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IRCT20170516033992N15 IRCT 2024-10-10 Oroumia University of Medical Sciences Investigating the effect of dexamethasone and Dexmedetomidine in preventing nausea and vomiting after hysterectomy Comparison of dexmedetomidine and dexamethasone efficacy in preventing postoperative nausea and vomiting after laparotomic hysterectomy 2024-11-21 anticipated 165 Complete https://irct.ir/trial/79245 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into interventions and control groups using block randomization based on generated numbers by Random allocation software. Thus, in this software, first the number of groups (3 groups) and the total number of the sample size will be entered, and then in the block section, the Block randomization method will be selected. Patients will be allocated in intervention or control groups based on generated numbers. According to the total sample size (65 patients in each group), 28 blocks of 6 will be used, Blinding description: The study will be conducted as a single-blind clinical trial. The patient the will be blind to the her allocation into interventions or control groups. Syringes containing drugs will be similar in shape and size. 3 Post-operative nausea and vomiting. Intervention 1: Intervention group: Patients in the first group will receive 8 mg of dexamethasone intravenously in a single dose after induction of anesthesia and before skin incision. Intervention 2: Intervention group: Patients in the second group will receive 1 μg/kg dexmedetomidine intravenously in a single dose after induction of anesthesia and before skin incision. Intervention 3: Control group: Patients in the third group will receive 0.15 ml/kg of ondansetron intravenously in a single dose after induction of anesthesia and before skin incision. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Dr.Tohid Karami
Kowsar hospital, Hassani Ave, Urmia, Iran.
Urmia Iran (Islamic Republic of) 5715859497 +98 44 3344 5079 karami.t@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr.Tohid Karami
Kowsar hospital, Hassani Ave, Urmia, Iran.
Urmia Iran (Islamic Republic of) 5715859497 +98 44 3344 5079 karami.t@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Elective laparotomic hysterectomy Age between 18 and 65 years 18 years 65 years Female Receiving any anti-nausea and vomiting medication in 24 hours before surgery BMI (Body mass index) above 35 kg/m2 Having allergy to any of the drugs used in this study F50.5 Nausea and vomiting Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Patients in the first group will receive 8 mg of dexamethasone intravenously in a single dose after induction of anesthesia and before skin incision. Intervention group: Patients in the second group will receive 1 μg/kg dexmedetomidine intravenously in a single dose after induction of anesthesia and before skin incision. Control group: Patients in the third group will receive 0.15 ml/kg of ondansetron intravenously in a single dose after induction of anesthesia and before skin incision. Having nausea and vomiting. Timepoint: Within 24 hours after the surgery. Method of measurement: Feeling the need to empty the contents of the stomach. Severity of nausea and vomiting. Timepoint: Within 24 hours after the surgery. Method of measurement: Visual analogue scale (VAS). Fentanyl dosage. Timepoint: Based on the dose of fentanyl received during anesthesia. Method of measurement: Milligrams. Oroumia University of Medical Sciences Approved 2024-03-13 Ethics Committee of Urmia University of Medical Sciences Urmia University of Medical Sciences, Resalat street, Jahad Blvd., Urmia, Iran Urmia West Azarbaijan Iran (Islamic Republic of)