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IRCT20120915010841N21 IRCT 2019-11-14 Hamedan University of Medical Sciences Evaluation of intravenous Propofol and Midazolam on sedation during spinal anesthesia in cesarean section Comparative Evaluation of intravenous Propofol and Midazolam on sedation and nausea & vomiting during spinal anesthesia in cesarean section 2019-10-22 anticipated 102 Complete https://irct.ir/trial/43218 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We write two letters A and on two other sheets of letter B. We mix the papers together and put them in the drawer of the table.With each of the qualified patients, one of the papers is taken out randomly and, According to the text, the patient is given one of two groups: A (Propofol) and B (Midazolam). Then, for four subsequent patients, the paper is returned to the bag again, and this process is repeated until the end of the sample volume, Blinding description: In both groups A and B, medications after spinal anesthesia one of two drugs (Propofol or Midazolam) will be prescribed.In order to prevent the medication being detectable for patients and investigators, they are prepared and injected into syringes of the same size and shape and on the adhesives A and B by the anesthetist. Since drugs are prescribed by an anesthetist, the clinician will not be aware of the type of prescribed medication that will measure and record the outcome of the study. 2 sedation and nausea & vomiting during spinal anesthesia in cesarean section. Intervention 1: Intervention group: : The amount of 0.2 mg/kg Propofol 1%(10mg/ml and made by B.BRAUN company in Germany), is injected intravenously after spinal anesthesia by anesthesiologist. Intervention 2: Intervention group: The amount of 0.02 mg/kg Midazolam(1mg/ml and made by Caspian pharmaceutical company in Iran), is injected intravenously after spinal anesthesia by anesthesiologist. 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 Because the study is not finished yet.
public Nahid Manouchehrian
Fatemieh Hospital, Pasdaran Street
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3827 7012 manuchehriann@gmail.com Hamedan University of Medical Sciences scientific Nahid Manouchehrian
Pasdaran Street
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3827 7012 manuchehriann@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) 18-45 aged pregnant women for C/S ASA CLASS 1, 2 Satisfaction to participate in the project Pregnant women who underwent cesarean section under spinal anesthesia 18 years 46 years Female sensitivity to medications used Patients who have failed spinal anesthesia and undergo general anesthesia Lung disease, heart disease, asthma, fever, hypertension, preeclampsia and eclampsia, cardiac arrhythmia Emergency Cesarean Eclampsia and Preeclampsia Multiple pregnancy Spinal anesthesia contraindications (high ICP, hypovolemia, anemia, coagulation disorders, etc.) History of allergy to eggs, soy, midazolam and propofol Use of antiemetic drugs T88.52 Failed moderate sedation during procedure Treatment - Drugs Treatment - Drugs Intervention group: : The amount of 0.2 mg/kg Propofol 1%(10mg/ml and made by B.BRAUN company in Germany), is injected intravenously after spinal anesthesia by anesthesiologist. Intervention group: The amount of 0.02 mg/kg Midazolam(1mg/ml and made by Caspian pharmaceutical company in Iran), is injected intravenously after spinal anesthesia by anesthesiologist. Sedation. Timepoint: We record ramsy sedation score in 24 hours after surgery.‎. Method of measurement: Ramsy sedation score. Nausea & vomiting. Timepoint: After surgery. Method of measurement: Observation. Systolic and Diastolic Blood Pressure. Timepoint: Every 5 minutes (from drug administration until end of surgery). Method of measurement: Non-invasive automatic barometric device. Heart Rate. Timepoint: Every 5 minutes (from drug administration until end of surgery). Method of measurement: Using a pulse oximeter. Hamedan University of Medical Sciences Approved 2019-08-10 Ethics Committee of Hamadan University of Medical Sciences Mahdieh Street Hamadan Hamadan Iran (Islamic Republic of)