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IRCT20141009019470N80 IRCT 2019-06-09 Shiraz University of Medical Sciences The comparison of intravenous dexamethasone and paracetamol in the prevention of post Dural puncture headache in elective cesarean section under spinal anesthesia The comparison of intravenous dexamethasone and paracetamol in the prevention of post Dural puncture headache in elective cesarean section under spinal anesthesia 2019-06-20 anticipated 290 Complete https://irct.ir/trial/39767 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients are randomly assigned to one of two groups using the www.Randomizer.org website, Blinding description: All drug solutions of this study will be prepared by the only person who is aware of the study group in similar syringes of the same size and shape and will be provided to anesthetist for injection.Anesthesiologist, patients, and other collaborating staff will be unaware of the design of each patient's study group. 2-3 cesarean. Intervention 1: Interventional group: patients in the first group receive 8 mg dexamethasone in 100 cc normal saline via micro set and three way in 15 minutes. Intervention 2: Intervention group:Patients in the second group receive 1000 mg of paracetamol before the spinal anesthesia in 100 ml of normal saline via micro set and three way in 15 minutes. Intervention 3: Control group: Patients in the third group received 100 ml of normal saline without preservatives before spinal anesthesia in the microsurgery via micro set and three way in 15 minutes. 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 Its against our policy.
public Mohammad Hosein Pourjafarian
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 mhpj57@gmail.com Shiraz University of Medical Sciences scientific Elaheh Allahyary
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 allahyary.elaheh@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) ASA I-II Minimum NPO time = 8 hours Elective cesarean section no limit no limit Female Spinal anesthesia Contraindications of Local infection in the lumbar region (spinal cord needle entry site) Use anti-platelet and anticoagulant Sensitivity to Local anesthesia Diabetes mellitus kidney Diseases Renal failure Coagulation disorder Liver disease Heart disease History of seizure or any neurological disease Migraine and pressure headaches The history of drug addiction Failure of spinal anesthesia or multiple attempts to perform spinal anesthesia more than once Systolic blood pressure above 150 and less than 100 Preeclampsia IUGR The lack of proper growth of the uterus Weight above 100 Height less than 150 and more than 180 cm Hemoglobin less than 8 Caesarean section more than 3 times Sensitivity to dexamethasone and paracetamol P03.4 Newborn (suspected to be) affected by Cesarean delivery Prevention Prevention Placebo Interventional group: patients in the first group receive 8 mg dexamethasone in 100 cc normal saline via micro set and three way in 15 minutes. Intervention group:Patients in the second group receive 1000 mg of paracetamol before the spinal anesthesia in 100 ml of normal saline via micro set and three way in 15 minutes. Control group: Patients in the third group received 100 ml of normal saline without preservatives before spinal anesthesia in the microsurgery via micro set and three way in 15 minutes. Headache. Timepoint: At the arrival to the recovery room and after discharge from the recovery room at 6,12,24,48,72 hr. Method of measurement: Visual Analog Score. Incidence of Nausea and Vomiting. Timepoint: At the arrival to the recovery room and after discharge from the recovery room at 6,12,24,48,72 hr. Method of measurement: Observasion. Shiraz University of Medical Sciences Approved 2017-08-23 Ethics committee of Shiraz University of Medical Sciences Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand streetخیابان Shiraz Fars Iran (Islamic Republic of)