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IRCT20160307026950N50 IRCT 2023-01-01 Esfahan University of Medical Sciences Effect of gargling rosemary extract and Ketamine on hoarseness and sore throat Comparison of the effect of gargling rosemary extract and Ketamine on hoarseness and sore throat after tracheal intubation 2022-12-22 anticipated 120 Complete https://irct.ir/trial/67426 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization is done in a simple way so that the patients are entered into groups A, B, and C according to the time of their arrival in the operating room, and this will continue until the number of patients in each group reaches 40 people, Blinding description: This is a three-way blind clinical trial; In this way, the researcher who records the patient's symptoms is different from the person who prescribes the drug and has no knowledge of the type of drug and is blind. The analysts who analyze the data collected during the study also know the type of intervention. They don't have it in any group and they are blind. Even though the patients are included in the study, they do not know the type of intervention and are blind. 3 Sore throat and Hoarseness after endotracheal intubation. Intervention 1: Intervention group A: In this group of patients, before induction of anesthesia, 30 drops of Rosemary solution (manufactured by Fadek Sepahan Pharmaceutical Company) dissolved in 30 ml of distilled water are gargled for 2-3 minutes, then 5 mg/kg Thiopental is administered to induce anesthesia. Sodium manufactured by Elixir Pharmaceutical Company, 100 Micrograms of fentanyl manufactured by Caspin Pharmaceutical Company, and 0.5 mg/kg of Atracurium manufactured by Aburihan Pharmaceutical Company is injected. Sampling and recording of symptoms are also done during and after anesthesia. Intervention 2: Intervention group B: In this group, patients gargle 40 mg of Ketamine dissolved in 30 ml of distilled water for 30 seconds before induction of anesthesia, then 5 mg/kg Thiopental is administered to induce anesthesia. Sodium manufactured by Elixir Pharmaceutical Company, 100 Micrograms of fentanyl manufactured by Caspin Pharmaceutical Company, and 0.5 mg/kg of Atracurium manufactured by Aburihan Pharmaceutical Company is injected. Sampling and recording of symptoms are also done during and after anesthesia. Intervention 3: Control group C: In this group, patients gargle 30 ml of distilled water for 2-3 minutes before induction of anesthesia, then 5 mg/kg Thiopental is administered to induce anesthesia. Sodium manufactured by Elixir Pharmaceutical Company, 100 Micrograms of fentanyl manufactured by Caspin Pharmaceutical Company, and 0.5 mg/kg of Atracurium manufactured by Aburihan Pharmaceutical Company is injected. Sampling and recording of symptoms are also done during and after 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 There is no more information
public Roza Bidkalameh
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 rozabidkalame94@gmail.com Esfahan University of Medical Sciences scientific Behzad Nazem roaya
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients 18 to 65 years old Anesthesia class I and II according to ASA criteria Candidate for general anesthesia with tracheal intubation Informed consent to enter the study 18 years 65 years Both Addiction to cigarettes and drugs Allergic to rosemary and Ketamine Diabetes Asthma and airway problems Prevention Prevention Placebo Intervention group A: In this group of patients, before induction of anesthesia, 30 drops of Rosemary solution (manufactured by Fadek Sepahan Pharmaceutical Company) dissolved in 30 ml of distilled water are gargled for 2-3 minutes, then 5 mg/kg Thiopental is administered to induce anesthesia. Sodium manufactured by Elixir Pharmaceutical Company, 100 Micrograms of fentanyl manufactured by Caspin Pharmaceutical Company, and 0.5 mg/kg of Atracurium manufactured by Aburihan Pharmaceutical Company is injected. Sampling and recording of symptoms are also done during and after anesthesia. Intervention group B: In this group, patients gargle 40 mg of Ketamine dissolved in 30 ml of distilled water for 30 seconds before induction of anesthesia, then 5 mg/kg Thiopental is administered to induce anesthesia. Sodium manufactured by Elixir Pharmaceutical Company, 100 Micrograms of fentanyl manufactured by Caspin Pharmaceutical Company, and 0.5 mg/kg of Atracurium manufactured by Aburihan Pharmaceutical Company is injected. Sampling and recording of symptoms are also done during and after anesthesia. Control group C: In this group, patients gargle 30 ml of distilled water for 2-3 minutes before induction of anesthesia, then 5 mg/kg Thiopental is administered to induce anesthesia. Sodium manufactured by Elixir Pharmaceutical Company, 100 Micrograms of fentanyl manufactured by Caspin Pharmaceutical Company, and 0.5 mg/kg of Atracurium manufactured by Aburihan Pharmaceutical Company is injected. Sampling and recording of symptoms are also done during and after anesthesia. Severity of sore throat. Timepoint: 1 hour after recovery and 6, 12, 24 and 48 hours after that. Method of measurement: Scoring from 0 to 10 based on pain intensity. Severity of hoarseness. Timepoint: 1 hour after recovery and 6, 12, 24 and 48 hours after that. Method of measurement: Scoring from 0 to 3 based on the severity of hoarseness. Blood Pressure. Timepoint: From the time of induction of anesthesia until the end of recovery. Method of measurement: sphygmomanometer. Heart Rate. Timepoint: From the time of induction of anesthesia until the end of recovery. Method of measurement: Electrocardiogram. Esfahan University of Medical Sciences Approved 2022-05-15 Ethics Committee in Biomedical Research, Isfahan University of Medical Sciences Hezar Jarib Isfahan Isfehan Iran (Islamic Republic of)