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
We want to assess the effect of Rosemary gargle versus Lidocaine gargle to find a prophylactic treatment that has high effect on sore throat and voice violence after intubation and also has less side effect
Design
Randomized, triple blind clinical trial with 1 control group and 2 intervention groups and phase 3 study of 90 patients.
We use Random allocation app to randomize the study.
Settings and conduct
Before intubation and preemptively, 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 with surgical mesh 2-3 minutes before general anesthesia,
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 with surgical mesh 2-3 minutes before general anesthesia. In group3 we will give gargle of 30 drops of distilled water with surgical mesh 2-3 minutes before general anesthesia. Research place : Hospitals of Isfahan university of medical sciences (Alzahra and Kashani hospitals).
Participants/Inclusion and exclusion criteria
Inclusion criteria: candidate patients for surgery; ASA 1,2; age between 18 to 65 years old; informed consent of patient.
Non -inclusion criteria: IV or opioid addicts; previous allergy to this research,s drugs; Heart, Renal or Hepatic failure patients; hard intubation (Grade 4 or upper); malformation of airway tract.
Intervention groups
We have 3 intervention groups. In group 1 we will administer Rosemary gargle; group 2 Lidocaine gragle and group 3: distilled water gargle.
Main outcome variables
Voice violence; sore throat
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101211005362N29
Registration date:2022-02-26, 1400/12/07
Registration timing:registered_while_recruiting
Last update:2022-02-26, 1400/12/07
Update count:0
Registration date
2022-02-26, 1400/12/07
Registrant information
Name
Mohammadreza Safavi
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1273 2659
Email address
safavi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Comparison between Rosemary gargle versus Lidocaine gargle on sore throat and voice violence after endotracheal intubation under general anesthesia in candidates patients for surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patient for surgery
ASA 1,2
Age between 18 to 65 years old
Informed consent of patient
Exclusion criteria:
ِ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
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib street, Azadi square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-11-04, 1400/08/13
Ethics committee reference number
IR.MUI.MED.REC.1400.621
Health conditions studied
1
Description of health condition studied
Sore throat
ICD-10 code
R07.0
ICD-10 code description
Pain in throat
2
Description of health condition studied
Hoarseness
ICD-10 code
R49
ICD-10 code description
Voice and resonance disorders
Primary outcomes
1
Description
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
2
Description
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
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
3
Description
Control group: In this group we will give gargle of 30 drops of distilled water 2-3 minutes with surgical mesh before general anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr. Mohammadreza Safavi Homami
Street address
Soffe blvd., Kharrazi highway
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Fax
+98 31 3669 1510
Email
alzahra@mui.ac.ir
Web page address
https://alzahra.mui.ac.ir/
2
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Dr. Mohammadreza Safavi Homami
Street address
Kharrazi highway,Beheshti blvd,Kashani street
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
kashani@mui.ac.ir
Web page address
https://kashani.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mansoor Siavash Dastjerdi
Street address
Hezar Jerib street, Azadi square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Fax
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
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
Dr. Mohammadreza Safavi Homami
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jerib street, Azadi square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
009836683221
Email
safavi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Safavi Homami
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jerib street, Azadi square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 3221
Email
www.safavi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Safavi Homami
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jerib street, Azadi square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 3221
Email
www.safavi@med.mui.ac.ir
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
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available