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IRCT20230716058799N1 IRCT 2023-08-20 Esfahan University of Medical Sciences Comparative study of the preemptive effect of two-different doses of intravenous dexamethasone on sore throat after caesarean section under general anesthesia Comparative study of the preemptive effect of two-different doses of intravenous dexamethasone on sore throat after caesarean section under general anesthesia 2023-09-22 anticipated 90 Complete https://irct.ir/trial/71404 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Blinding description: We will explain to the participate that she will be entered one of the three groups; but she can't understand the dose and kind of substance that is used during anesthesia. Also the person who will assessment the severity of sore throat, doesn't know the kind and dose of the substance. 3 Sore throat. Intervention 1: Intervention group: The first group will receive an injection of 8 mg dexamethasone intravenous, after umbilical cord clamping. Intervention 2: Intervention group: The second group will receive an injection of 4 mg dexamethasone intravenous, after umbilical cord clamping. Intervention 3: Control group: The 3td group will receive an injection of 2cc normal salin intravenous, after umbilical cord clamping. Yes - There is a plan to make this available What will be shared: Individual participant data: All data can be shared after Unidentifiable individuals. Study protocol file can be shared after finishing the study. Statistical analysis map file can be shared after finishing the study. Informed consent form can be shared after finishing the study. Clinical study report can be shared after finishing the study. When: Start access the information 6 month after Publication of results To whom: The data is available for researchers are working in academic Institutions and also the persons are working in industry. Conditions: Using the data in other researches is Allowed after mention the source. Where to obtain: Dr. Mitra Jabalameli: jabalameli@med.mui.ac.ir Dr. Reyhanak Talakoub: talakoub@med.mui.ac.ir Fatemeh Dadvar: f.dadvar.ir@gmail.com How to obtain: At the first, the applicant introduce herself/himself and mention the goal of recieving of the data by sending email. After proving the truth, the data will send for him/her. Comments:
public Mitra Jabalameli
Alzahra hospital, Soffeh Blvd.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 jabalameli@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mitra jabalameli
Alzahra hospital, Soffeh Blvd.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 jabalameli@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Pregnant women with ASA (American Society of Anesthesiologists) II older 18 years and with gestational age 37-42 weeks who are candidate for caesarean section under general anesthesia Patient's Informed consent for participate in the research study 18 years 55 years Female Patients who are sufĺfering from a cold or sore throat before anesthesia Patients with BMI more than 40 Use of painkiller and sedative drugs before surgery Patients who have used corticosteroid during pregnancy Patients who are allergic to the drug that is used in the research study Patients who have asthma or lung disease in their past medical history patients who have grade 3 or 4 in laryngoscopy grading (difficult intubation) J04.2 Acute laryngotracheitis Prevention Prevention Placebo Intervention group: The first group will receive an injection of 8 mg dexamethasone intravenous, after umbilical cord clamping Intervention group: The second group will receive an injection of 4 mg dexamethasone intravenous, after umbilical cord clamping Control group: The 3td group will receive an injection of 2cc normal salin intravenous, after umbilical cord clamping Sore throat score base on VAS (Visual Analogue Scale). Timepoint: The intensity of sore throat will be assessed at the first, 6th, 12th and 24th hours after tracheal tube removal. Method of measurement: Visual Analogue Scale. Esfahan University of Medical Sciences Approved 2023-03-30 Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences Floor 4, No. 487, Saadat St., Dr hesabi St., janbazan St., Keshavarz Blvd. Isfahan Isfehan Iran (Islamic Republic of)