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IRCT20100126003186N12 IRCT 2019-09-24 Hamedan University of Medical Sciences Assesment of topical dexmedetomidine administration on intraoperative bleeding during functional endoscopic sinus surgery Assesment of topical dexmedetomidine administration on intraoperative bleeding and quality of the surgical field during functional endoscopic sinus surgery in patients with chronic rhinosinusitis 2018-09-23 anticipated 44 Complete https://irct.ir/trial/33341 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: For this purpose, the block randomization method will be used. Hence, six sheets will be prepared (letter A will be written on three sheets and letter B on the other three sheets for the Intervention and Control group). The sheets will be mixed together and placed in the drawer of the table. By referring to each of the eligible patients, one of the sheets will drawn randomly and based on the sheet A or B the patient will be allocated into one of the two intervention and control groups. The drawn sheets will not be returned to the drawer until all six sheets will be drowned, Blinding description: For both intervention and control groups, syringes with unspecified content (saline or dexmedetomidine) are used twenty minutes before surgery. The saline solution is drawn in a syringe similar to the dexmedetomidine solution (syringes will be prepared and identified with codes A and B by an operating room technician who will not participate in the course of the research project. So the codes will remain hidden till the end of the study and analysis). Therefore, the study will be blinded for the patients, the surgeon and the data analyser. 2-3 Chronic rhinosinusitis. Intervention 1: Intervention group: 2 microgram / kg dexmedetomidine which reached to 2 Ml with normal saline will be instilled into both nostrils, twenty minutes before surgery.(1 Ml to each nostril). Intervention 2: Control group: 2 Ml normal saline will be instilled into both nostrils, twenty minutes before surgery. 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 further information
public Dr farnaz Hashemian
Besat hospital, Shahid Motahari Blvd, Hamedan
Hamedan Iran (Islamic Republic of) 6514845411 +98 81 3264 0051 farnazhashemian@yahoo.com Hamedan University of Medical Sciences scientific Dr Farnaz Hashemian
Besat Hospital, Shahid Motahari Blvd, Hamedan
Hamedan Iran (Islamic Republic of) 6514845411 +98 81 3264 0051 farnazhashemian@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Patients with chronic rhinosinusitis with or without polyposis candidate for FESS surgery Age between 18 and 60 years Lack of history of bleeding disorders such as hemophilia and ... and the disruptions of coagulation tests (PT, PTT, INR, BT, CT and platelet counts) 18 years 60 years Both Allergy to dexmedetomidine Detection of complications during surgery or anesthesia requiring special action Patients with sinonasal tumors history of thromboembolic events history of acute or chronic renal failure take of anti-coagulant drugs for up to five days before surgery hepatic cirrhosis systemic diseases such as hypertension, diabetes, heart failure, cardiac rhythm disorders, and coronary artery disease pregnancy J32.4 Chronic pansinusitis Treatment - Surgery Treatment - Surgery Intervention group: 2 microgram / kg dexmedetomidine which reached to 2 Ml with normal saline will be instilled into both nostrils, twenty minutes before surgery.(1 Ml to each nostril) Control group: 2 Ml normal saline will be instilled into both nostrils, twenty minutes before surgery. Quality of surgical field. Timepoint: 15th, 30th, 60th and 90th minutes after surgery. Method of measurement: The quality of vision of surgical field was measured based on Boezaart Grading. Amount of bleeding during surgery. Timepoint: 15th, 30th, 60th and 90th minutes after surgery. Method of measurement: the amount of intraoperative bleeding, based on the amount of blood collected in the bottle of suction will be estimated. The amount of pain. Timepoint: 12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale. Median arterial pressure. Timepoint: 15th, 30th, 60th and 90th minutes after surgery. Method of measurement: using automated sphygmomanometer. Hamedan University of Medical Sciences Approved 2018-05-10 Ethics Committee of Hamedan University of Medical Sciences Hamadan university of medical sciences, Shahid Fahmideh Ave., Hamadan, Hamadan Hamadan Iran (Islamic Republic of)