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IRCT20120305009213N5 IRCT 2022-04-14 Cancer institute Effect of peri-operative magnesium sulfate infusion on inflammatory factors in patients with lung cancer The effect of peri-operative magnesium sulfate infusion on inflammatory factors in patients with lung cancer 2020-09-22 anticipated 44 Complete https://irct.ir/trial/50901 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into 2 groups of 22 using random numbers by the online research randomizer service (randomizer.org), Blinding description: Patients entered the study after obtaining informed consent and receiving pre-operative magnesium sulfate infusion while receiving anesthesia drugs without telling them. Also, a separate individual from the main researcher will do the statistical analysis and the data of the studied groups are coded and delivered to him without specifying the intervention and control group. N/A Lung cancer. Intervention 1: Control group: Standard protocol of anesthesia and surgery. Intervention 2: Intervention group: MgSO4 administration; in addition to standard cares, administration of MgSO4 made by Karmania Pars gene (KPG) company is added during induction of anesthesia (40 mg/kg within 10 minutes) and then infusion of maintenance dose until the end of surgery (10 mg/kg/h). Yes - There is a plan to make this available What will be shared: Evaluated data for the primary and secondary outcome When: These data are available for one year after the end of the study (2021-2022) To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: The use of this data is permitted for any research purpose Where to obtain: To receive this data, refer to the person responsible for the general inquiries How to obtain: This data will be sent within a week after sending an email to the person responsible for general inquiries of this study via university email, stating personal academic details and the reason and type of data use. Comments:
public Mahsa Hamidi Adl
Imam Khomeini Hospital Complex, End of Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 0008 dr.mahsa.hamidi@gmail.com Tehran University of Medical Sciences scientific Jalil Makarem
Imam Khomeini Hospital Complex, End of Keshavarz blvd.
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 0008 j-makarem@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with stage I (cT1N0 and cT2N0), stage II (cT1N1, cT2N1 and cT3N0) lung cancer Age 18 to 65 years old Candidate for lobectomy or pneumoectomy surgery Informed consent 18 years 65 years Both History of severe heart disease, severe systemic and functional lung disease (asthma, COPD) Electrolyte disturbance BMI below 16 concurrent history of other cancers Albumin level less than 5.2 stage IIIA (cT3N1 and cT1–3N2) lung cancer and above Small cell carcinoma HIV positive or any immunodeficiency Patients undergoing clinical trial studies at the same time as this study Dissatisfaction with participating in the study Incomplete tumor resection (potential effect on cytokine levels) Long incision on chest wall, diaphragm or mediastinum Prescribing corticosteroids Pulmonary fibrosis (affected IL-8) History of chemotherapy and radiotherapy during the past month Patients with severe chronic renal failure (creatinine clearance less than 30 ml / min) Patients with acute renal failure and anuria Patients treated with drugs that produce hypermagnesemia (such as spironolactone, eplerenone) C34 Malignant neoplasm of bronchus and lung Treatment - Drugs Treatment - Drugs Control group: Standard protocol of anesthesia and surgery Intervention group: MgSO4 administration; in addition to standard cares, administration of MgSO4 made by Karmania Pars gene (KPG) company is added during induction of anesthesia (40 mg/kg within 10 minutes) and then infusion of maintenance dose until the end of surgery (10 mg/kg/h). Evaluation of blood levels of inflammatory (IL6, IL8) and anti-inflammatory (IL10, TGF-B) factors in the study groups. Timepoint: A blood sample is collected as a control immediately after induction of anesthesia and then another sample one day after surgery. Method of measurement: Using ELISA test. Mortality rate. Timepoint: At the time of hospitalization up to 6 months after discharge. Method of measurement: Questionnaire. Cancer institute Approved 2020-09-02 Ethics committee of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences Ghods st., Keshavarz blvd. Tehran Tehran Iran (Islamic Republic of)