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IRCT20160818029414N5 IRCT 2019-10-12 Zanjan University of Medical Sciences Effect of Ephedrine and Ondansetron on Hypotension after Spinal Anesthesia Comparison of the Effect of Ephedrine and Ondansetron on Spinal induced Hypotension Cesarean Section 2019-11-01 anticipated 165 Complete https://irct.ir/trial/41377 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects were randomly assigned to One of three Study groups using the Sealed Envelope Method, Blinding description: The clinical evaluator, who is an Anesthetist present in the Operating Room, selects one of the three envelopes in which the letters A, B, C are written and represents the control group, Ephedrine and Ondansetron, and then the syringe containing 2 ml Injections of colorless solution into the control group: Distilled water in the Ephedrine group: 10 mg Ephedrine and in the Ondansetron group: 4 mg of the drug. Assessor and patient from syringe content and classification Groups do not know. 2-3 Hypotension after Spinal Anesthesia. Intervention 1: Intervention group: Ephedrine Group: Five minutes before the Spinal Anesthesia, two ml solution containing 10 mg ephedrine is given intravenously. Intervention 2: Intervention group: ondansetron: Five minutes before spinal anesthesia two ml solution containing 4 mg ondansetron is injected intravenously. Intervention 3: Control group: Five minutes before spinal anesthesia, two ml of distilled water is injected intravenously. 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 No more information
public Sahar Mahmoodi koli
No.48, 78 Ave, Islamic Republic Blvd, QomTown
Zanjan Iran (Islamic Republic of) 3716768757 +98 25 3289 2188 Rashtchi@zums.ac.ir Zanjan University of Medical Sciences scientific Dr.Vahide Rashtchi
Musavi Hospital, gavazang Avenue
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3133 0000 Rashtchi@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Age 18-45 year ASA I,II Elective Cesarean section under Spinal Anesthesia 18 years 45 years Female Patient dissatisfaction Infection at the spinal needle insertion site High intracranial pressure Coagulation Disorders A history of allergy to local anesthetics Heart, kidney, liver disease O74.6 Other complications of spinal and epidural anesthesia during labor and delivery Treatment - Drugs Treatment - Drugs Placebo Intervention group: Ephedrine Group: Five minutes before the Spinal Anesthesia, two ml solution containing 10 mg ephedrine is given intravenously. Intervention group: ondansetron: Five minutes before spinal anesthesia two ml solution containing 4 mg ondansetron is injected intravenously. Control group: Five minutes before spinal anesthesia, two ml of distilled water is injected intravenously. Hypotension. Timepoint: Blood pressure measurement at the beginning of the Study and immediately after the Spinal Anesthesia, every three minutes to 15 minutes and then every five minutes until the End of the Operation. Method of measurement: Blood pressure Device. Zanjan University of Medical Sciences Approved 2019-08-03 Ethics committee of Zanjan University of Medical Sciences Azadi Blvd Zanjan Zanjan Iran (Islamic Republic of)