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IRCT20190409043219N2 IRCT 2019-09-28 Tehran University of Medical Sciences Determination the effect of low dose of dexamethasone on prevention of post operative nausea and vomiting after elective cesarean section Comparison of the effect of the ondansetrone 4 mg in combination with dexamethasone 4 mg and dexamethasone 8 mg on post operative nausea and vomiting after elective cesarean section under spinal anesthesia 2019-08-23 anticipated 135 Complete https://irct.ir/trial/41391 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will randomly allocated to 3 treatment groups using balanced block randomization.There are 3 interventions therefore the blocks will contain 6 letters(AABBCC) and we will have 22 blocks in total (135/6=22). We can have twenty block models that they will be arranged in random order and finally the 2 next blocks will select randomly among that 20 models and will be added, Blinding description: The study medications are prepared by an anesthesiologist who does not otherwise participated in the study and then are enveloped and sealed and patient′s code are recorded on it. The envelopes will open in operation room just before spinal anesthesia by an anesthesiologist who is blinded to patient′s study group and type of solution and then will inject intravenously. All of the nurses and patients are blinded to the type of solution and to the patient′s study group allocation.also the nurse who fill the questionnaire. 3 post operative nausea and vomiting. Intervention 1: 4 mg ondansetron plus 4 mg dexamethasone just before spinal anesthesia intravenously. Intervention 2: Intervention group: 4 mg ondansetron plus 8mg dexamethasone just before spinal anesthesia intravenously. Intervention 3: Control group: 4 mg ondansetron increased to 3 cc by adding normal saline just before spinal anesthesia intravenously. 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 Saghar Samimi Sadeh
Yas hospital,North Ostad nejatollahi Ave,Karim Khan Zand Street
Tehran Iran (Islamic Republic of) 1598718311 +98 21 4216 0310 sagharsamimi@yahoo.com Tehran University of Medical Sciences scientific Saghar Samimi Sadeh
Yas Hospital,North Ostan Nejatollahi Ave,Karim Khan Zand Street
Tehran Iran (Islamic Republic of) 1598718311 +98 21 4216 0310 sagharsamimi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Female 18-45 yrs ASA class 1-2 Uncomplicated pregnancy Elective cesarean section 18 years 45 years Female history of motion sickness and severe morning sickness symptoms of cardiovascular ,hepatic,renal and psychotic disease Refuse to cooperate with researchers R68.8 Other general symptoms and signs Prevention Prevention Prevention 4 mg ondansetron plus 4 mg dexamethasone just before spinal anesthesia intravenously. Intervention group: 4 mg ondansetron plus 8mg dexamethasone just before spinal anesthesia intravenously. Control group: 4 mg ondansetron increased to 3 cc by adding normal saline just before spinal anesthesia intravenously Incidence of nausea and vomiting after cesarean section. Timepoint: Intraoperatively, in the recovery room and 3,6,12,24 hrs postoperatively. Method of measurement: The frequency of nausea and vomiting will be recorded on a questionnaire. Severity of postoperative nausea. Timepoint: intraoperatively, in recovery room and 3,6,12,24 hrs postoperatively. Method of measurement: the severity of nausea will be recorded on a questionnaire. Tehran University of Medical Sciences Approved 2017-09-11 Ethics and Clinical Studies Committee of Tehran University of Medical Sciences Yas Hospital,North Ostad Nejatollahi Ave, Karim Khan Zand St. Tehran Tehran Iran (Islamic Republic of)