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IRCT20191015045121N1 IRCT 2019-10-26 Ahvaz University of Medical Sciences Effect of ondansetron in prevention of hypotension following spinal anesthesia in cesarean section Evaluation of Prophylactic ondansetron in prevention of maternal hypotension following spinal anesthesia in women undergoing cesarean section 2019-12-01 anticipated 60 Complete https://irct.ir/trial/43100 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be randomly assigned into two groups of experimental and control. Each patient is given a number from 1 to 60 and assignment of patients into the study groups will be done by table of random numbers, Blinding description: Intervention (receiving normal saline orondansetron) and patient evaluation will be carried out by a physician who is blinded to both treatment groups. Also patients and statistical analyzer will not know about patient grouping. N/A Hypotension after cesarean section. Intervention 1: Intervention group: ondansetron 10 mg (Demitron, Tehran Shimi CO., Iran) will be injected intravenously 5 min before performing spinal anesthesia. Intervention 2: Control group: normal saline 10 mg will be injected intravenously 5 min before performing 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 is no more information.
public Ahmad Reza Mohtadi
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3001 3374 mohtadi-ar@ajums.ac.ir Ahvaz University of Medical Sciences scientific Ahmad Reza Mohtadi
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3001 3374 mohtadi-ar@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age between 18 to 40 years Candidate for elective cesarean section no contraindication for spinal anesthesia 18 years 40 years Female Patients with hypertension Weight more than 100 kg Motion sickness Cardiovascular disease Liver disease Migraine Allergy to ondansetron medications group Using any medication which effect the blood pressure or heart rate I95.81 Postprocedural hypotension Prevention Prevention Intervention group: ondansetron 10 mg (Demitron, Tehran Shimi CO., Iran) will be injected intravenously 5 min before performing spinal anesthesia. Control group: normal saline 10 mg will be injected intravenously 5 min before performing spinal anesthesia Systolic and diastolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and then every 5 minutes. Method of measurement: Mercury barometer. Side-effects after surgery. Timepoint: up to 2 hours after the patient entry to recovery. Method of measurement: presence of Itching, chills, nausea and vomiting based on direct observation. Ahvaz University of Medical Sciences Approved 2019-08-19 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd. Ahvaz Khouzestan Iran (Islamic Republic of)