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IRCT20190916044784N2 IRCT 2023-05-25 Khoram-Abad University of Medical Sciences Comparison of Ondansetron and Dexamethasone Versus Dexamethasone efficacy On Postoperative nausea and vomiting in patients with maxillofacial trauma refered to "Shohadaye Ashayer" hospital of Khorramabad Comparison of Ondansetron and Dexamethasone Versus Dexamethasone efficacy On Postoperative nausea and vomiting in patients with maxillofacial trauma 2023-06-22 anticipated 96 Complete https://irct.ir/trial/63054 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In order to equalize the production of individuals in the two groups, the Block Randomization method is used. Using this method, the sample size in the two study arms will be equal (balance), Blinding description: In order to blind the study, the severity of postoperative nausea and vomiting of patients is assessed by a person who is not aware of the study groups. Also, the patient and the person analyzing the study information are not aware of the drug injected for each patient. 3 Maxillofacial trauma. Intervention 1: Intervention group: Intervention group: For all the studied patients, after entering the operating room (both the intervention group and the control group), an IV line will be installed. In order to prevent dehydration of patients, 500 cc of Ringer's serum is injected for each patient. Then, for all patients, pre-medication with midazolam in the amount of 2-3 mg and narcotic (fentanyl) in the amount of 2-4 cc (depending on the weight of the people) is done. After 3-5 minutes, induction of anesthesia begins. In all patients, propofol at the rate of 2-2.5 mg/kg, and atrocurium at the rate of 2.5 mg/kg as a muscle relaxant are used to induce anesthesia. Before surgery and during induction of anesthesia, 8 mg of dexamethasone is injected as an IV injection for all patients (whether in the intervention or control group). All subjects undergo nasal intubation 2-4 minutes after induction of anesthesia and injection of relaxant. After intubation, all people are connected to a mechanical ventilator. During surgery, anesthesia is maintained in all patients through TIVA and propofol will be injected at the rate of 0.1 mg/kg/minute. During the surgery, depending on the patient's needs (once every 35-45 minutes), the muscle relaxant will be repeated at the rate of 0.2 mg/kg. All patients are transferred to the recovery room after surgery, and the amount of nausea and vomiting as well as their possible side effects are recorded at intervals of 1, 2, 6, 12 and 24 hours after surgery. At the end of surgery, 8 mg of ondansetron is injected through IV injection for the intervention group. Intervention 2: Control group: For the control group, no medicine is prescribed in addition to what was proposed as the main study protocol. After surgery, dexamethasone is injected for all patients on the first day at the rate of 2 doses per day and on the second day at the rate of 1 dose per day. In order to prevent disturbances in the treatment process of the patients, if nausea and vomiting of any of the patients (including from intervention and control group) was higher than one level, intervention and drug administration will be done to reduce or eliminate nausea and vomiting. This topic will be recorded in the questionnaire and study information. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Kosar Rostampur
Zomorrod 1 Apartment , Arasteh 6 Ave., Enghelab Blvd.
Khorramabad Iran (Islamic Republic of) 6816844168 +98 66 3321 8502 kosar_rostampur@yahoo.com Khoram-Abad University of Medical Sciences scientific Kosar Rostampur
Zomorrod 1 Apartment , Arasteh 6 Ave., Enghelab Blvd.
Khorramabad Iran (Islamic Republic of) 6816844168 +98 66 3321 8502 kosar_rostampur@yahoo.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) All patients referred to the "Shohadaye Ashayer" Hospital who have maxillofacial trauma and require surgery under general anesthesia. no limit no limit Both Patients who underwent another operation under general anesthesia 24 hours before maxillofacial surgery. Patients who have lost consciousness for any reason after trauma. Patients with ASA≥III. Patients with a history of Motion sickness or recent vomiting. Patients who have severe hypotension and bradycardia while surgery, and need intraoperative blood transfusion or postoperative ICU. Patients with hypersensitivity or allergy to any of the studied drugs. S02 Fracture of skull and facial bones Prevention Prevention Intervention group: Intervention group: For all the studied patients, after entering the operating room (both the intervention group and the control group), an IV line will be installed. In order to prevent dehydration of patients, 500 cc of Ringer's serum is injected for each patient. Then, for all patients, pre-medication with midazolam in the amount of 2-3 mg and narcotic (fentanyl) in the amount of 2-4 cc (depending on the weight of the people) is done. After 3-5 minutes, induction of anesthesia begins. In all patients, propofol at the rate of 2-2.5 mg/kg, and atrocurium at the rate of 2.5 mg/kg as a muscle relaxant are used to induce anesthesia. Before surgery and during induction of anesthesia, 8 mg of dexamethasone is injected as an IV injection for all patients (whether in the intervention or control group). All subjects undergo nasal intubation 2-4 minutes after induction of anesthesia and injection of relaxant. After intubation, all people are connected to a mechanical ventilator. During surgery, anesthesia is maintained in all patients through TIVA and propofol will be injected at the rate of 0.1 mg/kg/minute. During the surgery, depending on the patient's needs (once every 35-45 minutes), the muscle relaxant will be repeated at the rate of 0.2 mg/kg. All patients are transferred to the recovery room after surgery, and the amount of nausea and vomiting as well as their possible side effects are recorded at intervals of 1, 2, 6, 12 and 24 hours after surgery. At the end of surgery, 8 mg of ondansetron is injected through IV injection for the intervention group. Control group: For the control group, no medicine is prescribed in addition to what was proposed as the main study protocol. After surgery, dexamethasone is injected for all patients on the first day at the rate of 2 doses per day and on the second day at the rate of 1 dose per day. In order to prevent disturbances in the treatment process of the patients, if nausea and vomiting of any of the patients (including from intervention and control group) was higher than one level, intervention and drug administration will be done to reduce or eliminate nausea and vomiting. This topic will be recorded in the questionnaire and study information. Nausea and vomiting. Timepoint: 1, 2, 6, 12 and 24 hours after surgery. Method of measurement: Direct questions from patient. Khoram-Abad University of Medical Sciences Approved 2022-03-09 Ethics committee of Lorestan University of Medical Sciences Lorestan School of Dentistry, Between Golshan 1,2 Ave., Shafipour Blvd. Khorramabad Lorestan Iran (Islamic Republic of)