Comparative study of the preventive effect of two different doses of intra-cuff dexamethasone on sore throat after tracheal tube removal in patients undergoing cesarean section in Beheshti Hospital in Esfahan.
Comparison of the effect of two doses of intra-cuff dexamethasone on sore throat after tracheal tube removal in patients undergoing cesarean section
Design
A clinical trial with a control group and 2 three-way blinded and randomized intervention groups designed for 96 patients, which will be conducted between July and October 2024.
Settings and conduct
This study will be conducted under the supervision of the anesthesia department at Shahid Beheshti Hospital in Isfahan. Patients are studied in three groups. Anesthesia conditions are the same in all patients. After umbilical cord clamping, 1 cc of dexamethasone were given to the first group and 2 cc of it given tosecond group and 2 cc of normal saline to the third group. After entering recovery, the severity of sore throat is measured through VAS by a person unaware of the study in three groups. The patient and the person who evaluates the severity of the sore throat do not know the type and amount of the injected substance.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Age between 20-40 y/o, Candidate for elective cesarean section; Candidate for general anesthesia. Non-entry criteria : Spinal anesthesia; Uncontrolled heart disease; Uncontrolled blood pressure; History of asthma, allergy: Current common cold; History of allergy to medication used in our study; Smoking and drug abuse.
Intervention groups
Intervention group: 1 cc of dexamethasone solution plus 1 cc of normal saline is injected into the cuff. 2 cc of dexamethasone solution was injected into the cuff of the second group of patients, and only 2 cc of normal saline was injected into the cuff of the third group (control group) and the rest of the cuff volume was filled with air until the pressure of 25 mm Hg was reached.
Main outcome variables
Duration of intubation - duration of extubation - severity of sore throat
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240430061610N1
Registration date:2024-06-14, 1403/03/25
Registration timing:registered_while_recruiting
Last update:2024-06-14, 1403/03/25
Update count:0
Registration date
2024-06-14, 1403/03/25
Registrant information
Name
Parna Panahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3628 5589
Email address
parnapnh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-14, 1403/03/25
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the preventive effect of two different doses of intra-cuff dexamethasone on sore throat after tracheal tube removal in patients undergoing cesarean section in Beheshti Hospital in Esfahan.
Public title
Effect of two doses of dexamethasone in sore throat after tracheal tube removal.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Be candidate for elective cesarean section
Be 20-40 years old
Be candidate for general anesthesia
Exclusion criteria:
Spinal anesthesia
History of sensitivity to the drugs used in the study
Uncontrolled heart disease, uncontrolled blood pressure
Current history of asthma, allergies, colds
use of drugs and cigarettes
Uncontrolled blood pressure
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method using randomization software and dividing patients into 3 groups of 32 people with this method
Blinding (investigator's opinion)
Triple blinded
Blinding description
It is explained to the participants that they will enter one of the 3 groups, but they cannot understand the dose and type of the substance during anesthesia. Also, the person who evaluates the severity of the sore throat does not know the type and dose of the substance.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Building No. 4, Research and Technology Vice-Chancellor, Isfahan University of Medical Sciences, Hazar Jarib St.
Sore throat - sore throat score of the patients based on vas questionnaire
Timepoint
0-6-12-18-24 hours after consciousness.
Method of measurement
Visual analogue scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Group1 :Group 1 cuffs are injected with 1 cc of dexamethasone solution (equivalent to 4 mg) plus 1 cc of normal saline, and the rest of the cuff volume is filled with air until a pressure of 25 mm Hg is reached.
Category
Treatment - Drugs
2
Description
Intervention group 2: 2 cc of dexamethasone solution (equivalent to 8 mg) is injected into the cuff of the second group of patients and the rest of the volume of the cuff is filled with air until a pressure of 25 mm Hg is reached.
Category
Treatment - Drugs
3
Description
Control group: only 2 cc of normal saline is injected into the cuff and the volume of the cuff is filled with air until a pressure of 25 mm Hg is reached.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Zahra Gholami
Street address
Isfahan Beheshti Hospital - Motahari St
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
vcr-office@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mozghan Mortazavi
Street address
Isfahan University of Medical Sciences, Hazar Jarib Street, Shiraz Gate
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
MojganMortazavi@gmail.com
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
Mitra Jabalameli
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Sciences, Hazar Jarib Street, Shiraz Gate
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
jabalameli@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mitra Jabalameli
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Sciences, Hazar Jarib Street, Shiraz Gate
City
Esfahan
Province
Isfehan
Postal code
8173763835
Phone
+98 31 3628 5589
Email
parnapanahi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parna Panahi
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Sciences, Hazar Jarib Street, Shiraz Gate
City
Esfahan
Province
Isfehan
Postal code
8173763835
Phone
+98 31 3628 5589
Email
parnapanahi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Participant Data File: All data can be shared after de-identifying individuals. The study protocol file can be shared after the end of the study. The statistical analysis map file can be shared after the end of the study. The informed consent form can be shared after the end of the study. The clinical study report can be shared after the end of the study.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions as well as those working in industry.
Under which criteria data/document could be used
The use of documents for conducting other research studies is allowed by mentioning the source.
From where data/document is obtainable
Dr. Mitra Jabal Ameli: jabalameli@med.mui.ac.ir Dr. Rihank Talakoub: talakoub@med.mui.ac.ir Parnapanahi parnapanahi@gmail.com
What processes are involved for a request to access data/document
First, the applicant states his request by sending an email, while introducing himself and the purpose of receiving information, and after checking the validity of his request, the information will be provided to him.