943189 +98 23 3239 0360 dryousefkolookhianestezi@gmail.com Islamic Azad University scientific Yousef Kolookhi
University Blvd - Shahrud Islamic Azad University
Sharood Iran (Islamic Republic of) 3619943189 +98 23 3239 0360 dryousefkolookhianestezi@gmail.com Islamic Azad University Iran (Islamic Republic of) Informed consent to enter the study Indication of laparoscopic cholecystectomy under general anesthesia Ability to swallow capsules 18 years 65 years Both Having any type of cancer Pregnancy Having any disorders with signs of nausea and vomiting like motion sickness ... History of taking anti-nausea and vomiting drugs within three days before surgery History of hypersensitivity to ginger or metoclopramide Bowel obstruction Hepatitis Long-term treatment with corticosteroids Diabetes Obesity (BMI greater than 30) History of digestive problems such as reflux Smoking, alcohol drinking, drug abuse Taking anticoagulants such as aspirin, warfarin, etc. Taking medications that interact with metoclopramide, such as haloperidols, phenothiazines, etc. K80-K87 Disorders of gallbladder, biliary tract and pancreas Treatment - Drugs Treatment - Drugs Intervention group: 1 g ginger (4 capsules of 250 mg of zintoma from Isfahan Pharmaceutical Company) Control group: 10 mg oral metoclopramide (4 capsules each containing one quarter tablet of metoclopramide 10 mg produced by Hakim Pharmaceutical Company in Tehran) Nausea. Timepoint: Measure the severity of nausea 30 minutes, 1 hour, 6 hours and 12 hours after surgery. Method of measurement: Visual analogue scale. Vomiting. Timepoint: Measure the frequency of vomiting 30 minutes, 1 hour, 6 hours and 12 hours after surgery. Method of measurement: According to the patient record. Blood pressure. Timepoint: 30 minutes, 1 hour, 6 hours and 12 hours after surgery. Method of measurement: Mercury pressure gauge. Pain. Timepoint: 30 minutes, 1 hour, 6 hours and 12 hours after surgery. Method of measurement: Visual analogue scale. Islamic Azad University Approved 2019-01-13 Ethics Committee on Biomedical Research of the Islamic Azad University of Shahroud Branch Islamic Azad University of Shahrood Branch, Blvd university,Shahroud Town Shahroud Semnan Iran (Islamic Republic of)