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IRCT20230627058595N1 IRCT 2023-07-31 Esfahan University of Medical Sciences Investigating the effect of gargling normal saline and tinctured solution of sage and marshmallow plants on the incidence of sore throat, cough, hoarseness and severity of sore throat after endotracheal intubation in patients under general anesthesia. A comparative study of the effect of gargling with normal saline and gargling with a tincture of sage and Alcea plants on the incidence of sore throat, cough and hoarseness and the severity of sore throat after endotracheal intubation in patients under general anesthesia. 2023-08-06 anticipated 114 Complete https://irct.ir/trial/71350 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: All patients will be anesthetized in the same way (both in the phase of induction of anesthesia and in the phase of maintnance of anesthesia). Intubation and the anesthesia process will be performed by an anesthetist (under the supervision of an anesthesiologist), who are experts, experienced and professional.The type of anesthesia method, gases and drugs used for anesthesia will be the same for all patients. The size of the endotracheal tube used will be 8 for men and 7.5 for women. (36) All endotracheal tubes will be the same and made of UPVC (polyvinyl chloride).Patients will be told that there are three groups in this study, and you may be randomly assigned to one of the three groups (test or control group) in this study.Sage plant and khatami flower are made into tincture form by Iranian medical doctor, then 20-15 drops diluted in half a glass of water will be given to the patients. (according to the order of a doctor specializing in Iranian medicine), Randomization description: Randomization method and description of each method: simple randomization Randomization Unit: Individual Randomization Tool: Like a table of random numbers How to make a random sequence: numbers 1-38 for the first intervention group (normal saline gargle), numbers 39 to 77 for the second intervention group (sage plant and marshmallow tincture) and numbers 78 to 114 will be considered for the control group. . Explanation about concealment: use of opaque sealed envelope with random sequence, Blinding description: The three studied groups will be named with codes A, B and C, and one of the researchers will keep these codes secret until the end of the data analysis. Therefore, the research assistants (one of the researchers) as well as the patients (participants) and the statistical analyst (data analyst) will be blinded to the groups (triple blind). 3 Occurrence of sore throat, cough, hoarseness and throat severity. Intervention 1: The first intervention group: In the first intervention group, gargling 15-20 drops of normal saline will be administered to the patients 2 hours before the start of surgery and immediately before anesthesia (before prescribing any premed or pre-anesthetic medicine to the patient). The solution will have a suitable temperature for drinking (25°C). Gargling the solution will be done once for 30 seconds. Intervention 2: The second intervention group: in this group, gargle 15-20 drops of the tincture of sage and marshmallow diluted in half a glass of water for patients 2 hours before surgery and immediately before anesthesia (before prescribing any Primed or pre-anesthetic medicine will be prescribed to the patient. The solution will have a suitable temperature for drinking (25 degrees Celsius). Gargling the solution will be done once and for 30 seconds. The sage plant and jasmine flower will be made into tincture form by an Iranian medical doctor, then 20-15 drops diluted in half a glass of water will be given to the patients. (based on the order of a doctor specializing in Iranian medicine). To prepare the tinctured herbal composition, an Iranian medical specialist made 50 grams of the sage plant (branches and flowers) along with 50 grams of marshmallow plant (roots, leaves, and flowers) in the form of a tincture (hydroalcoholic solution). And it will be combined with a ratio of 1 to 5 (1 for sage plant and marshmallow and 5 for hydroalcohol solution). 100 grams of plants will be kept in 500 grams of hydroalcoholic solution. This mixture is kept in a cool place for two weeks and then strained. We dilute 15 to 20 drops of the tinctured solution in half a glass of water and give it to the patient to gargle. Intervention 3: Control group: Control group: In the control group, gargling 15-20 drops of distilled water as a placebo will be administered to the patients 2 hours before surgery and immediately before anesthesia (before prescribing any premed or pre-anesthetic medicine to the patient). All solutions will have a suitable temperature for drinking (25 degrees Celsius). Gargling the solutions will be done once for 30 seconds. 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 further information
public Fatemeh Shahnazari
Esfahan, Nursing and Midwifery Faculty,Operating room department
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7630 fati.shahnazari373@gmail.com Esfahan University of Medical Sciences scientific Fatemeh Shahnazari
Esfahan, Nursing and Midwifery Faculty,Operating room department
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7630 fati.shahnazari373@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) • Patients under general anesthesia with intratracheal intubation • Not having a history of allergy to herbal medicine (especially the components of sage and Alcea plants or other plants from the same family) • Patients with physical condition 1 and 2 (PS or ASA) (either do not have an underlying disease or have a controlled underlying disease.) • Absence of underlying diseases of the oral cavity • Absence of specific diseases related to sore throat, such as viral and bacterial diseases. • Not taking certain drugs, especially NSAIDs, narcotics, benzodiazepines, and neuropsychiatric drugs • Age between 18 and 65 years (5) • Patients who do not have any doubts about difficult intubation during clinical examination. • Abdominal surgery that does not last more than two hours. (14) • Patients do not suffer from chronic cough and allergies 18 years 65 years Both • The inability of the patient to continue to cooperate for any reason, such as a decrease in the level of consciousness, the death of the patient, etc.• Lack of complete access to the patient• Changing the anesthesia method during surgery for any reason• Performing intubation and laryngoscopy more than once for the patient• Length of laryngoscopy for intubation more than 30 seconds• Patients who have difficult general anesthesia and intubation process.• If the duration of surgery lasts more than 2 hours.• If NGT is used for the patient.• People who use a tracheal tube other than size 5/7 for women and 8 for men.• The patient's unwillingness to continue treatment and cooperation Treatment - Drugs Treatment - Drugs Placebo The first intervention group: In the first intervention group, gargling 15-20 drops of normal saline will be administered to the patients 2 hours before the start of surgery and immediately before anesthesia (before prescribing any premed or pre-anesthetic medicine to the patient). The solution will have a suitable temperature for drinking (25°C). Gargling the solution will be done once for 30 seconds. The second intervention group: in this group, gargle 15-20 drops of the tincture of sage and marshmallow diluted in half a glass of water for patients 2 hours before surgery and immediately before anesthesia (before prescribing any Primed or pre-anesthetic medicine will be prescribed to the patient. The solution will have a suitable temperature for drinking (25 degrees Celsius). Gargling the solution will be done once and for 30 seconds. The sage plant and jasmine flower will be made into tincture form by an Iranian medical doctor, then 20-15 drops diluted in half a glass of water will be given to the patients. (based on the order of a doctor specializing in Iranian medicine). To prepare the tinctured herbal composition, an Iranian medical specialist made 50 grams of the sage plant (branches and flowers) along with 50 grams of marshmallow plant (roots, leaves, and flowers) in the form of a tincture (hydroalcoholic solution). And it will be combined with a ratio of 1 to 5 (1 for sage plant and marshmallow and 5 for hydroalcohol solution). 100 grams of plants will be kept in 500 grams of hydroalcoholic solution. This mixture is kept in a cool place for two weeks and then strained. We dilute 15 to 20 drops of the tinctured solution in half a glass of water and give it to the patient to gargle. Control group: Control group: In the control group, gargling 15-20 drops of distilled water as a placebo will be administered to the patients 2 hours before surgery and immediately before anesthesia (before prescribing any premed or pre-anesthetic medicine to the patient). All solutions will have a suitable temperature for drinking (25 degrees Celsius). Gargling the solutions will be done once for 30 seconds. Sore throat severity score based on VAS scale. Timepoint: before discharge from recovery and 6 hours later in the respective inpatient department. Method of measurement: Visual Analogue Scale. Percentage of people with sore throat. Timepoint: before discharge from recovery and 6 hours later in the respective inpatient department. Method of measurement: Assessment of the incidence of sore throat from the patient's own statements and observation and recording by a trained assistant of the researcher in the checklist. Cough incidence score in the scoring system designed by Harding and McVeigh. Timepoint: before discharge from recovery and 6 hours later in the respective inpatient department. Method of measurement: Harding and McVay scoring system. Hoarseness occurrence score in the scoring system designed by Harding and McVey. Timepoint: before discharge from recovery and 6 hours later in the respective inpatient department. Method of measurement: Harding and McVay scoring system. Esfahan University of Medical Sciences Approved 2023-06-26 Ethical Committee of Isfahan University of Medical Sciences Hezar Jerib Avenue, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)