To determine and compare the incidence and severity of post-anesthetic sore throat in the recovery room after full consciousness, as well as at 6 and 24 hours following extubation, between the intervention and control groups.
Design
This study will be conducted as a randomized double-blind clinical trial. The intervention group will receive intravenous hydrocortisone at a dose of 1.5 mg/kg before induction of anesthesia, while the control group will receive normal saline. The severity of postoperative sore throat will be assessed and recorded using the Visual Analog Scale (VAS) upon admission to the recovery room and at 6 and 24 hours after tracheal extubation.
Settings and conduct
A randomized double-blind parallel-group controlled clinical trial
Participants/Inclusion and exclusion criteria
participants:Patients scheduled for general anesthesia and endotracheal intubation .Inclusion criteria :Patient consent,age 18 to 65 yearswithout underlying disease .Exclusion criteria: Hypersensitivity to hydrocortisone,difficulty in intubation,history of chronic sore throat,recent upper respiratory tract infection.
Intervention groups
Intervention group:Participants will receive intravenous hydrocortisone at a dose of 1.5 mg/kg diluted in a 10-cc syringe administered as an intravenous infusion over 10 minutes before induction of general anesthesia.Control group:Participants will receive 10 cc of normal saline administered as an intravenous infusion over 10 minutes before induction of general anesthesia.
Main outcome variables
Severity of postoperative sore throat measured using the Visual Analog Scale (VAS) upon admission to the recovery room and at 6 and 24 hours after tracheal extubation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251231068511N1
Registration date:2026-07-21, 1405/04/30
Registration timing:retrospective
Last update:2026-07-21, 1405/04/30
Update count:0
Registration date
2026-07-21, 1405/04/30
Registrant information
Name
Sare Raeisi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3322 8409
Email address
sare4884@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-06-04, 1405/03/14
Expected recruitment end date
2026-07-20, 1405/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Intravenous Hydrocortison Administration on post-Anesthesi General Sore Throat
Public title
Evaluation of The Effeect of Intravenous Hydrocortisone Administration on posst-Anesthesia General Sore Throat
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patıent must be wıllıng to partıcıpate ın the study
The patıent must be between 18 and 65 years old
no underlyıng condıtıon
The patient must be candidate for general anesthesia
Exclusion criteria:
Drug allergy to Hydrocortıson
Multıpple attempts at ıntubatıon
Hıstory of chronıc sore throat
Hıstory of recent Upper Respıratory Tract Infectıon
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to the intervention or control group using simple randomization. Randomization will be performed using a random number table until the required sample size for each group is reached. Even numbers will be assigned to the hydrocortisone intervention group, and odd numbers will be assigned to the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted as a double-blind trial, where both the participants and the outcome assessor are blinded to the treatment allocation. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes (SNOSE). The randomization sequence will be generated first; then, the allocation will be written on a card and placed inside each envelope in the generated order. The envelopes will be numbered sequentially on the outside and placed in a box. Upon enrollment, each participant will receive the next available envelope in the sequence to determine their treatment assignment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Persian Gulf Boulevard, Dr.Hesabi Square University of Medical Sciences Campus, Central Headquarters Building, Second Floor.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2025-02-08, 1403/11/20
Ethics committee reference number
IR.ZAUMS.REC.1403.450
Health conditions studied
1
Description of health condition studied
Evaluation of the Effect of Intravenous Hydrocortisone Administration on Postoperative Sore Throat Following General Anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severıty score of postoperatıve sore throat followıng tracheal extubatıon after general anesthesıa
Timepoint
Assessment of postoperatıve sore throat severıty upon admıssıon to the recovery room ,and at 6 and 24 hours after tracheal extubation
Method of measurement
Based on the Visual Analugue Scale pain scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervantion group:Participants in this group will receive intravenous hydrocortisone at a dose of 1.5 mg/kg diluted in a 10-cc syringe administered as an intravenous infusion over 10 minutes before induction of general anesthesia.
Category
Prevention
2
Description
Control group: Participants in this group will receive 10 cc of normal saline administered as an intravenous infusion over 10 minutes before induction of general anesthesia.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ibn Abitaleb hospital and Khatam Al-Anbia hospital
Full name of responsible person
Asadullah Shakeri
Street address
Persian Gulf Highway,opposite Imam Khomeini Mosque, Ali ibn Abi Taleb hospital.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
info@zaums.ac.ir
Web page address
http://zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Saeideh Sarhaddi
Street address
Persian Gulf Boulevard, Dr. Hesabi Square, University of Medical Sciences Campus, Building No. 1, Second Floor
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 915 190 4706
Email
info@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Sareh Raeisi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Persian Gulf Boulevard, Dr. Hesabi Square, University of Medical Sciences Campus,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9914787697
Phone
+98 915 952 2512
Email
sare4884@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sareh Raeisi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practıtıoner
Street address
Second Floor,Central Headquarters Building,Univercity of Medical Sciences Campus,Dr.Hesabi Square,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2113
Email
sare4884@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sareh Raeisi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Second Floor,Central Headquarters Building,Univercity of Medical Sciences Campus,Dr.Hesabi Square,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 915 952 2512
Email
sare4884@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
Undecided - It is not yet known if there will be a plan to make this available