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

Evaluation of the effects of topical intranasal desmopressin on intraoperative bleeding and surgical field quality during endoscopic sinus surgery

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 120 patients. PASS 11 software was used for randomization.

Patients aged 18 to 55 years with chronic rhinosinusitis refered to Amir Al-Momenin Hospital in Rasht in the period of 1399-1400 are randomly divided into three groups by a blind researcher. A group of placebo and two groups of drugs are given. 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 not aware of the study group.

All patients aged 18 to 55 years with a diagnosis of chronic rhinosinusitis who have not responded to maximal drug treatment and are candidates for functional endoscopic sinus surgery. Exclusion criteria: 1- People with a history of cardiovascular diseases 2- Patients with coagulation diseases 3 - People who take anticoagulants 4- Patients with brain diseases and high blood pressure 5- Patients with nasal and sinus tumors 6- Pregnant women 7- Consumption of herbal medicines 8- History of previous sinus surgery 9- Corticosteroid drugs users 10- Consumers of diuretic drugs

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 surgical field, blood loss and complications during the 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.

At the end of the study period, all potential data can be shared after unidentifying individuals.

6 months after printing the results.

At the end of the study period, the results, data and documentation will be made available to all researchers.

Data and documentation will be provided to researchers to help advance and complete similar research projects.

ENT Research Center of Guilan Univercity of Medical Science

In-person referral or electronic request to the ENT Research Center of Guilan Univercity of Medical Science