Clinical Trial of Evaluation of the effects of intranasal desmopressin on intraoperative blood loss and quality of the surgical field during open rhinoplasty:

Evaluation of the effects of topical intranasal desmopressin on intraoperative bleeding and surgical field quality during open rhinoplasty

Clinical trial with control group with parallel groups, double-blind, randomized, phase 3 on 120 patients,PASS11 software was used for randomization.

patients 18-40 Y/O referred to Amir Al-Momenin Hospital for rhinoplasty in the period 1400-1399, are randomly divided into three groups by a researcher and two blind-sided patients are given one placebo group and two groups of drugs.Randomization is performed by a researcher who is not involved in the clinical stages of the project, and surgery is performed by a surgeon who is unaware of the study group.

People 18-40 Y/O who refer to AmirAl-Momenin Hospital,a candidate for rhinoplasty,are inclusion criteria. Exclusion criteria: 1. People with abnormal coagulation tests 2. People with a history of cardiovascular disease 3. Patients with vascular disease 4. People taking anticoagulants 5. Patients with brain diseases, hypertension and diabetes 6. Pregnancy 7. History of seizures 8.Consumers of complementary and herbal medicines and vitamin E. 9. Consumers of corticosteroids in the last two weeks 10. Consumers of diuretics 11. Vulnerable groups 12. History of previous rhinoplasty

Patients randomly divided into three groups. Each patient gets 2 spray puffs in each nostril. The first group received topical desmopressin 1 puff per nostril and normal saline spray received one puff per nostril, and the second group received 2 puffs topical desmopressin per nostril and the third group receives placebo 2 puffs per nostril. Patients do not know what group they belong to

Quality of the surgical field, blood loss, complications during operation

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.

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.

After the end of the study period

After the end of the study period

At the end of the study period, the results will be available to the public in the form of an article

In case of publication in the form of an article

ENT Center of Guilan University of Medical Sciences

In-person referral or electronic request to the ENT Center of Guilan University of Medical Sciences