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IRCT20200825048515N9 IRCT 2020-10-22 Esfahan University of Medical Sciences The effect of the combination of "dimenhydrinate with metoclopramide" and "dimenhydrinate with ondansetron" with "dimenhydrinate alone" in the prevention of nausea and vomiting after the surgery Comparative study of the combination of "dimenhydrinate with metoclopramide" and "dimenhydrinate with ondansetron" with "dimenhydrinate alone" in the prevention of nausea and vomiting after cataract surgery under local anesthesia 2020-11-21 anticipated 160 Complete https://irct.ir/trial/50726 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 160 eligible patients will be simple randomly easily selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into four groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the four study groups, Blinding description: To blind the study, the drugs will be prepared by an anesthesiologist before the intervention. In terms of the amount of the drug, all drugs will be reached the same volume using distilled water. These syringes will be coded and placed in the operating room and delivered daily to the anesthesiologist, who will prescribe them without knowing the type of medication. Also, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention. 3 Cataract surgery. Intervention 1: Control group: Patients in this group will be given 2 cc of distilled water half an hour before induction of general anesthesia (which includes injections of 1 cc of 1% propofol, 1 μg / kg, and 0.15 mg/kg of ketamine). Intervention 2: Intervention group: Patients in this group will be prescribed 0.5 mg/kg dimenhydrinate with 0.1 mg/kg metoclopramide half an hour before induction of general anesthesia (which includes 1 cc of 1% propofol, 1 μg / kg, and 0.15 mg/kg of ketamine). Intervention 3: Intervention group: Patients in this group will be prescribed 0.5 mg / kg dimenhydrinate with 0.4 mg of ondansetron half an hour before induction of general anesthesia (which includes injections of 1 cc of 1% propofol, 1 μg / kg and 0.15 mg / kg of ketamine). Intervention 4: Intervention group: Patients in this group will be given 0.5 mg/kg dimenhydrinate alone half an hour before induction of general anesthesia (which includes injections of 1 cc of 1% propofol, 1 μg/kg, and 0.15 mg/kg of ketamine). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Morteza Heidari
Eye Department, Feyz Hospital.
Isfahan Iran (Islamic Republic of) 8149644874 +98 31 3445 2034 m_heidari@med.mui.ac.ir Esfahan University of Medical Sciences scientific Morteza Heidari
Eye Department, Feyz Hospital.
Isfahan Iran (Islamic Republic of) 8149644874 +98 31 3445 2034 m_heidari@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Candidates for cataract surgery American Society of Anesthesiologists (ASA) physical status classification system equal I, II, and III Stability of patients' hemodynamic status 18 years 65 years Both History of motor disease Smoking or addicted patients Patients with allergies to the studied drugs Liver and vestibular disorders Taking anti-nausea drugs in the past 24 hours Prolongation of surgery more than 45 minutes. Z98.4 Cataract extraction status Placebo Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: Patients in this group will be given 2 cc of distilled water half an hour before induction of general anesthesia (which includes injections of 1 cc of 1% propofol, 1 μg / kg, and 0.15 mg/kg of ketamine). Intervention group: Patients in this group will be prescribed 0.5 mg/kg dimenhydrinate with 0.1 mg/kg metoclopramide half an hour before induction of general anesthesia (which includes 1 cc of 1% propofol, 1 μg / kg, and 0.15 mg/kg of ketamine) Intervention group: Patients in this group will be prescribed 0.5 mg / kg dimenhydrinate with 0.4 mg of ondansetron half an hour before induction of general anesthesia (which includes injections of 1 cc of 1% propofol, 1 μg / kg and 0.15 mg / kg of ketamine). Intervention group: Patients in this group will be given 0.5 mg/kg dimenhydrinate alone half an hour before induction of general anesthesia (which includes injections of 1 cc of 1% propofol, 1 μg/kg, and 0.15 mg/kg of ketamine). Severity of nausea. Timepoint: At the time of discharge from recovery and 2 and 4 hours after leaving recovery. Method of measurement: Visual Analogue Scale. Severity of vomiting. Timepoint: At the time of discharge from recovery and 2 and 4 hours after leaving recovery. Method of measurement: Visual Analogue Scale. Pain. Timepoint: 1 hour after surgery. Method of measurement: Visual Analogue Scale. Patient satisfaction. Timepoint: When referring to the ward. Method of measurement: Visual Analogue Scale. Isfahan University of Medical Sciences Approved 2020-05-30 Ethics committee of Isfahan University of Medical Sciences Hezar Jarib Ave, Azadi Square. Isfaha Isfehan Iran (Islamic Republic of)