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IRCT20230513058164N1 IRCT 2023-05-18 Yasouj University of Medical Sciences The comparative study of intravenous Ondansetron and Dexamethasone effects on reducing the incidence of postspinal anesthesia hypotension in elderly patients undergoing urologic surgeries The comparative study of intravenous Ondansetron and Dexamethasone Effects on Reducing the Incidence of PostSpinal Anesthesia Hypotension in Elderly Patients Undergoing Urologic Surgeries 2022-11-11 anticipated 120 Complete https://irct.ir/trial/70087 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: 120 patients. are randomly assigned based on the inclusion and exclusion crietria, using the software of the website http://www.Randomization.com . Their information are registered and informed consent obtained. Based on the central randomization system , the patient is assigned to the study groups by contacting the randomization center . This is done by a hospital colleague not involved in other stages of the study , Blinding description: .Patients are classified into three groups according to the randomization program and entered into the study according to the determined codes. In order to complete the study, the anesthesiologist assistant who is not participating in the study gives i.v. injections of Ondansetron or Dexamethasone in a 5 cc syringe preparation, 5 minutes prior to the spinal anesthesia. The patient, the caregivers of the operating room, the evaluator and the data analyst. are unaware of the type , dosage of drug injected. 3 Condition 1: Post spinal hypotension in elderly patients. Condition 2: Post Spinal Bradycardia. Intervention 1: Intervention Group A : Ondansetron Amp 4mg ,slow iv , Single Dose، 5 minutes prior to Spinal Anesthesia. Intervention 2: Intervention Group B: Dexamethasone Amp 8mg iv , Single Dose , 5 minutes prior to Spinal Anesthesia,. Intervention 3: The control group consists of 40 patients who are randomly selected and receive a study participation code. They receive no injectable drug before spinal anesthesia. Yes - There is a plan to make this available What will be shared: Data recording sheets، Result Charts , Analytical Charts available in article link and research text When: Available while article is accessible To whom: Research team Conditions: Upon formal request Where to obtain: Researcher How to obtain: Formal written request Comments:
public Masoumeh Tork
Marzdaran
Tehran Iran (Islamic Republic of) 1463755184 +98 21 4424 7963 aban253@gmail.com Yasouj University of Medical Sciences scientific Masoumeh Tork
Marzdaran
Tehran Iran (Islamic Republic of) 1463755184 +98 21 4424 7962 aban253@gmail.com Yasouj University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 65 years of age or more American Society of Anesthesiologists (ASA) physical status EF>40% Patients who do not have a contraindication for spinal anesthesia (such as coagulation disorder, thrombocytopenia ) Not allergic to local anesthetic No allergy to ondansetron or dexamethasone Not taking drugs related to steroids or serotonin (for example, selective serotonin reuptake inhibitors) Not suffering from uncontrolled cardiovascular, kidney, liver and thyroid diseases 65 years no limit Both Study Confounding Items Such as: Occurrence of Surgical Complications Such as Bleeding Hemodynamic Instability I95 R00.1 Hypotension Bradycardia, unspecified Prevention Prevention N/A Intervention Group A : Ondansetron Amp 4mg ,slow iv , Single Dose، 5 minutes prior to Spinal Anesthesia. Intervention Group B: Dexamethasone Amp 8mg iv , Single Dose , 5 minutes prior to Spinal Anesthesia,. The control group consists of 40 patients who are randomly selected and receive a study participation code. They receive no injectable drug before spinal anesthesia. Systolic Blood Pressure. Timepoint: 5 minutes before and 30 minutes following Spinal Anesthesia . Method of measurement: Sphygmomanometer. Diastolic Blood Pressure. Timepoint: 5 minutes before and 30 minutes following Spinal Anesthesia. Method of measurement: Sphygmomanometer. Heart Rate. Timepoint: 5 minutes before and 30 minutes following Spinal Anesthesia Procedure. Method of measurement: Pulse Oximeter. Yasouj University of Medical Sciences Approved 2022-10-26 Yasuj University of Medical Sciences Shahid Motahhari Blvd Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)