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IRCT20141009019470N106 IRCT 2021-01-26 Shiraz University of Medical Sciences Comparison of the efficacy of prophylactic ondansetron and ephedrine on hypotension associated with spinal anesthesia in cesarean section Comparison of the efficacy of prophylactic ondansetron and ephedrine on hypotension associated with spinal anesthesia in cesarean section 2021-02-02 anticipated 180 Complete https://irct.ir/trial/51680 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients are randomly divided into three groups of drugs and placebo. Randomization is by using https://www.sealedenvelope.com website, Blinding description: Medications were prepared by an anesthesia nurse who were totally unaware of the nature of the study who is verified the allocation and prepared ondansetron 8 mg with 0.9% saline solution to a total volume of 10 mL or a placebo of 0.9% saline solution 10 mL and ephedrine 10 mg with 0.9% saline solution to a total volume of 10 ml. While anesthesiologist and surgeon were blinded, Neither the participants nor the investigators involved in data collection and assessing the outcomes are aware of the identity of the target drugs. The syringes had no identifying markers indicating group allocation. The nurse injected the contents of the 10-mL syringe intravenously over 60 s, 5 min before the lumbar puncture. The anesthetist is blinded to group allocation. 2-3 cesarean. Intervention 1: Intervention group one: patients will receive Ephedrine (Aterop, Belgium) 10 mg , during 5 minutes before spinal anesthesia . Intervention 2: Intervention group two: patients will receive Ondansetron (Exir, Iran) 8 mg , during 5 minutes before spinal anesthesia. Intervention 3: Control group: patients will receive10 cc normal saline as placebo during 5 minutes before spinal anesthesia. No - There is not a plan to make this available Justification or reason for not sharing IPD is Its against our policy.
public Parnian Baghban
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 parnianbaghban69@gmail.com Shiraz University of Medical Sciences scientific Saied Khademi
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 saied.khademi@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age 18 years Elective cesarean section ASA classification I-II Term and singleton pregnancy 18 years no limit Female DM Hypertensive disorder Body Mass Index 40 Complicated pregnancy such as placenta Previa, preeclampsia History of Long QT syndrome History of Electrolyte imbalance Contraindication to spinal anesthesia Failed spinal block or total spinal converted to general anesthesia History of allergy to or side effects to the study drugs. O82 Encounter for cesarean delivery without indication Prevention Prevention Placebo Intervention group one: patients will receive Ephedrine (Aterop, Belgium) 10 mg , during 5 minutes before spinal anesthesia . Intervention group two: patients will receive Ondansetron (Exir, Iran) 8 mg , during 5 minutes before spinal anesthesia. Control group: patients will receive10 cc normal saline as placebo during 5 minutes before spinal anesthesia. Hemodynamic data (SBP, DBP, MAP, HR, and SaO2). Timepoint: During Operation. Method of measurement: Manitoring. Duration of motor block. Timepoint: 7 and 15 min after intrathecal injection. Method of measurement: Bromage scale. Shiraz University of Medical Sciences Approved 2020-12-15 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 street Shiraz Fars Iran (Islamic Republic of)