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IRCT20120430009593N14 IRCT 2021-01-19 Shahid Beheshti University of Medical Sciences ٍEvalaution of anti-tumoral effects of sera isolated from lidocaine and fentanyl infusion in the patients with breast cancer The effects of lidocaine infusion versus fentanyl on breast cancer cells apoptosis in patient under breast cancer surgery 2021-01-20 anticipated 68 Complete https://irct.ir/trial/47995 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Simple randomization Randomization unit: individual Randomization tool: Randomization will be done using the site https://www.randomizer.org which using random numbers extracted by the software, patients will be given one of the two groups of lidocaine (L) and Fentanyl (F), Blinding description: The drugs will be prepared and coded in advance by one of the researchers present in similar 50 cc syringes. The participants who will enter the study after approving the informed consent and after explaining how to group, will enter the study,with a table of random numbers assigned to one of the infusion groups of fentanyl or lidocaine and the drug in research adjusted rapidly by the anesthesiologist in the operating room, who is not part of the research team but will be aware of the type of drug, is injected at an adjusted rate based on the patient's weight and the type of drug. Patients' blood samples will be taken from all patients before induction of anesthesia and also one hour after surgery and will be sent to a laboratory for centrifugation and apoptosis index. Accordingly, patients and researchers (anesthesiologists and pathologists) are not aware of the type of drug and the relevant group. 1-2 Breast cancer. Intervention 1: Control group: Fentanyl infusion during anesthesia at a dose of 2 microg /kg until the end of surgery. Caspian Tamin Pharmaceutical Company. Intervention 2: Intervention group: Infusion at a dose of 120 mg per hour until the end of surgery. Caspian Tamin Pharmaceutical Company. Yes - There is a plan to make this available What will be shared: Some of data can be shared. When: Get started 6 month after printing results To whom: Surgeons and anesthesiologist and Academic Researchers Conditions: More research Where to obtain: Elham Memary via Email How to obtain: During an email and after its introduction, the type of expertise and explanation of the reason for requesting information, the files will be sent within 2 months Comments:
public Elham Memary
Imam Hossein Hospital, Shahid Madani St
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7756 7840 drmemary@gmail.com Shahid Beheshti University of Medical Sciences scientific Elham Memary
Imam Hossein Hospital, Shahid Madani St
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7756 7840 drmemary@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) female 18 to 75 years old candiadate for mastectomy due to breast cancer ASA I,II 18 years 75 years Female History of cardiac arrhythmias ASA IV Inflammation and infection at the surgical site History of seizures History of liver disease History of previous breast surgery except than breast biopsy Kidney failure Addiction History of mental illness C50.9 Malignant neoplasm of breast of unspecified site Treatment - Drugs Treatment - Drugs Control group: Fentanyl infusion during anesthesia at a dose of 2 microg /kg until the end of surgery. Caspian Tamin Pharmaceutical Company Intervention group: Infusion at a dose of 120 mg per hour until the end of surgery. Caspian Tamin Pharmaceutical Company Cancer Cell Apoptosis Index. Timepoint: Evaluation of apoptosis index in breast cancer cells after 12, 24 and 48 hours of serum exposure. Method of measurement: Measurement of Caspase 3, Caspase 8 and Caspase 9 factors based on immunocytochemical techniques. Shahid Beheshti University of Medical Sciences Approved 2017-09-29 The ethical commite of Shahid Beheshti Medical University Shahid Beheshti University of Medical Sciences, Shahid Erabi St, Ebne Yaman St, Shahid Chamran Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)