Comparative study of the preemptive effect of two-different doses of intravenous dexamethasone on sore throat after caesarean section under general anesthesia
Comparative determination of the preemptive effect of two-different doses of intravenous dexamethasone on sore throat after caesarean section under general anesthesia
Design
A randomized, double blinded, sham controlled clinical trial with 2 parallel groups design of 90 patient, enrolled between october 2023 and january 2024
Settings and conduct
This study will be performed on anesthesia at Beheshti Hospital of Isfahan. The patients will be divided into three groups.Except injecting dexamethason, other conditions of anesthesia, remain consistent across all patients. Following the clamping of the umbilical cord, the first group will receive an injection of 8 mg dexamethasone, the second group will receive 4 mg dexamethasone, and the third group will receive 2 cc of normal saline. After surgery, the intensity of sore throat will be assessed. This assessment will be conducted by an individual unaware of the study details across the three groups. Both the patient and the evaluator of sore throat severity will be blinded to the type and quantity of the injected substance.
Participants/Inclusion and exclusion criteria
Entry requirements: 1. Pregnant women with ASA II older 18 years and with gestational age 37-42 weeks who are candidate for caesarean section under general anesthesia
2. Patient's Informed consent for participate in the research study
Non-entry conditions: 1. Patients who are sufĺfering from sore throat before anesthesia 2. Use of painkiller before surgery 3. Patients who have used corticosteroid during pregnancy 4. Patients who are allergic to the drug that is used in the research study 5. Difficult intubation
Intervention groups
First group will receive dexamethasone 8 mg; Second group will receive dexamethasone 4 mg; Third group will receve normal salin
Main outcome variables
duration of intubation; duration of extubation; intensity of sore throat; kind of intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230716058799N1
Registration date:2023-08-20, 1402/05/29
Registration timing:prospective
Last update:2023-08-20, 1402/05/29
Update count:0
Registration date
2023-08-20, 1402/05/29
Registrant information
Name
Fatemeh Dadvar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 9484
Email address
f.dadvar.ir@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-22, 1402/06/31
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the preemptive effect of two-different doses of intravenous dexamethasone on sore throat after caesarean section under general anesthesia
Public title
Comparative study of the preemptive effect of two-different doses of intravenous dexamethasone on sore throat after caesarean section under general anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with ASA (American Society of Anesthesiologists) II older 18 years and with gestational age 37-42 weeks who are candidate for caesarean section under general anesthesia
Patient's Informed consent for participate in the research study
Exclusion criteria:
Patients who are sufĺfering from a cold or sore throat before anesthesia
Patients with BMI more than 40
Use of painkiller and sedative drugs before surgery
Patients who have used corticosteroid during pregnancy
Patients who are allergic to the drug that is used in the research study
Patients who have asthma or lung disease in their past medical history
patients who have grade 3 or 4 in laryngoscopy grading (difficult intubation)
Age
From 18 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
We will explain to the participate that she will be entered one of the three groups; but she can't understand the dose and kind of substance that is used during anesthesia.
Also the person who will assessment the severity of sore throat, doesn't know the kind and dose of the substance.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences
Sore throat score base on VAS (Visual Analogue Scale)
Timepoint
The intensity of sore throat will be assessed at the first, 6th, 12th and 24th hours after tracheal tube removal
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group will receive an injection of 8 mg dexamethasone intravenous, after umbilical cord clamping
Category
Prevention
2
Description
Intervention group: The second group will receive an injection of 4 mg dexamethasone intravenous, after umbilical cord clamping
Category
Prevention
3
Description
Control group: The 3td group will receive an injection of 2cc normal salin intravenous, after umbilical cord clamping
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti hospital
Full name of responsible person
Mitra jabalameli
Street address
Alzahra hospital, Soffeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
+98 31 3668 4510
Email
Alzahra@mui.ac.ir
Web page address
http://www.Alzahra.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Hezarjerib Avenue
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3792 8134
Fax
+98 31 3668 8597
Email
vcr-office@med.mui.ac.ir
Web page address
https://med.mui.ac.ir
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
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Alzahra hospital, Soffeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
jabalameli@med.mui.ac.ir
Web page address
http://Alzahra.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mitra jabalameli
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Alzahra hospital, Soffeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
jabalameli@med.mui.ac.ir
Web page address
http://Alzahra.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mitra Jabalameli
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Alzahra hospital, Soffeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
F.dadvar.ir@gmail.com
Web page address
http://Alzahra.mui.ac.ir
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
Individual participant data: All data can be shared after Unidentifiable individuals.
Study protocol file can be shared after finishing the study.
Statistical analysis map file can be shared after finishing the study.
Informed consent form can be shared after finishing the study.
Clinical study report can be shared after finishing the study.
When the data will become available and for how long
Start access the information 6 month after Publication of results
To whom data/document is available
The data is available for researchers are working in academic Institutions and also the persons are working in industry.
Under which criteria data/document could be used
Using the data in other researches is Allowed after mention the source.
From where data/document is obtainable
Dr. Mitra Jabalameli: jabalameli@med.mui.ac.ir
Dr. Reyhanak Talakoub: talakoub@med.mui.ac.ir
Fatemeh Dadvar: f.dadvar.ir@gmail.com
What processes are involved for a request to access data/document
At the first, the applicant introduce herself/himself and mention the goal of recieving of the data by sending email. After proving the truth, the data will send for him/her.