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IRCT20201013049017N1 IRCT 2021-02-12 Esfahan University of Medical Sciences Pleurodesis treatment with 50% glucose Comparison of the results of pleurodesis treatment with 50% glucose with pleurodesis with bleomycin in patients with malignant pleural effusion referring to educational centers 2020-12-21 anticipated 64 Complete https://irct.ir/trial/52739 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the Convenience Sampling method, 64 eligible individuals were selected and then assigned to groups A and B using a 4-item randomized block method. For this purpose, in blocks of 4, two allocations to group A and two allocations to group B were considered and there were a total of 6 cases. The four blocks created were selected so that the sample size reached 64 people. In order to conceal random allocation, the method of opaque sealed envelopes with the random sequence was used. In this method, first, a random sequence is created by one of the mentioned methods, and based on the sample size of the research, a number of opaque envelopes are prepared and each of the random sequences created is recorded on a card and the cards are inside the envelopes. Were placed in order. At the time of enrollment, one of the envelopes was opened and the assigned group was revealed in order of eligible participants, Blinding description: In this study, the order is written by the professor as * pleurodesis No. 1 * and * pleurodesis No. 2 *, and only the performing nurses were aware of this formula, and the relevant assistant for the execution is unaware of the drug being injected into the chest. 3 Malignant pleural effusion. Intervention 1: Intervention group (A): There are 32 people in this group. the solution containing 200 cc of 50% glucose and 12.5 ml of 2% lidocaine is injected into the pleural cavity through the chest tube between the teeth, injected and the chest tube for 2 hours. It is recommended that they change their position every 15 minutes for the first 2 hours. If the chest radiograph after pleurodesis shows satisfactory lung dilation and less than 100 ml of 24-hour drainage without air leakage, the patient's chest tube is removed and the patient is discharged. Patients will be referred for follow-up immediately after pleurodesis and after removal of the Chest Tube and then at one-month intervals for 3 months. At each visit, patients are evaluated for clinical signs and symptoms associated with pleural effusion, including shortness of breath, cough, chest pain, and pulmonary sounds, followed by chest radiographs in the first and second months, and The third will be performed after pleurisy and the patients' recovery will be evaluated. Intervention 2: Intervention group(B): In this group is 32 people Plunders solution containing 12.5 cc of lidocaine 2 ٪ is mixed with 50 cc of normal saline and bleomycin (1 mg / kg) and injected into the Chest Tube using a 50 cc syringe and then for Clamps for 2 hours.It is recommended that they change their position every 15 minutes for the first 2 hours.If the chest radiograph after pleurodesis shows satisfactory lung dilation and less than 100 ml of 24-hour drainage without air leakage, the patient's chest tube is removed and the patient is discharged.Patients will be referred for follow-up immediately after pleurodesis and after removal of the Chest Tube and then at one-month intervals for 3 months.At each visit, patients are evaluated for clinical signs and symptoms associated with pleural effusion, including shortness of breath, cough, chest pain, and pulmonary sounds, followed by chest radiographs in the first and second months, and The third will be performed after pleurisy and the patients' recovery will be evaluated. 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 hamid talebzadeh
No.14, Motahhari St., South Saeb St., Marnan Square to the end of Khayyam St., Zayandehrud Building. Isfahan, Iran
Esfahan Iran (Islamic Republic of) 8185675581 +98 31 3237 8758 talebzadeh.h@med.mui.ac.ir Esfahan University of Medical Sciences scientific Milad Nazari sabet
No.14, Motahhari St., South Saeb St., Marnan Square to the end of Khayyam St., Zayandehrud Building, Isfahan, Iran
Esfahan Iran (Islamic Republic of) 8185675581 +98 31 3237 8758 miladnazarisabet64@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patient with metastatic malignancies cause to pleural effusion. Diagnosis of malignant pleural effusion based on pleural fluid cytology. Symptomatic and recurrent pleural effusion due to malignancy. No history of allergy to bleomycin . no limit no limit Both Reluctance to participate in the study J91.0 Malignant pleural effusion Treatment - Drugs Treatment - Drugs Intervention group (A): There are 32 people in this group. the solution containing 200 cc of 50% glucose and 12.5 ml of 2% lidocaine is injected into the pleural cavity through the chest tube between the teeth, injected and the chest tube for 2 hours. It is recommended that they change their position every 15 minutes for the first 2 hours. If the chest radiograph after pleurodesis shows satisfactory lung dilation and less than 100 ml of 24-hour drainage without air leakage, the patient's chest tube is removed and the patient is discharged. Patients will be referred for follow-up immediately after pleurodesis and after removal of the Chest Tube and then at one-month intervals for 3 months. At each visit, patients are evaluated for clinical signs and symptoms associated with pleural effusion, including shortness of breath, cough, chest pain, and pulmonary sounds, followed by chest radiographs in the first and second months, and The third will be performed after pleurisy and the patients' recovery will be evaluated. Intervention group(B): In this group is 32 people Plunders solution containing 12.5 cc of lidocaine 2 ٪ is mixed with 50 cc of normal saline and bleomycin (1 mg / kg) and injected into the Chest Tube using a 50 cc syringe and then for Clamps for 2 hours.It is recommended that they change their position every 15 minutes for the first 2 hours.If the chest radiograph after pleurodesis shows satisfactory lung dilation and less than 100 ml of 24-hour drainage without air leakage, the patient's chest tube is removed and the patient is discharged.Patients will be referred for follow-up immediately after pleurodesis and after removal of the Chest Tube and then at one-month intervals for 3 months.At each visit, patients are evaluated for clinical signs and symptoms associated with pleural effusion, including shortness of breath, cough, chest pain, and pulmonary sounds, followed by chest radiographs in the first and second months, and The third will be performed after pleurisy and the patients' recovery will be evaluated. Investigation of the location and severity of pleural effusion. Timepoint: Before starting the intervention: Installation of chest tube number F 28 in the area of the hypothetical middle axillary line from the fifth or sixth intercostal space in the appropriate position24 to 48 hours after chest tube implantation: Preparation of chest graph in both face and profile positions. Method of measurement: CT-Scan. Esfahan University of Medical Sciences Approved 2020-03-11 Ethics committee of Esfahan University of Medical Sciences No. 4, Hezar Jerib St., Isfahan University of Medical Sciences and Health Services- Vice Chancellor for Research and Technology,Isfahan, Iran. Esfahan Isfehan Iran (Islamic Republic of)