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IRCT20230514058190N1 IRCT 2023-06-25 Islamic Azad University Effect of Oxymetazoline on septorhinoplasty surgery bleeding Investigating the effect of Oxymetazoline nasal spray on septorhinoplasty surgery bleeding 2023-07-01 anticipated 30 Complete https://irct.ir/trial/70867 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: 30 eligible patients will be selected randomly. Then these people will be randomly encoded using computer software called ''Random Allocation'' and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of two intervention and control groups. 2-3 Bleeding in septorhinoplasty surgery. Intervention 1: Intervention group: For patients in the case group, two puffs of Oxynose Nasal Spray made by Raha Pharmaceutical Company, which contains Oxymetazoline Hydrochloride 0.05%, will be used 5 minutes before the start of septorhinoplasty. Intervention 2: Control group:In the control group, no intervention will be done and they will be under routine care. No - There is not a plan to make this available Justification or reason for not sharing IPD is The majority of participants agreed to participate if the confidentiality of data would be guaranteed, given the type of surgery they would undergo.
public Hossein Farzaneh
No.103, North Hojati alley ,16 meter Omid street, Hafez street
Ardabil Iran (Islamic Republic of) 5615743339 +98 45 3372 1255 hossein.frz96@gmail.com Islamic Azad University scientific Dr.Raof Mollajavadi
Basij square
Ardabil Iran (Islamic Republic of) 5615731567 +98 45 3372 8020 mollajavadi.r@gmail.com Islamic Azad University Iran (Islamic Republic of) Candidate for septorhinoplasty surgery ASA one or two Consent to participate in the study no limit no limit Both Being allergic to Oxymetazoline J34.2 Deviated nasal septum Prevention N/A Intervention group: For patients in the case group, two puffs of Oxynose Nasal Spray made by Raha Pharmaceutical Company, which contains Oxymetazoline Hydrochloride 0.05%, will be used 5 minutes before the start of septorhinoplasty. Control group:In the control group, no intervention will be done and they will be under routine care. Bleeding rate. Timepoint: During septorhinoplasty surgery. Method of measurement: Measuring the blood in the suction device. Systolic and diastolic blood pressure. Timepoint: Before induction of anesthesia, after intubation and at the end of surgery. Method of measurement: Monitoring device. Heart rate. Timepoint: Before induction of anesthesia, after intubation and at the end of surgery. Method of measurement: Monitoring device. Surgeon's satisfaction with the surgical field. Timepoint: After completion of septorhinoplasty surgery. Method of measurement: According to the opinion of the surgeon who performed the septorhinoplasty surgery. Islamic Azad University Approved 2023-02-07 Research Ethics Committees of Islamic Azad University- Ardabil Branch Basij square Ardabil Ardabil Iran (Islamic Republic of)