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IRCT20101211005362N29 IRCT 2022-02-26 Esfahan University of Medical Sciences Comparison between Rosemary gargle versus Lidocaine gargle on sore throat and voice violence after endotracheal intubation under general anesthesia in candidates patients for surgeries A Comparative study of the preoperative effects of Rosemary gargle versus Lidocaine gargle on sore throat and voice violence after endotracheal intubation under general anesthesia in candidates patients for surgeries 2022-02-20 anticipated 90 Complete https://irct.ir/trial/61489 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling method will be simple random allocation. Simple random allocation is the easiest and most basic approach that provides unpredictability of treatment assignment. In simple random allocation, treatment assignment is made by chance without regard to prior allocation. For randomization we enter all of samples that have entrance criteria and also not have non-entrance criteria until the volume of samples will be completed. Then we will use the app to randomize them into 3 groups completely randomized. Unit of randomization is group of persons. The tool of randomization will be Random allocation App.That will make sequences based on special programming, Blinding description: In this research patients, intervention physician and data analyzer do not have any information about groups and using drugs and also their own method. Data will be analyzed without notice to any of persons above. Only the main performer has information bout groups and each one using drugs. 3 Condition 1: Sore throat. Condition 2: Hoarseness. Intervention 1: Intervention group: In group1 we will give gargle of 30 drops of Rosemary solution 5% (Aboureihan company) which will be diluted with 30 drops of distilled water 2-3 minutes before general anesthesia. Intervention 2: Intervention group: In group2 we will give gargle of Lidocaine solution 2% (with dose of 1mg/kg) which will be diluted with 30 drops of distilled water 2-3 minutes before general anesthesia. Intervention 3: Control group: In this group we will give gargle of 30 drops of distilled water 2-3 minutes with surgical mesh before general anesthesia. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Not enough information existed.
public Dr. Mohammadreza Safavi Homami
Hezar Jerib street, Azadi square
Isfahan Iran (Islamic Republic of) 8174673461 009836683221 safavi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Mohammadreza Safavi Homami
Hezar Jerib street, Azadi square
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 3221 www.safavi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Candidate patient for surgery ASA 1,2 Age between 18 to 65 years old Informed consent of patient 18 years 65 years Both ِIV or Opioid drugs addicts Previous Allergy to drugs (Rosemary,Lidocaine) Patients with Heart,Renal pr Hepatic failure Hard Intubation (Grade 4 or upper) Malformation of airway tract R07.0 R49 Pain in throat Voice and resonance disorders Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: In group1 we will give gargle of 30 drops of Rosemary solution 5% (Aboureihan company) which will be diluted with 30 drops of distilled water 2-3 minutes before general anesthesia. Intervention group: In group2 we will give gargle of Lidocaine solution 2% (with dose of 1mg/kg) which will be diluted with 30 drops of distilled water 2-3 minutes before general anesthesia. Control group: In this group we will give gargle of 30 drops of distilled water 2-3 minutes with surgical mesh before general anesthesia. Intensity of sore throat based on VAS scale. Timepoint: Every 15 minutes at recovery, every 2 hours in first 6 hour and then at 12 and 24 hours after operation. Method of measurement: Visual Analogue Scale. Intensity of voice violence. Timepoint: Every 15 minutes at recovery, every 2 hours in first 6 hour and then at 12 and 24 hours after operation. Method of measurement: Grade, Roughness, Breathiness, Asthenia, Strain Scale (voice disorder assessment). Average satisfaction level of patients. Timepoint: First 48 hours after operation. Method of measurement: Hours count that will be measured by researcher. Average of first time liquids regime toleration. Timepoint: First 48 hours after operation. Method of measurement: Hours count that will be measured by researcher. Average of first time solids regime toleration. Timepoint: First 48 hours after operation. Method of measurement: Hours count that will be measured by researcher. Esfahan University of Medical Sciences Approved 2021-11-04 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib street, Azadi square Isfahan Isfehan Iran (Islamic Republic of)