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IRCT20210506051200N1 IRCT 2021-06-06 Shahid Beheshti University of Medical Sciences Comparison between effects of intravenous infusion Ibuprofen vs Morphine – Paracetamol on blood Platelet function Comparison between effects of intravenous infusion Ibuprofen vs Morphine – Paracetamol on Platelet function in patients under supratentorial brain lesions resection 2021-06-22 anticipated 30 Complete https://irct.ir/trial/56323 interventional Randomization: Randomized, Blinding: Single 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 intravenous infusion Ibuprofen and Morphine – Paracetamol , Blinding description: Drugs for both groups will be prepared and coded by one of the researchers in the study. Who will be aware of the type of drug will be injected. Because the participants are unconscious during the injection, they are spontaneously blind, and therefore only the patient does not know the type of drug used. 3 supratentorial brain lesions. Intervention 1: Intervention group: infusion Ibuprofen.In group I, 400 mg of ibuprofen solution is infused intravenously over 30 minutes after removal of the brain lesion (at the beginning of Dora closure). Intervention 2: Intervention group: Morphine – Paracetamol.In group II, after removal of the brain lesion (at the beginning of Dora closure), morphine is infused 0.05 mg / kg intravenously with 1000 mg paracetamol for 30 minutes. 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 sohrab salimi
Imam Hossein Hospital, Shahid Madani St
tehran Iran (Islamic Republic of) 1617763141 +98 21 7756 7840 ssalimi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific sohrab salimi
Imam Hossein Hospital, Shahid Madani St
تهران Iran (Islamic Republic of) 1617763141 +98 21 7756 7840 m.yaseri@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All surgeries for supratentorial lesions No history of coagulation disorders No history of gastrointestinal disease No history of liver disease Discontinue drugs that cause coagulation disorders No history of heart disease No history of renal failure (creatinine clearance <70 mL / min, oliguria or dialysis within 28 days before surgery) No history of diabetes No history of asthma Absence of 2 or more of the following:Alanine aminotransferase> 165 U / L, aspartate transaminase>, 120 U / L Alkaline phosphatase> 345 U / L (three cases too normal) Inability to obtain the consent of the patient or companions No history of disorders due to hypersensitivity to ibuprofen, aspirin, nonsteroidal anti-inflammatory drugs, COX-2 inhibitors - Women in non-pregnancy status No long-term use of anticonvulsant drugs No dependence or tolerance on drugs Weight higher than 30 kg No gastrointestinal bleeding during the last 6 weeks Do not take warfarin, lithium or concomitant use of lasix and angiotensin converting enzyme inhibitors 18 years 65 years Both Hematocrit less than 25% during surgery Reduction of body temperature to less than 36 ° C D33.0 Benign neoplasm of brain, supratentorial Treatment - Drugs Treatment - Drugs Intervention group: infusion Ibuprofen.In group I, 400 mg of ibuprofen solution is infused intravenously over 30 minutes after removal of the brain lesion (at the beginning of Dora closure). Intervention group: Morphine – Paracetamol.In group II, after removal of the brain lesion (at the beginning of Dora closure), morphine is infused 0.05 mg / kg intravenously with 1000 mg paracetamol for 30 minutes. Platelet function using PFa-100(CBC, PT, PTT, Ca2+, PFa-100, INR, Fibrinogen, serum osmolality, ABG). Timepoint: Once the Dora closure begins, a blood sample is taken first to measure coagulation abnormality using the PFa-100 test. Also, one hour after the injection is completed, blood samples are taken from both groups for the PFa-100 test. Method of measurement: The PFA-100 system is a platelet function analyzer designed to measure primary platelet-dependent homeostasis.(Platelet Function Assay or Platelet Function Analyzer): PFA-100. Shahid Beheshti University of Medical Sciences Approved 2019-07-02 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)