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IRCT20120915010841N11 IRCT 2019-01-11 Hamedan University of Medical Sciences Comparison of two drugs in the prevention ofheadache after spinal anaestesia Comparison of the effect of Dexamethasone and Methylergonovine injection in preventing headache after spinal anesthesia in Cesarean Section 2018-07-01 anticipated 100 Complete https://irct.ir/trial/33985 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study , a randomized block design with four replications is used. we provide four sheets of paper. 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 will be assigned to one of the two Dexamethasone or Methyl ergonovine groups, depending on whether the drawn sheet is either A or B. After the random drawn out of four sheets, all the papers will be returned to the drawer and again the above procedure will continue for the next four patients until it reaches the sample volume, Blinding description: After birth of the baby and the clamp of the umbilical cord, one of the two drugs, Dexamethasone and Methylergonovine, is prepared by the anesthetist nurse (who knows nothing about the plan), in syringes of the same volume and shape, and is administered intravenously and slowly to each patient in two groups A or B by an anesthetist. Thus, the patient, the anesthetist (evaluator) and the analyzer are not aware of any prescriptive substance. 2-3 Post dural puncture headache. Intervention 1: First Intervention group: After the birth of the baby and the clamp of the umbilical cord, a single dose of 8 mg dexamethasone phosphate (2ml), produced by the Caspian Company and prepared by an anesthetic nurse in in a bottle with same volume and shape (2ml) to the other group, is injected by an anesthesiologist intravenously and slowly. Intervention 2: Second Intervention group: After the birth of the baby and the clamp of the umbilical cord, a single dose of 0.2 mg(1ml) Methergine (Methylergonovine maleate), produced by the Minoo Company and Prepared by an anesthetic nurse in a bottle with same volume and shape (2 ml) to the other group, is injected by an anesthesiologist intravenously and slowly. 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
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) Patients aged 18 to 45 years old candidates for cesarean section under spinal anesthesia Physical ASA Class 1 and 2 18 years 45 years Female Patients with a history of migraine headache Sinusitis Heart disease Hypertension Eclampsia and pre-eclampsia Liver and kidney failure History of corticosteroid use Diabetes Raynoode Phenomen Spinal anesthesia contraindications (dissatisfaction, increased intracranial pressure, local infection, coagulopathy, anemia, hypovolemia, etc.) Patients who do not have the necessary co-operation in answering questions Those who are reluctant to continue to participate in the study Patients who have failed spinal anesthesia and undergo general anesthesia O74.5 Spinal and epidural anaesthesia-induced headache during labour and delivery Prevention Prevention First Intervention group: After the birth of the baby and the clamp of the umbilical cord, a single dose of 8 mg dexamethasone phosphate (2ml), produced by the Caspian Company and prepared by an anesthetic nurse in in a bottle with same volume and shape (2ml) to the other group, is injected by an anesthesiologist intravenously and slowly. Second Intervention group: After the birth of the baby and the clamp of the umbilical cord, a single dose of 0.2 mg(1ml) Methergine (Methylergonovine maleate), produced by the Minoo Company and Prepared by an anesthetic nurse in a bottle with same volume and shape (2 ml) to the other group, is injected by an anesthesiologist intravenously and slowly Frequency of headache. Timepoint: During the surgery, the first 24 hours after surgery and one week after surgery. Method of measurement: Ask the patient. Headache time. Timepoint: During the surgery, the first 24 hours after surgery and one week after surgery. Method of measurement: Ask the patient. Headache severity. Timepoint: During the surgery, the first 24 hours after surgery and one week after surgery. Method of measurement: VAS of pain. Duration of the headache. Timepoint: During the surgery, the first 24 hours after surgery and one week after surgery. Method of measurement: Ask the patient. Nausea and vomiting. Timepoint: During the surgery. Method of measurement: Observation and ask the patient. Heart Rate. Timepoint: Every two minutes for 10 minutes and then every 10 minutes to 60 minutes. Method of measurement: Pulse oximetry device. Percentage of arterial oxygen saturation. Timepoint: Every two minutes for 10 minutes and then every 10 minutes to 60 minutes. Method of measurement: Pulse oximetry device. Dizziness. Timepoint: During the surgery. Method of measurement: ask the patient. Epigastric Pain. Timepoint: During the surgery. Method of measurement: ask the patient. Tinnitus. Timepoint: During the surgery. Method of measurement: ask the patient. Systolic Blood Pressure. Timepoint: Every two minutes for 10 minutes and then every 10 minutes to 60 minutes. Method of measurement: Non-invasive automatic barometric device. Diastolic Blood Pressure. Timepoint: Every two minutes for 10 minutes and then every 10 minutes to 60 minutes. Method of measurement: Non-invasive automatic barometric device. Mean Arterial Pressure. Timepoint: Every two minutes for 10 minutes and then every 10 minutes to 60 minutes. Method of measurement: Non-invasive automatic barometric device. Hamedan University of Medical Sciences Approved 2018-06-30 Ethics committee of Hamadan University of Medical Sciences Mahdie Street Hamadan Hamadan Iran (Islamic Republic of)