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IRCT20200708048051N3 IRCT 2021-02-20 Rasht University of Medical Sciences Evaluation of the effects of intranasal desmopressin on intraoperative blood loss and quality of the surgical field during open rhinoplasty Clinical Trial of Evaluation of the effects of intranasal desmopressin on intraoperative blood loss and quality of the surgical field during open rhinoplasty: 2021-02-19 anticipated 120 Complete https://irct.ir/trial/53970 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 Rhinoplasty surgery. Intervention 1: Intervention group 1: Topical desmopressin spray inside the nose, 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: Topical desmopressin spray 2 puffs in each nostril (equivalent to 40 micrograms) one hour before surgery. Yes - There is a plan to make this available What will be shared: After the end of the study period When: After the end of the study period To whom: At the end of the study period, the results will be available to the public in the form of an article Conditions: In case of publication in the form of an article Where to obtain: ENT Center of Guilan University of Medical Sciences How to obtain: In-person referral or electronic request to the ENT Center of Guilan University of Medical Sciences Comments:
public Maliheh Akbarpour
َAmir Almomenin Hospital, 17 shahrivar streetht
Rasht Iran (Islamic Republic of) 4139637459 +98 13 2333 8308 Akbarpour@gums.ac.ir Rasht University of Medical Sciences scientific Maliheh Akbarpour
َAmir Almomenin Hospital, 17 shahrivar streetht
Rasht Iran (Islamic Republic of) 41396459 +98 13 2333 8308 Akbarpour@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) All patients 18 to 40 years old who are candidates for rhinoplasty 18 years 40 years Both People with abnormal coagulation tests People with a history of cardiovascular disease Patients with coagulation diseases People taking anticoagulants Patients with brain diseases, hypertension and diabetes Pregnant women History of seizures Consumption of herbal supplements and vitamin E. Corticosteroid users in the last two weeks Consumers of diuretics Vulnerable groups History of previous rhinoplasty Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Topical desmopressin spray inside the nose, 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: Topical desmopressin spray 2 puffs in each nostril (equivalent to 40 micrograms) one hour before surgery Quality of the surgical field during surgery. Timepoint: During the operation. Method of measurement: The quality of the surgical field is determined by the surgeon during the operation based on the BOEZAART criteria. Rasht University of Medical Sciences Approved 2021-01-13 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)