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IRCT20191109045371N1 IRCT 2020-10-14 Esfahan University of Medical Sciences comparing the effect of two different doses of ondansetron on heart rate , blood pressure and blood oxygen saturation variation in caesarian surgery under spinal anesthesia comparing the effect of two different doses of ondansetron on heart rate , blood pressure and blood oxygen saturation variation in caesarian surgery under spinal anesthesia 2020-03-20 anticipated 60 Complete https://irct.ir/trial/49088 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study ,patients were divided on a basis of Random block making, into blocks consisting of six peoples.in each block, two patients received 8 milligrams of ondansetron, two patients received 6 milligrams of ondansetron, and two patients received normal saline. then by use of Random digits table, 15 different blocks of the so called blocks were randomly chosen. Drugs were drawn in three syringes of the same size and color by an out-of-study anesthesiologist and for every patient proportionate to his group, were given to the main anesthesiologist. Patient, main anesthesiologist, the person in charge of collecting and recording datas were unaware of the Type of the drug that was used, Blinding description: Drugs were drawn in three syringes of the same size and color by an out-of-study anesthesiologist and for every patient proportionate to his group, were given to the main anesthesiologist. Patient, main anesthesiologist, the person in charge of collecting and recording datas were unaware of the Type of the drug that was used. 3 cesarean section. Intervention 1: Intervention group 1: patients take 6 mg ondansetron. Intervention 2: Intervention group: patients take 8 mg ondansetron. Intervention 3: Control group: patients take 4cc distilled water. 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 It is not yet known if there will be a plan to make this available
public Hamid Reza Shetabi
Hezar jerib ave
Isfahan Iran (Islamic Republic of) 8174673461 0098 31 3660048 hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Hamid Reza Shetabi
Hezar jerib ave
Isfahan Iran (Islamic Republic of) 8117473461 +98 31 3668 0048 hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age between 18 to 45 years old ASA number 1 and 2 Patient is cesarian candida that term pregnancy Patient has no disease like hypertention Patient has no uncontrolled diabet Patient has no allergy to ondansetron or local anesthtic drug no forbid for spinal anesthesia Patient dosent use drugs which effect on HT35 receptor 18 years 45 years Female O75.82 Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: patients take 6 mg ondansetron Intervention group: patients take 8 mg ondansetron Control group: patients take 4cc distilled water Blood pressure. Timepoint: Befor operation and every 15 minute during operation and recovery. Method of measurement: mercury barometer. Blood oxygen saturation. Timepoint: Befor operation and every 15 minute during operation and recovery. Method of measurement: puls oxymeter. Heart rate. Timepoint: Befor operation and every 15 minute during operation and recovery. Method of measurement: puls oxymeter. Esfahan University of Medical Sciences Approved 2019-06-02 Ethics committee of Isfahan University of Medical Sciences No 48,bijan alley , hakim nezami Ave Isfahan Isfehan Iran (Islamic Republic of)