IRCT | 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.

Protocol summary

Study aim: Determining and comparing the effect of normal saline gargling and tinctured solution of sage and marshmallow plants on the occurrence of sore throat, cough, hoarseness and severity of sore throat after endotracheal intubation in patients under general anesthesia
Design: The clinical trial has a control group, with two parallel groups, three blind strains, randomized, phase 3 on 114 patients. A table of random numbers was used for randomization.
Settings and conduct: This research will be a three-blind clinical trial with three groups, which will be conducted on 114 (5) patients under general anesthesia. A table of random numbers will be used for randomization. The solutions will be prepared in opaque containers with the names A, B and C. Trained research assistants were blinded to the contents of the containers. Therefore, research assistants as well as patients and statistical analysts will be blinded to the groups (triple-blind).
Participants/Inclusion and exclusion criteria: • 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)
Intervention groups: In the first intervention group, gargling 15-20 drops of normal saline, in the second intervention group, gargling 15-20 drops of a tincture of sage and marshmallow diluted in half a glass of water, and in the control group, gargling 15-20 drops of distilled water as a placebo for the patients 2 hours before the start of surgery and immediately before anesthesia (before prescribing any premed or pre-anesthetic medicine to the patient).
Main outcome variables: Tinctured solution of Sage and Alcea Normal saline 0.9% Placebo

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20230627058595N1

Registration date: 2023-07-31, 1402/05/09

Registration timing: prospective

Last update: 2023-07-31, 1402/05/09

Update count: 0
Registration date: 2023-07-31, 1402/05/09

Registrant information: Name

Fatemeh Shahnazari

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 31 3792 7630

Email address

fati.shahnazari373@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-08-06, 1402/05/15
Expected recruitment end date: 2023-09-06, 1402/06/15
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: 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.

Public title: 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.
Purpose: Prevention
Inclusion/Exclusion criteria: Inclusion criteria:

• 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

Exclusion criteria:

• 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
Age: From 18 years old to 65 years old
Gender: Both

Phase

3

Groups that have been masked

Participant
Investigator
Data analyser

Sample size

Target sample size: 114

Randomization (investigator's opinion)

Randomized

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 (investigator's opinion)

Triple blinded

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).

Placebo

Used

Assignment

Parallel

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)

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethical Committee of Isfahan University of Medical Sciences

Street address

Hezar Jerib Avenue, Isfahan, Iran

City

Isfahan

Province

Isfehan

Postal code

8177769639
Approval date: 2023-06-26, 1402/04/05
Ethics committee reference number: IR.MUI.NUREMA.REC.1402.047

Health conditions studied

1

Description of health condition studied: Occurrence of sore throat, cough, hoarseness and throat severity
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description: 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

2

Description: 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

3

Description: 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

4

Description: 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

Secondary outcomes

empty

Intervention groups

1

Description: 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.
Category: Treatment - Drugs

2

Description: 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.
Category: Treatment - Drugs

3

Description: 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.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Al-Zahra Hospital

Full name of responsible person

Mehrdad Nowrozi

Street address

Aghareb parast Highway, Sofe Blvd, Isfahan, Iran

City

Isfahan

Province

Isfehan

Postal code

8174675731

Phone

+98 31 3822 0000

Email

fati.shahnazari373@gmail.com

Web page address

https://alzahra.mui.ac.ir

2

Recruitment center: Name of recruitment center

Ayatollah Kashani Hospital

Full name of responsible person

Mojtaba Rahimi

Street address

Ayatollah Kashani Street, Isfahan, Iran

City

Isfahan

Province

Isfehan

Postal code

8343481839

Phone

+98 31 3233 5030

Email

BBkeyfiatkashani@gmail.com

Web page address

https://kashani.mui.ac.ir/fa

1

Sponsor: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Dr. Gholamreza Asgari

Street address

Hezar Jerib street

City

Isfahan

Province

Isfehan

Postal code

8174673461

Phone

+98 31 3668 8138

Email

research@mui.ac.ir

Web page address

https://research.mui.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Esfahan University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Fatemeh Shahnazari

Position

Educator of Nursing and Midwifery Faculty

Latest degree

Master

Other areas of specialty/work

General Surgery

Street address

Esfahan, Nursing and Midwifery Faculty,Operating room department

City

Isfahan

Province

Isfehan

Postal code

8174673461

Phone

+98 31 3792 7630

Fax

Email

fati.shahnazari373@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Fatemeh Shahnazari

Position

Educator of Nursing and Midwifery Faculty

Latest degree

Master

Other areas of specialty/work

Nursery

Street address

Esfahan, Nursing and Midwifery Faculty,Operating room department

City

Isfahan

Province

Isfehan

Postal code

8174673461

Phone

+98 31 3792 7630

Fax

Email

fati.shahnazari373@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Fatemeh Shahnazari

Position

Educator of Nursing and Midwifery Faculty

Latest degree

Master

Other areas of specialty/work

Nursery

Street address

Isfahan, Nursing and Midwifery Faculty,Operating room department

City

Isfahan

Province

Isfehan

Postal code

8174673461

Phone

+98 31 3792 7630

Fax

Email

fati.shahnazari373@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Not applicable

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.