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IRCT20200708048051N2 IRCT 2021-02-12 Rasht University of Medical Sciences Evaluation of the effects of intranasal desmopressin on intraoperative blood loss and quality of the surgical field during functional endoscopic sinus surgery Clinical Trial of Evaluation of the effects of intranasal desmopressin on intraoperative blood loss and quality of the surgical field during functional endoscopic sinus surgery 2021-02-19 anticipated 120 Complete https://irct.ir/trial/53703 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After receiving explanations about the project, the patients were randomly divided into three groups of intervention with high-dose desmopressin, intervention with low-dose desmopressin and the control group by block randomization. Blocking is used to balance the number of samples assigned to each of the study groups. This feature helps researchers to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process. First, the software prepares a list of 4 blocks in which an equal number of people are randomly divided into three groups A, B and C. This list is placed in a separate envelope and then the envelope is closed and given to a third person. If the patient visits and is eligible, one of the envelopes will be given to the patient according to the number. After filling out the forms, the envelope is opened and based on the desired number, the patient is treated and receives the relevant intervention. Patients and researchers will not be aware of the type of intervention received, Blinding description: Individual under study, physicians caring for patients, and those who assess the outcomes, researchers of the project are kept blind to the assignment to different groups. After selecting the patients, the medications are given to the patients in similar and unnamed envelopes by a third person. The list of patients in each group will not be disclosed until the end of the data analysis. 3 chronic rhinosinusitis. Intervention 1: Intervention group 1: Topical desmopressin spray, one puff in each nostril (equivalent to 20 micrograms) one hour before surgery. Intervention 2: Intervention group 2: Topical desmopressin spray 2 puffs in each nostril (equivalent to 40 micrograms) one hour before surgery. Intervention 3: Control group: Placebo containing normal intranasal topical saline spray with the same shape as topical intranasal desmopressin spray, two puffs in each nostril one hour before surgery. Yes - There is a plan to make this available What will be shared: At the end of the study period, all potential data can be shared after unidentifying individuals. When: 6 months after printing the results. To whom: At the end of the study period, the results, data and documentation will be made available to all researchers. Conditions: Data and documentation will be provided to researchers to help advance and complete similar research projects. Where to obtain: ENT Research Center of Guilan Univercity of Medical Science How to obtain: In-person referral or electronic request to the ENT Research Center of Guilan Univercity of Medical Science Comments:
public Maliheh Akbarpour
17 Shahrivar Street, Amir Almomenin Hospital
Rasht Iran (Islamic Republic of) 4139637459 +98 13 3323 8306 akbarpour_malihe@yahoo.com Rasht University of Medical Sciences scientific Maliheh Akbarpour
17 Shahrivar street, Amir Almomenin Hospital
Rasht Iran (Islamic Republic of) 41396459 +98 13 3323 8306 akbarpour_malihe@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) all patients with chronic rhino-sinusitis with or without nasal polyps candidate for functional endoscopic sinus surgery 18 years 55 years Both patients with abnormal coagulation tests patients with history of cardiovascular disease patients with coagulopathy anticoagulant drug users patients with cerebrovascular disease patients with sinonasal tumors pregnant women herbal or vitamin E drug users sinus revision surgery corticosteroid drug users diuretic drug users patients with high systemic blood pressure J32 Chronic sinusitis Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Topical desmopressin spray, one puff in each nostril (equivalent to 20 micrograms) one hour before surgery. Intervention group 2: Topical desmopressin spray 2 puffs in each nostril (equivalent to 40 micrograms) one hour before surgery. Control group: Placebo containing normal intranasal topical saline spray with the same shape as topical intranasal desmopressin spray, two puffs in each nostril one hour before surgery. Quality of the surgical field during surgery. Timepoint: during surgery. Method of measurement: The quality of the surgical field is determined by the surgeon during the operation according to the BOEZAART criteria. Rasht University of Medical Sciences Approved 2021-01-19 Ethics committee of Guilan University of Medical Sciences Vice chancellor for Research building, opposite of Sepah Bank, Shahid Beheshti Blv. Rasht Guilan Iran (Islamic Republic of)