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IRCT20170120032069N7 IRCT 2020-06-20 Tehran University of Medical Sciences Effect of Desmopressin on Bleeding During The Nose Job The Effect Of Desmopressin Intraoperatively On Hemorrhage During The Rhinoplasty 2020-07-22 anticipated 70 Complete https://irct.ir/trial/43010 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The blocking method will be used to select patients in one of the two intervention and control arms so that they are selected using the random numbers table of the 4 blocks and then the items will be selected and introduced with time review.Foursquare blocks of intervention group(A) and control(B) are defined on cards 1-6 (AABB,ABAB,ABBA,BBAA,BABA,BAAB), the cards are placed inside the envelope. Then the cards are selected randomly and then the random string is created from the sequence of selected cards. Patients in the intervention and control group are included in the study according to this sequence, Blinding description: Participants, principal investigators, and other investigators, physicians, nurses, anesthesiologists, pharmacists, data collectors, outcome assessors are blinded during the study about kind of drug (steroid+plasebo or steroid+omega-3) that patients will take. 3 Rhinoplasty and haemorrhage during the surgery. Intervention 1: Intervention group: Thirty minutes before the surgery, 500 ml of normal saline containing 0.1μgr / kg of Desmopressin is injected. Intervention 2: Control group: Thirty minutes before the surgery, 500 ml of normal saline is injected. Yes - There is a plan to make this available What will be shared: We will share all collected deidentified individual-patient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material),study protocol, statistical analysis Plan, informed consent form, clinical study report, analytic code. When: Beginning 3 months and ending 5 years following article publication To whom: Researchers who provide a methodologically sound proposal Conditions: To access the data, they must specify the type of data and specify the type of data to use. Where to obtain: Applicants should make a formal request by email,then they will get data by email. Email address: AH.ghabasiah@gmail.com How to obtain: After submitting the request by email, their request will be reviewed by the research team and Up to 6 months after the request is submitted, their request will be sent to their email address. Comments:
public Dr. Amir Hossein Ghabasiah
Amiralam hospital, Saadi St, Destrict12
Tehran Iran (Islamic Republic of) 1145765111 +98 21 6671 2549 AH.ghabasiah@gmail.com Tehran University of Medical Sciences scientific Dr Ardavan Tajdini
Amiralam hospital, Saadi St, Destrict12
Tehran Iran (Islamic Republic of) 1145765111 +98 21 6670 6106 Ardavan_taj@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Volunteers with no age limit who undergo the Rhinoplasty no limit no limit Both Cardiovascular disease Bleeding disorders High blood pressure Allergy to Desmopressin History of cerebrovascular attack Seizure Treatment - Drugs Placebo Intervention group: Thirty minutes before the surgery, 500 ml of normal saline containing 0.1μgr / kg of Desmopressin is injected. Control group: Thirty minutes before the surgery, 500 ml of normal saline is injected. Bleeding during rhinoplasty surgery. Timepoint: Measuring the amount of bleeding at the end of surgery. Method of measurement: The sucker bottle which is calibrated measures bleeding loss. View of surgeon on operating field. Timepoint: Measuring surgeon satisfaction at the end of surger. Method of measurement: based on the FROMME-BOEZAART Scale. The time of surgery. Timepoint: Measuring the time of surgery at the end of surgery. Method of measurement: Duration of surgery from the begining to the end of the surgery. Bleeding will be measured by the surgeon based on the FROMME-BOEZAART Scale. Timepoint: During the surgery. Method of measurement: Based on this scale, there are five grades in which the surgeon during the surgery scores the bleeding. Grade 0: No bleeding (cadaveric conditions); grade 1: Slight bleeding, no suctioning required; grade 2: Slight bleeding, occasional suctioning required; grade 3: Slight bleeding, frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed; grade 4:Moderate bleeding, frequent suctioning required, and bleeding threatens surgical field directly after suction is removed; grade 5:Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible. Tehran University of Medical Sciences Approved 2019-03-02 Vice-Chancellor in Research Affairs- Tehran University of Medical University of Medical Sciences, Ghods St, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)