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IRCT20201028049175N6 IRCT 2021-03-02 Arak University of Medical Sciences Evaluation of anti analgesic and anti inflammatory drugs effect on decreasing of post operative nausea vomiting after cesarean section Effect of combined Paracetamol(Apotel) and Dexamethasone versus Paracetamol(Apotel) on post operative nausea vomiting after cesarean section 2021-02-19 anticipated 100 Complete https://irct.ir/trial/53780 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: To create simple random sequences web randomization (com.graphpad.www) dual group and for concealment, closed envelope method with random sequence (SNOSE) will be used.Random sequences will be recorded on the cards and then sequentally puted in the envelopes.In order to preserve random sequences the outer surface of the envelopes are numbered, respectively. Finally, the lid of the letter envelopes was pasted and it is placed inside the boxes, respectively.At the time of participants registration, one of the envelopes will be opened and the allocation group, will be revealed, Blinding description: Patients blindness: According to injecting of Dexamethasone in one group of study 30 minutes before spinal anesthesia, in another group distilled water will be injected to the patients in same time and measure. Researcher blindness: Drugs will be ordered by specialist, so the researcher who filled the check lists is blind. 3 Nausea and vomitting after cesarean. Intervention 1: Intervention group:8 mg of Dexamethasone (Daroo pakhsh company) intravenously will be injected to the patients, 30 minutes before spinal anesthesia and 1 gr of Apotel (Exir company) intravenously will be injected immediately after spinal anesthesia. Intervention 2: Control group:2 cc of distilled water intravenously will be injected to the patients, 30 minutes before spinal anesthesia and 1 gr of Apotel (Exir company)intravenously will be injected immediately after spinal anesthesia. 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 There are no more data.
public Maryam Maktabi
West side of Emam Khomeini street, beside of gas company
Arak Iran (Islamic Republic of) 3816149369 +98 86 3277 6063 Dr.maryam.maktabi@gmail.com Arak University of Medical Sciences scientific Alireza Kamali
Valiasr hospital, Valiasr square
Arak Iran (Islamic Republic of) 3814957558 086-32222003-8 alikamaliir@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Age between 18-45 years Having informed consent Having ASA I and II Nulliparous Singleton pregnancy Patients with elective cesarean Patients with spinal anesthesia Patients with Pfannenstiel incision in surgery. 18 years 45 years Female Underlying disease (i.e renal, liver, cardiac and pulmonary disease) History of allergy to the drugs of study Addiction or long term using of opiate Coagulopathy or use of anticoagulant drugs Disability for pain scoring Suffering from preeclampsia or HELLP or eclampsia or hepatitis Urgency cesarean section R11 Nausea and vomiting Treatment - Drugs Treatment - Drugs Intervention group:8 mg of Dexamethasone (Daroo pakhsh company) intravenously will be injected to the patients, 30 minutes before spinal anesthesia and 1 gr of Apotel (Exir company) intravenously will be injected immediately after spinal anesthesia. Control group:2 cc of distilled water intravenously will be injected to the patients, 30 minutes before spinal anesthesia and 1 gr of Apotel (Exir company)intravenously will be injected immediately after spinal anesthesia. Nausea happening after cesarean section untill 24 hours after surgery. Timepoint: In recovery room and 2,4,6,12,24 hours after surgery. Method of measurement: Asking of patient. Vomitting score after cesarean section untill 24 hours after surgery. Timepoint: In recovery room and 2,4,6,12,24 hours after surgery. Method of measurement: VAS (Visual Analog Scale) score. Arak University of Medical Sciences Approved 2021-01-03 Ethics committee of Arak University of Medical Sciences Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Basij square Arak Markazi Iran (Islamic Republic of)