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IRCT20200527047578N1 IRCT 2020-09-28 Rasht University of Medical Sciences Effect of zinc in reduce of post operative sore througth Comparison of the effect of zinc impregnated pack (compared to traditional methods) on reducing the incidence of sore throat in patients undergoing Septorhinoplasty 2020-08-22 anticipated 220 Complete https://irct.ir/trial/49347 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The sampling method of this study is based on gradual referrals of patients and rhinoplasty surgery is based on random blocks whose sequences are randomly assigned through Random allocation software. The relevant list is kept in the ENT Research Center and after starting the study, based on a random list assigned to four groups (1) pharyngeal pack of wet Vibrille with normal saline (2) pharyngeal pack of gas Wet with normal saline (3) zinc-impregnated Vibrilie pack (4) normal saline-damped vibrille, Blinding description: After obtaining the agreement of the ethics committee of Guilan University of Medical Sciences, a written agreement will be given to all patients participating in this study, in which the risks, benefits and steps of the work will be explained. The study will be designed randomly. So that patients will be unaware of their group. 220 patients who are candidates for septorhinoplasty surgery who are class I or II (ASA) and are candidates for general anesthesia and GA and receiving endotracheal intubation will be randomly assigned to a single blind blind study. 3 1- The effect of zinc impregnated pharyngeal pack in comparison with other conventional methods on sore throat after septorhinoplasty 2_ The effect of zinc impregnated pharyngeal pack on postoperative vomiting. Intervention 1: All patients participating in this study will be given a written agreement outlining the risks, benefits, and steps involved. Patients are randomly divided into four intervention groups ( without control group ): (1) Patients with a pharyngeal pack made of wet vibrile with normal saline. BPI wibril made in Iran - Iran Medical Bands Manufacturing Company - will be used for the pharyngeal pack. The vibrils are the same size as the cut gas. To prepare the pack, the vibrils will be rolled in containers containing 0.9% normal saline to be evenly impregnated with the above solution. Intervention 2: Intervention group: In the second group, the bottom pack of the throat made of gas impregnated with zinc solution will be placed. 10 C 10 cm Cm made of English yarn 1/20- Number of yarn strands per square centimeter  According to standard 3061- Density of yarn per 10 cm  According to standard 3061- Density of powder at 10 cm  According to standard 3061- Width of gas yarn at least 5 mm /0. Zinc sulfate heptahydrate solution of Behsan Sar company is white and soluble in water, it will be used to impregnate the gas.To prepare the gas pack, it will be rolled in containers containing zinc sulfate heptahydrate solution to be uniformly impregnated with the above solutions. Intervention 3: Intervention group: In the third group, wet Vibrile intervention with N / S will be used. Intervention group. The properties of Vibrile and Normal Saline are in accordance with the explanations given in the previous interventions. Intervention 4: Intervention group:: In the fourth intervention group, Vibrile impregnated with zinc solution will be placed. The specifications of Vibrile and Zinc used and how to use it are in accordance with the previous cases. Yes - There is a plan to make this available What will be shared: deidentified individual participant data (IPD) collected in this study study protocol statistical analysis plan clinical study reports When: beginning from 2021-2022 To whom: academic researchers Conditions: only academic researchers Where to obtain: corresponding author/Dr Haddadi so_haddadi@yahoo.com How to obtain: They send their request with academic e-mail./among one month Comments:
public Fateme Taghi Pour Salehi
Valiasr Boulevard, at the end of Fathi Alley, No. 3
Roudsar Iran (Islamic Republic of) 4481873111 +98 13 4263 3310 sroudsari@yahoo.com Rasht University of Medical Sciences scientific Fateme Taghi Pour Salehi
Valiasr Boulevard, at the end of Fathi Alley, No. 3
Roudsar Iran (Islamic Republic of) 4481873111 +98 13 4263 3310 sroudsari@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) candidates for septorhinoplasty class 1 or 2 ASA receiving GA and septorhinoplasty 18 years 55 years Both patient with History of sore throat upper respiratory tract disease active common cold positive history of receiving analgesic before surgery drug addiction positive history of difficult intubation allergic reaction to zinc Prevention Prevention Prevention Prevention All patients participating in this study will be given a written agreement outlining the risks, benefits, and steps involved. Patients are randomly divided into four intervention groups ( without control group ): (1) Patients with a pharyngeal pack made of wet vibrile with normal saline. BPI wibril made in Iran - Iran Medical Bands Manufacturing Company - will be used for the pharyngeal pack. The vibrils are the same size as the cut gas. To prepare the pack, the vibrils will be rolled in containers containing 0.9% normal saline to be evenly impregnated with the above solution. Intervention group: In the second group, the bottom pack of the throat made of gas impregnated with zinc solution will be placed. 10 C 10 cm Cm made of English yarn 1/20- Number of yarn strands per square centimeter  According to standard 3061- Density of yarn per 10 cm  According to standard 3061- Density of powder at 10 cm  According to standard 3061- Width of gas yarn at least 5 mm /0. Zinc sulfate heptahydrate solution of Behsan Sar company is white and soluble in water, it will be used to impregnate the gas.To prepare the gas pack, it will be rolled in containers containing zinc sulfate heptahydrate solution to be uniformly impregnated with the above solutions. Intervention group: In the third group, wet Vibrile intervention with N / S will be used. Intervention group. The properties of Vibrile and Normal Saline are in accordance with the explanations given in the previous interventions Intervention group:: In the fourth intervention group, Vibrile impregnated with zinc solution will be placed. The specifications of Vibrile and Zinc used and how to use it are in accordance with the previous cases Postoperative sore throat with standard rating system and postoperative vomiting nausea (Verbal rating scale. Timepoint: Postoperative sore throat and postoperative vomiting nausea will be assessed at 0,2,4,6,24 hours. Method of measurement: Sore throat will be assessed with a standard rating system. (Zero hour) Post intensity is divided into four categories 0-3.0: Absence of sore throat, 1: Existence of mild discomfort that is expressed only by asking questions.2: The presence of moderate sore throat, which manifests itself.3: Existence of very severe sore throat that causes voice change and voice violence. Guilan Medical University Approved 2019-12-21 Ethics Committee of Guilan University of Medical Sciences Valiasr Boulevard, at the end of Fathi Alley, No. 3 roudsar Guilan Iran (Islamic Republic of)