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IRCT20081013001328N2 IRCT 2022-09-06 Esfahan University of Medical Sciences Comparison of the effect of Ropivacaine-Fentanyl and Ropivacaine-Sufentanil administration on spinal anesthesia Comparison of the effect of administration of Ropivacaine-Fentanyl and Ropivacaine-Sufentanil combination on the characteristics of sensory and motor block in lower limb surgery under spinal anesthesia 2022-07-23 anticipated 105 Complete https://irct.ir/trial/64657 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: This is a simple randomized clinical trial in which patients enter the study groups by lottery; The medicines and placebo are placed in the 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 reaches the desired one, Blinding description: This is a three-blind clinical trial; In this way, before obtaining consent, the patients will be included in the study, but they do not know which group they will be in, and therefore they are blind. The researcher who records the patient's symptoms and collects the data related to the outcome variables, and also the person who analyzes the data collected during the study, do not know the type of intervention applied and therefore they are all blind. 3 . Intervention 1: Intervention group A: Patients in this group are sedated with fentanyl prodrugs at a dose of 1 µg/kg and Midazolam at a dose of 20 µg/kg after monitoring and fluid therapy, and oxygen with a flow of 6-8 liters is established for the patient. Then they receive 3 ml of Ropivacaine 0.5% made by Sinadaro company along with 25 micrograms (equivalent to 0.5cc) of Fentanyl made by Caspin Pharmaceutical Company for spinal anesthesia. Intervention 2: Intervention group B: Patients in this group are sedated with fentanyl prodrugs at a dose of 1 µg/kg and Midazolam at a dose of 20 µg/kg after monitoring and fluid therapy, and oxygen with a flow of 6-8 liters is established for the patient. Then they receive 3 ml of Ropivacaine 0.5% made by Sinadaro company along with 2.5 micrograms (equivalent to 0.5cc) of Sufentanyl made by Caspin Pharmaceutical Company for spinal anesthesia. Intervention 3: Control group C: Patients in this group are sedated with fentanyl prodrugs at a dose of 1 µg/kg and Midazolam at a dose of 20 µg/kg after monitoring and fluid therapy, and oxygen with a flow of 6-8 liters is established for the patient. Then they receive 3 ml of Ropivacaine 0.5% made by Sinadaro company along with 0.5cc of distilled water made by Caspian pharmaceutical company for 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 mora information
public Emad Khan ahmad
Hezar Jarib St
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3662 0048 Emad.khanahmad@yahoo.com Esfahan University of Medical Sciences scientific Kamran Montazeri
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 8597 montazeri@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18 years and above Candidate for lower limb surgery under spinal anesthesia ASA class I and II informed consent to enter the study 18 years no limit Both Infection at the injection site Coagulation disorders and the use of anticoagulants Suffering from high intracranial pressure Drug addiction Patients with body mass index (BMI) above 30 Diagnosis Diagnosis Placebo Intervention group A: Patients in this group are sedated with fentanyl prodrugs at a dose of 1 µg/kg and Midazolam at a dose of 20 µg/kg after monitoring and fluid therapy, and oxygen with a flow of 6-8 liters is established for the patient. Then they receive 3 ml of Ropivacaine 0.5% made by Sinadaro company along with 25 micrograms (equivalent to 0.5cc) of Fentanyl made by Caspin Pharmaceutical Company for spinal anesthesia. Intervention group B: Patients in this group are sedated with fentanyl prodrugs at a dose of 1 µg/kg and Midazolam at a dose of 20 µg/kg after monitoring and fluid therapy, and oxygen with a flow of 6-8 liters is established for the patient. Then they receive 3 ml of Ropivacaine 0.5% made by Sinadaro company along with 2.5 micrograms (equivalent to 0.5cc) of Sufentanyl made by Caspin Pharmaceutical Company for spinal anesthesia. Control group C: Patients in this group are sedated with fentanyl prodrugs at a dose of 1 µg/kg and Midazolam at a dose of 20 µg/kg after monitoring and fluid therapy, and oxygen with a flow of 6-8 liters is established for the patient. Then they receive 3 ml of Ropivacaine 0.5% made by Sinadaro company along with 0.5cc of distilled water made by Caspian pharmaceutical company for spinal anesthesia. The time to onset of the numbing. Timepoint: Every 30 seconds from the moment of injection to the first feeling of numbing at the level of the L4 vertebra. Method of measurement: Pinprick and Timer. Duration of reaching the maximum level of numbing. Timepoint: Every 30 seconds from the moment of injection to numbing of the T12 vertebra surface. Method of measurement: Pinprick and Timer. Duration of return of numbing. Timepoint: From the time of drug injection until the return of sensation at S1 level. Method of measurement: Pinprick and Timer. Blood Pressure. Timepoint: before the injection, 3, 5, and 10 minutes after the spinal and then every 15 minutes until the end of recovery. Method of measurement: Sphymomanmeter. Heart Rate. Timepoint: before the injection, 3, 5, and 10 minutes after the spinal and then every 15 minutes until the end of recovery. Method of measurement: ECG monitoring. Oxygen Saturation. Timepoint: From the moment of entering the operating room until the end of recovery. Method of measurement: Pulse Oximeter. Esfahan University of Medical Sciences Approved 2022-02-10 Ethics Committee in Biomedical Research, Isfahan University of Medical Sciences Hezar Jarib St Isfahan Isfehan Iran (Islamic Republic of)