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IRCT20160307026950N47 IRCT 2022-10-12 Esfahan University of Medical Sciences Investigating the effect of Ondansetron on nausea and itching caused by spinal Fentanyl injection Comparison of the effect of prophylactic injection of doses of 4 and 8 mg of intravenous Ondansetron on nausea and itching after spinal injection of Fentanyl in spinal anesthesia, in lower limb orthopedic surgery 2022-09-23 anticipated 90 Complete https://irct.ir/trial/65640 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: This is a simple randomized clinical trial in which patients entered the study groups by lottery; The medicines and placebo are placed in sealed, opaque, and similar form packets coded. Each code is also written on a piece of paper, folded, and placed inside a box. After entering the operating room, each patient takes one of the papers out of the box; The pocket with the same number is the intervention that will apply to him. This process continues till the number of patients will reach the desired one, Blinding description: This is a three-way blind clinical trial; In this way, the researcher who records the patient's symptoms is different from the person who injects the drug and has no knowledge of the type of drug and is blind. The analysts who analyze the data collected during the study also don't know the type of intervention in any group and they are blind. Even though the patients are included in the study, they do not know the type of intervention and are blind. 3 Spinal anesthesia. Intervention 1: Intervention group A: In this group of eligible patients, after receiving 5 ml/kg of Crystalloid fluid, they are placed on the surgical bed and cardiorespiratory monitoring is connected. Then they are subjected to spinal anesthesia with 25 μg of Fentanyl manufactured by Caspin Pharmaceutical Company and 12.5 mg of Markain manufactured by Aburihan Pharmaceutical Company. Then 30 minutes after the spinal, they receive 8 mg of Ondansetron manufactured by Elixir pharmaceutical company intravenously. The patient's symptoms including blood pressure, heart rate, and breathing rate are checked and recorded regularly every 5 minutes for 15 minutes and then every 15 minutes until the end of the fourth hour. Intervention 2: Intervention group A: In this group of eligible patients, after receiving 5 ml/kg of Crystalloid fluid, they are placed on the surgical bed and cardiorespiratory monitoring is connected. Then they are subjected to spinal anesthesia with 25 μg of Fentanyl manufactured by Caspin Pharmaceutical Company and 12.5 mg of Markain manufactured by Aburihan Pharmaceutical Company. Then 30 minutes after the spinal, they receive 4 mg of Ondansetron manufactured by Elixir pharmaceutical company intravenously. The patient's symptoms including blood pressure, heart rate, and breathing rate are checked and recorded regularly every 5 minutes for 15 minutes and then every 15 minutes until the end of the fourth hour. Intervention 3: Control group C: In this group of eligible patients, after receiving 5 ml/kg of Crystalloid fluid, they are placed on the surgical bed and cardiorespiratory monitoring is connected. Then they are subjected to spinal anesthesia with 25 μg of Fentanyl manufactured by Caspin Pharmaceutical Company and 12.5 mg of Markain manufactured by Aburihan Pharmaceutical Company. Then 30 minutes after the spinal, they receive 4 ml of distilled water manufactured by Elixir pharmaceutical company intravenously. The patient's symptoms including blood pressure, heart rate, and breathing rate are checked and recorded regularly every 5 minutes for 15 minutes and then every 15 minutes until the end of the fourth hour. 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 Sepide Hasani
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 sepideh.hassani@yandex.com Esfahan University of Medical Sciences scientific Behzad Nazem roaya
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients 18 to 65 years old Anesthesia class I and II according to ASA criteria Candidate for lower limb surgery under spinal anesthesia Informed consent to enter the study 18 years 65 years Both History of smoking, drug and psychedelic addiction Allergy to any anesthetic drugs, Ondansetron and fentanyl History of coagulation disorders High ICP Pregnancy or breastfeeding Skin infection at the injection site Anti-nausea use in the last 24 hours Prevention Prevention Placebo Intervention group A: In this group of eligible patients, after receiving 5 ml/kg of Crystalloid fluid, they are placed on the surgical bed and cardiorespiratory monitoring is connected. Then they are subjected to spinal anesthesia with 25 μg of Fentanyl manufactured by Caspin Pharmaceutical Company and 12.5 mg of Markain manufactured by Aburihan Pharmaceutical Company. Then 30 minutes after the spinal, they receive 8 mg of Ondansetron manufactured by Elixir pharmaceutical company intravenously. The patient's symptoms including blood pressure, heart rate, and breathing rate are checked and recorded regularly every 5 minutes for 15 minutes and then every 15 minutes until the end of the fourth hour. Intervention group A: In this group of eligible patients, after receiving 5 ml/kg of Crystalloid fluid, they are placed on the surgical bed and cardiorespiratory monitoring is connected. Then they are subjected to spinal anesthesia with 25 μg of Fentanyl manufactured by Caspin Pharmaceutical Company and 12.5 mg of Markain manufactured by Aburihan Pharmaceutical Company. Then 30 minutes after the spinal, they receive 4 mg of Ondansetron manufactured by Elixir pharmaceutical company intravenously. The patient's symptoms including blood pressure, heart rate, and breathing rate are checked and recorded regularly every 5 minutes for 15 minutes and then every 15 minutes until the end of the fourth hour. Control group C: In this group of eligible patients, after receiving 5 ml/kg of Crystalloid fluid, they are placed on the surgical bed and cardiorespiratory monitoring is connected. Then they are subjected to spinal anesthesia with 25 μg of Fentanyl manufactured by Caspin Pharmaceutical Company and 12.5 mg of Markain manufactured by Aburihan Pharmaceutical Company. Then 30 minutes after the spinal, they receive 4 ml of distilled water manufactured by Elixir pharmaceutical company intravenously. The patient's symptoms including blood pressure, heart rate, and breathing rate are checked and recorded regularly every 5 minutes for 15 minutes and then every 15 minutes until the end of the fourth hour. Severity of nausea. Timepoint: Every 5 minutes after spinal until 15 minutes and then every 15 minutes until the end of the 4th hour. Method of measurement: Nausea and vomiting severity behavioral scale questionnaire. Itching scale. Timepoint: Every 5 minutes after spinal until 15 minutes and then every 15 minutes until the end of the 4th hour. Method of measurement: Itching severity scale questionnaire. Esfahan University of Medical Sciences Approved 2022-07-31 Ethics Committee in Biomedical Research, Isfahan University of Medical Sciences Hezar Jarib Isfahan Isfehan Iran (Islamic Republic of)