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IRCT20180730040640N1 IRCT 2018-09-30 Boushehr University of Medical Sciences The Effect of Topical Tranexamic Acid in endoscopic sinus surgery The Effect of Topical Tranexamic Acid on Bleeding Reduction during Functional Endoscopic Sinus Surgery in choronic rhinosinousitis patient 2018-09-23 anticipated 56 Complete https://irct.ir/trial/32971 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: For random allocation of participants (individuals), a gender-based minimization method and balanced blocks will be used, Blinding description: The present study is a double-blind clinical trial on 56 patients with chronic rhinosinusitis requiring sinus endoscopic surgery which will be held in Bushehr’s Hospital.Blindness will take place by random allocation by an operating room technician.For random allocation of individuals a gender-based minimization method is going to use in form of balanced blocks.the surgeon and the person assessing will get full blindness on the study , only the nurse who is supposed to perform mesh placing will be fully informed. 3 Bleeding control and improvement of the quality of surgical field in sinus endoscopic surgery of those who need surgery that did not respond to drug therapy.. Intervention 1: Intervention group: a group of 56 patients with chronic rhinosinusitis, requiring sinus endoscopic surgery was obtained. For preoperation patient , a mesh soaked in a mixture of phenylephrine 0.05 %vol. and transamic acid at a dose of 15 mg / kg for 10 minutes will be placed in the nose(nasal cavity) of the patient by an operating room technician, then it will get extracted and operation(procedure) will begin. Bleeding rate will measure according to the Boezaart grade scale and the surgeon's satisfaction is going to measure based on the Likert scale. Intervention 2: Control group: This group is consist of 56 patients with chronic rhinosinusitis, requiring surgical endoscopy of the sinus. In this group, a mesh soaked in a solution of 0.05%vol. of phenylephrine for 10 minutes will be placed in the nose(nasal cavity) of the patient by an operating room technician, then the mesh will get extracted and operation(procedure) begins. Bleeding rate would measure according to the Boezaart grade scale and the surgeon's satisfaction will measure based on the Likert scale.Clinical practice with a control group, community based and pragmatic, double-blind, randomized. Yes - There is a plan to make this available What will be shared: No.There is not a plan to make this available When: No.There is not a plan to make this available To whom: No.There is not a plan to make this available Conditions: No.There is not a plan to make this available Where to obtain: No.There is not a plan to make this available How to obtain: No.There is not a plan to make this available Comments:
public Allahkaram Akhlaghi
Units 16, Block 1, Fatemeh Zahra pension, Moallem square, Siraf Ave
Boushehr Iran (Islamic Republic of) 7517933755 +98 77 3484 3924 Akhlaghidr@gmail.com Boushehr University of Medical Sciences scientific Allahkaram Akhlaghi
Units 16, Block 1, Fatemeh Zahra pension, Moallem square, Siraf Ave
Boushehr Iran (Islamic Republic of) 7517933755 +98 77 3484 3924 Akhlaghidr@gmail.com Boushehr University of Medical Sciences Iran (Islamic Republic of) Patients with chronic rhinosinusitis that don't not respond to drug therapy and require sinus surgery The age of the participant(s) must be between 18 and 60 years old The amount of hemoglobin of the participant should be above 10 g/dl the amount of Bleeding time (BT), Prothrombin time (PT), Partial thromboplastin time (PTT), International normalized Ratio (INR) should be normal in participants. 18 years 60 years Both Participants with cardiovascular disorders. Participants who have coagulation disorders or who are taking anticoagulant medicines(drugs) Participants with inherited coagulation disorders such as thrombophilia. Participants with coagulation disorders history in the past. Participants who have a history (record) of allergy to any drug(s) in the past. Participants who have been suffering from renal deficiency in the past. Participants with cirrhosis. Participants with chronic diseases, such as diabetes and hypertension. Participants who are pregnant. participants with malignant nasal tumor. Color blindness J32.9 Chronic sinusitis, unspecified Treatment - Surgery Treatment - Surgery Intervention group: a group of 56 patients with chronic rhinosinusitis, requiring sinus endoscopic surgery was obtained. For preoperation patient , a mesh soaked in a mixture of phenylephrine 0.05 %vol. and transamic acid at a dose of 15 mg / kg for 10 minutes will be placed in the nose(nasal cavity) of the patient by an operating room technician, then it will get extracted and operation(procedure) will begin. Bleeding rate will measure according to the Boezaart grade scale and the surgeon's satisfaction is going to measure based on the Likert scale. Control group: This group is consist of 56 patients with chronic rhinosinusitis, requiring surgical endoscopy of the sinus. In this group, a mesh soaked in a solution of 0.05%vol. of phenylephrine for 10 minutes will be placed in the nose(nasal cavity) of the patient by an operating room technician, then the mesh will get extracted and operation(procedure) begins. Bleeding rate would measure according to the Boezaart grade scale and the surgeon's satisfaction will measure based on the Likert scale.Clinical practice with a control group, community based and pragmatic, double-blind, randomized Bleeding during surgery. Timepoint: At 15th, 30th and 45th minute after intervention. Method of measurement: The Boezaart measuring scale. Surgeon's satisfaction with quality of surgical field. Timepoint: At 15th, 30th and 45th minute after intervention. Method of measurement: Likert scale plan for satisfaction. Blood pressure. Timepoint: every 15 minutes after start of surgery. Method of measurement: heart monitoring. Bleeding volume. Timepoint: every 15 minutes after start of surgery. Method of measurement: suction device. Pulse rate. Timepoint: every 15 minutes after start of surgery. Method of measurement: heart monitoring. Boushehr University of Medical Sciences Approved 2018-08-19 Ethics comittee of Bushehr University of Medical Sciences Sabzabad Blvd, Salman Farsi street, Reishehr Bushehr Boushehr Iran (Islamic Republic of)