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IRCT20110103005536N10 IRCT 2021-04-01 Islamic Azad University Investigating the effect of intravenous ondansetron on arterial blood pressure changes and heart rate in patient undergoing surgery with spinal anesthesia Investigating the effect of intravenous ondansetron on arterial blood pressure changes and heart rate in patient undergoing inguinal hernia repair surgery with spinal anesthesia 2021-04-18 anticipated 130 Complete https://irct.ir/trial/55223 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sample size in this study is 130 participants who will be studied by simple random sampling method. For this purpose, to place patients in the case or control group, we will use the function of generating random numbers in Excel software and with Depending on whether the number is even or odd, we place the sample in the case or control group. (Even numbers will be in the case group and odd numbers will be in the control group) also, in order to hide the random sequence in the participants, from the opaque envelopes sealed with random sequence (SNOSE) using the cards related to each group, based on the order of entry of the eligible participants in the study, the envelopes are opened in order. And the group assigned to that participant is identified, Blinding description: This study is double blind and both the patient and the injector (outcome assessor) will be unaware of the contents of the syringe and only the syringe number will be recorded in the relevant checklist. The syringe may contain the drug or distilled water (placebo). 3 Spinal anesthesia. Intervention 1: Intervention group: After placing the patient on the operating table and before performing spinal anesthesia, systolic blood pressure, diastolic blood pressure, moderate blood pressure, using non-invasive measurement method, and heart rate, are measured using electrocardiogram monitoring and checked. The list will be recorded as the base parameters. Then, in the case group, 4 mg of ondansetron from Alborz company will be injected by an anesthesiologist within 30 seconds. Then, all patients will be placed under spinal anesthesia from the L4-L5 or L3-L4 space with 15 mg of bupivacaine 0.5 using a 25-gauge needle. Immediately after spinal anesthesia and placing the patient in the open arch position, systolic pressure, diastolic blood pressure, moderate blood pressure and heart rate will be measured again and recorded in a questionnaire. All of the above parameters are measured and recorded immediately after anesthesia,. Fifth minute, قه tenth minute, fifteenth minute, twentieth minute, twenty-fifth minute and thirty minutes after spinal anesthesia. In case of nausea during the operation, which is determined by asking the patient. This issue is recorded in the questionnaire. In case of vomiting, this issue is also recorded in the questionnaire. The occurrence of any shivering will also be recorded in the questionnaire. Intervention 2: Control group: After placing the patient on the operating table and before performing spinal anesthesia, systolic blood pressure, diastolic blood pressure, moderate blood pressure, using non-invasive measurement method, and heart rate, are measured using electrocardiogram monitoring and checked. The list will be recorded as the base parameters. Then in the control group, 4 ml of distilled water (placebo) will be injected by an anesthesiologist in 30 seconds. Then, all patients will be placed under spinal anesthesia from the L4-L5 or L3-L4 space with 15 mg of bupivacaine 0.5 using a 25-gauge needle. Immediately after spinal anesthesia and placing the patient in the open arch position, systolic pressure, diastolic blood pressure, moderate blood pressure and heart rate will be measured again and recorded in a questionnaire. All of the above parameters are measured and recorded immediately after anesthesia,. Fifth minute, قه tenth minute, fifteenth minute, twentieth minute, twenty-fifth minute and thirty minutes after spinal anesthesia. In case of nausea during the operation, which is determined by asking the patient. This issue is recorded in the questionnaire. In case of vomiting, this issue is also recorded in the questionnaire. The occurrence of any shivering will also be recorded in the questionnaire. Yes - There is a plan to make this available What will be shared: All research data can be shared after identifying individuals When: Start the access period after printing the results To whom: All researchers in the field of anesthesia and only by mentioning the source Conditions: It can be used only for therapeutic and research purposes and by mentioning the source Where to obtain: Dr. Mohammadreza Rafiei How to obtain: Send a request email to Dr. Rafiei and receive the data if the user approves Comments:
public Dr. Mohammadreza Rafiei
Aja univercity of medical science, Etemadzadeh St., West Fatemi Ave.,
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 mo_rafiei@armyums.ac.ir Artesh University of Medical Sciences scientific Mohamadreza Rafiei
Aja univercity of medical science, Etemadzadeh St., West Fatemi Ave.
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8802 8933 mo_rafiei@armyums.ac.ir Artesh University of Medical Sciences Iran (Islamic Republic of) The patient is a candidate for spinal hernia repair surgery by spinal anesthesia The patient has consented to spinal anesthesia 18 years no limit Both The patient has a contraindication to spinal anesthesia. The patient has hypertension The patient has a history of heart disease The patient has a history of migraine The patient has a history of allergy to ondansetron The patient has a history of taking any medication that changes blood pressure or heart rate Treatment - Drugs Placebo Intervention group: After placing the patient on the operating table and before performing spinal anesthesia, systolic blood pressure, diastolic blood pressure, moderate blood pressure, using non-invasive measurement method, and heart rate, are measured using electrocardiogram monitoring and checked. The list will be recorded as the base parameters. Then, in the case group, 4 mg of ondansetron from Alborz company will be injected by an anesthesiologist within 30 seconds. Then, all patients will be placed under spinal anesthesia from the L4-L5 or L3-L4 space with 15 mg of bupivacaine 0.5 using a 25-gauge needle. Immediately after spinal anesthesia and placing the patient in the open arch position, systolic pressure, diastolic blood pressure, moderate blood pressure and heart rate will be measured again and recorded in a questionnaire. All of the above parameters are measured and recorded immediately after anesthesia,. Fifth minute, قه tenth minute, fifteenth minute, twentieth minute, twenty-fifth minute and thirty minutes after spinal anesthesia. In case of nausea during the operation, which is determined by asking the patient. This issue is recorded in the questionnaire. In case of vomiting, this issue is also recorded in the questionnaire. The occurrence of any shivering will also be recorded in the questionnaire. Control group: After placing the patient on the operating table and before performing spinal anesthesia, systolic blood pressure, diastolic blood pressure, moderate blood pressure, using non-invasive measurement method, and heart rate, are measured using electrocardiogram monitoring and checked. The list will be recorded as the base parameters. Then in the control group, 4 ml of distilled water (placebo) will be injected by an anesthesiologist in 30 seconds. Then, all patients will be placed under spinal anesthesia from the L4-L5 or L3-L4 space with 15 mg of bupivacaine 0.5 using a 25-gauge needle. Immediately after spinal anesthesia and placing the patient in the open arch position, systolic pressure, diastolic blood pressure, moderate blood pressure and heart rate will be measured again and recorded in a questionnaire. All of the above parameters are measured and recorded immediately after anesthesia,. Fifth minute, قه tenth minute, fifteenth minute, twentieth minute, twenty-fifth minute and thirty minutes after spinal anesthesia. In case of nausea during the operation, which is determined by asking the patient. This issue is recorded in the questionnaire. In case of vomiting, this issue is also recorded in the questionnaire. The occurrence of any shivering will also be recorded in the questionnaire. Systolic blood pressure. Timepoint: Before, during and after spinal anesthesia. Method of measurement: NIBP (non invasive blood pressure) monitoring. Diastolic blood pressure. Timepoint: Before, during and after spinal anesthesia. Method of measurement: NIBP (non invasive blood pressure) monitoring. Mean arterial pressure. Timepoint: Before, during and after spinal anesthesia. Method of measurement: NIBP (non invasive blood pressure) monitoring. Hearth rate. Timepoint: Before, during and after spinal anesthesia. Method of measurement: Patient's monitoring. Nausea and vomiting. Timepoint: After spinal anesthesia. Method of measurement: Clinical observation. Chills. Timepoint: After the intervention. Method of measurement: Clinical observation. Islamic Azad University Approved 2020-01-01 Ethics Committee of Islamic Azad University, Najafabad Branch Daneshgah Blvd. Najaf abad Isfehan Iran (Islamic Republic of)