Comparison of the effect of licorice extract, ketamine and magnesium sulfate on gargling before laryngoscopy and endotracheal intubation in the prevention of sore throat, hoarseness and cough
Evaluation effect of licorice extract, ketamine and magnesium sulfate on gargling before laryngoscopy and endotracheal intubation in the prevention of sore throat, hoarseness and cough
Design
The study will be double blind and clinical trial.105 patients will be randomly divided into 3 groups. The groups are parallel. The trial phase is 3
Settings and conduct
Patients candidate for general anesthesia in valiasr Hospital in Arak are divided into 3 groups by simple randomization with blocks.The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: no history of drug use; no upper airway infection and cold; no mallampati more than 2; lack of liver and kidney failure; no need to use NG-tube during surgery and up to 24 hours after surgery; the duration of surgery should not be less than 45 minutes and not more than 120 minutes
Exclusion criteria:Patient dissatisfaction to continue attending the study; observing blood during suctioning when the endotracheal tube is removed; for any reason, we have to do laryngoscopy twice in the patient; history of heart disease and high blood pressure
Intervention groups
First intervention group: 0.5 milligram in kilogram Ketamine with 100 milligram of lidocaine and 10 millilitre of 20% dextrose will gargle.
Second intervention group: 0.5 geram (500 milligram)licorice powder dissolved in distilled water by volume (5 millilitre) with 100 milligram lidocaine and 10 ml dextrose 20% gargle Will do.
Third intervention group: 2 gram of magnesium sulfate along with 100 milligram of lidocaine and 10 millilitre of dextrose will gargle 20%.
Main outcome variables
Sore throat, cough, hoarseness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N170
Registration date:2021-12-18, 1400/09/27
Registration timing:prospective
Last update:2021-12-18, 1400/09/27
Update count:0
Registration date
2021-12-18, 1400/09/27
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2023-01-05, 1401/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of licorice extract, ketamine and magnesium sulfate on gargling before laryngoscopy and endotracheal intubation in the prevention of sore throat, hoarseness and cough
Public title
Comparison of the effect of licorice extract, ketamine and magnesium sulfate on gargling before laryngoscopy and endotracheal intubation in the prevention of sore throat, hoarseness and cough
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
30 to 60 years
ASA class I and II
No history of sore throat before surgery
No history of head and neck surgery, especially throat
No history of drug use
No history of chronic housing use
Hypersensitivity to the drugs used in this study
No upper airway infection and cold
No mallampati more than 2
Lack of liver and kidney failure
No need to use NG-tube during surgery and up to 24 hours after surgery
The duration of surgery should not be less than 45 minutes and not more than 120 minutes
Exclusion criteria:
Patient dissatisfaction to continue attending the study
Observing blood during suctioning when the endotracheal tube is removed
For any reason, we have to do laryngoscopy twice in the patient
History of heart disease and high blood pressure
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 3 groups using a permuted balanced block randomization method with the size of blocks 3 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
It is a double-blind study. Analysts, evaluators, and participants are unaware of the grouping.The intern is unaware of the drugs prescribed in each group and the anesthesiologist prepares the drugs and provides them to the intern, and the patients are not aware of their group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-09-29, 1400/07/07
Ethics committee reference number
IR.ARAKMU.REC.1400.167
Health conditions studied
1
Description of health condition studied
General anesthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia
Primary outcomes
1
Description
Sore throat
Timepoint
In recovery, 2, 4, 8, 12 and 24 hours after surgery
Method of measurement
Visual Pain Questionnaire
2
Description
Cough
Timepoint
In recovery, 2, 4, 8, 12 and 24 hours after surgery
Method of measurement
Physical examination
3
Description
hoarseness
Timepoint
In recovery, 2, 4, 8, 12 and 24 hours after surgery
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: 0.5 milligram in kilogram Ketamine German company Rotex Medica, importer of Pan Pharma Therapeutic Drug Finder) with 100 milligram of lidocaine ( Caspian Tamin Rasht - Iran) and 10 milliliter of 20% dextrose (Shahid Ghazi Pharmaceutical Company - Tabriz) will gargle.
Category
Treatment - Drugs
2
Description
Second intervention group: 0.5 geram (500 milligram)licorice powder dissolved in distilled water by volume (5 millilitre) with 100 milligram lidocaine and 10 ml dextrose 20% gargle Will do.
Category
Treatment - Drugs
3
Description
Third intervention group: 2 gram of magnesium sulfate (50% made by Shahid Ghazi Pharmaceutical Company - Iran Tabriz) along with 100 milligram of lidocaine and 10 milliliter of dextrose will gargle 20%.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Hesamodin Modir
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
modir.he@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Behnam Mahmodie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
mahmodie@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamedin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street