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IRCT20130713013976N5 IRCT 2018-04-24 Hamedan University of Medical Sciences Effect of local desmopressin administration on intraoperative blood loss and quality of surgical field during functional endoscopic sinus surgery in patients with chronic rhinosinusitis. Effect of local desmopressin administration on intraoperative blood loss and quality of the surgical field during functional endoscopic sinus surgery in patients with chronic rhinosinusitis 2017-08-01 anticipated 88 Complete https://irct.ir/trial/13685 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Six-block randomization is used for this purpose. Six piece of paper prepared while in 3 of them letter A and in 3 others letter B was written. After mixing the papers all of them were put in the drawer desk. For any volunteer patient one of the papers will be removed randomly and by the letters they were divide in intervention or control groups. After removal of all the papers , they were charged again. This process is continued up to achieve to samples volume, Blinding description: Before starting the research and after accepting consent ,is explained to patients that they would entered in each groups of receiving topical desmopressin nasal spray(intervention) or normal saline(control group) .Because of the bottles`s same look and their filling and coding by pharmacist who participate in the research, neither researcher nor the patients have idea about contents of the bottles and their codes. 3 Chronic rhinosinusitis. Intervention 1: Intervention group: Single puff of Desmopressin nasal spray, 30 minutes before starting the surgery in each side of nasal cavity (10 micro gram in each side). This drug complete name is Desmopressin Acetate and this study has used a product of SINA-Darou factory with concentration of 100 mcg in 1 ml (each puff contains 10 mcg as noted). Intervention 2: Control group: Single puff of Saline 0.65% nasal spray , 30 minutes before starting the surgery in each side of nasal cavity.This study has used a product of SINA-Darou factory with concentration of 65 gr in 100 cc. 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 No more information
public Elham Tayebi
BESAT Hospital,Shahid Beheshti Blvd,Hamadan
Hamadan Iran (Islamic Republic of) 1234567890 +98 81 3264 0020 e_tayyebi@yahoo.com Hamedan University of Medical Sciences scientific Javaneh Jahanshahi
BESAT hospital, Hamadan
Hamadan Iran (Islamic Republic of) 1234567890 +98 81 3264 0020 J.JAHANSHAHI@UMSHA.AC.IR Hamedan University of Medical Sciences Iran (Islamic Republic of) Suffering from chronic rhinosinusitis with or without polyposis Between 18 to 60 years old Normal coagulative tests and platelet count 18 years 60 years Both Suffering from coagulative disorders like Hemophilia Suffering from sinunasal tumors History of thromboembolic accident Suffering from acute or chronic renal failure Receiving Heparin in 48 hour before surgery Receiving Aspirin in 3 days before surgery Allergy to Desmopressin Liver scirrhosis Systemic diseases like hypertension, diabet mellitus, heart failure Pregnancy Cardiac stent J32.4 Chronic pansinusitis Treatment - Drugs Placebo Intervention group: Single puff of Desmopressin nasal spray, 30 minutes before starting the surgery in each side of nasal cavity (10 micro gram in each side). This drug complete name is Desmopressin Acetate and this study has used a product of SINA-Darou factory with concentration of 100 mcg in 1 ml (each puff contains 10 mcg as noted). Control group: Single puff of Saline 0.65% nasal spray , 30 minutes before starting the surgery in each side of nasal cavity.This study has used a product of SINA-Darou factory with concentration of 65 gr in 100 cc. Visual field of surgery. Timepoint: 15,30,60,90 minutes after starting surgery. Method of measurement: Boezaart Grading. Bleeding volume. Timepoint: 15,30,60,90 minutes after starting surgery. Method of measurement: blood volume in suction s bottle. Mean arterial pressure. Timepoint: before and in points of 15,30,60 and 90 min after surgery. Method of measurement: blood pressure monitoring. Surgery duration. Timepoint: time of starting upto end of the surgery. Method of measurement: recording duration of surgery. Serum sodiume level. Timepoint: before and after the surgery. Method of measurement: serum sodiume level test. Hamedan University of Medical Sciences Approved 2017-04-08 Ethics committee of Hamadan University of Medical Science Ethics Committee of Hamadan University of Medical Science, Khaje Rashid Blv., Hamadan, Iran Hamadan Hamadan Iran (Islamic Republic of)