General Objective:To evaluate the effect of intravenous administration of methylprednisolone on postoperative sore throat following general anesthesia in Ali Ibn Abi Talib and Khatam al-Anbia Hospitals, Zahedan.
Design
This Phase III randomized, triple-blind, parallel clinical trial will be conducted.
100 patients undergoing general anesthesia will be randomly assigned (1:1) to intervention and control groups using the RAND function in Excel.
Settings and conduct
This triple-blind randomized clinical trial aims to reduce postoperative sore throat after general anesthesia at Ali Ibn Abi Talib and Khatam al-Anbia Hospitals, Zahedan.Patients will be randomly assigned (1:1) by block randomization to either the methylprednisolone or placebo group.Allocation concealment will be ensured using sealed opaque envelopes.
Participants/Inclusion and exclusion criteria
Patients aged 18–65 who give informed consent and have no underlying disease, immunodeficiency, or methylprednisolone allergy will be included.Those with chronic sore throat, recent upper respiratory infection, or osteoporosis will be excluded.Uncooperative patients or those requiring multiple intubation attempts will also be withdrawn.
Intervention groups
In the intervention group, prior to induction of anesthesia, patients will receive Methylprednisolone succinate (manufactured by Jaber Ibn Hayyan Pharmaceutical Company) at a dose of 3 mg/kg, infused intravenously over 10 minutes using a 10-mL syringe.
Main outcome variables
Reduction of inflammation and pain, quality of postoperative care and patient satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251007067539N1
Registration date:2025-10-12, 1404/07/20
Registration timing:prospective
Last update:2025-10-12, 1404/07/20
Update count:0
Registration date
2025-10-12, 1404/07/20
Registrant information
Name
Sadaf Jalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 992 841 5720
Email address
sadafjalili111@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-23, 1404/08/01
Expected recruitment end date
2026-03-17, 1404/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Intravenous Methylprednisolone Injection on Sore Throat Caused by General Anesthesia
Public title
Evaluation of the Effect of Intravenous Methylprednisolone Injection on Sore Throat Caused by General Anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient provides informed consent to participate in the study
The patient's age is between 18 and 65 years.
The patient has no known hypersensitivity to methylprednisolone.
The patient has no underlying medical conditions
The patient does not have any immunodeficiency disorders.
Exclusion criteria:
Known drug hypersensitivity to methylprednisolone.
Lack of patient cooperation during the study.
History of chronic sore throat.
Recent history of upper respiratory tract infection.
History of osteoporosis.
Multiple attempts at tracheal intubation.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to either the intervention or control group using a block randomization method with an equal allocation ratio (1:1). The randomization sequence will be generated by computer software and kept confidential. To ensure allocation concealment, the sequences will be placed in opaque, sealed, and sequentially numbered envelopes. Each patient who meets the inclusion criteria will select one envelope in order of enrollment and, based on its contents, will be assigned to either the intervention group (receiving intravenous methylprednisolone) or the control group (receiving placebo)
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients will be randomly assigned to either the intervention or control group using a block randomization method with an equal allocation ratio (1:1). The randomization sequence will be generated by computer software and kept confidential. To ensure allocation concealment, the sequences will be placed in opaque, sealed, and sequentially numbered envelopes. Each patient who meets the inclusion criteria will select one envelope in order of enrollment and, based on its contents, will be assigned to either the intervention group (receiving intravenous methylprednisolone) or the control group (receiving placebo)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Dr. Hasabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2025-10-05, 1404/07/13
Ethics committee reference number
IR.ZAUMS.REC.1404.222
Health conditions studied
1
Description of health condition studied
Sore throat from general anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score
Timepoint
The Visual Analogue Scale(VAS) pain score will be recorded in both groups upon admission to the recovery room, 6 hours after extubation, and 24 hours after extubation.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, prior to induction of anesthesia, patients will receive Methylprednisolone succinate (manufactured by Jaber Ibn Hayyan Pharmaceutical Company) at a dose of 3 mg/kg, infused intravenously over 10 minutes using a 10-mL syringe.
Category
Treatment - Drugs
2
Description
Control group: In the control group, 10 mL of normal saline will be infused intravenously over 10 minutes prior to induction of anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ebn Abitaleb hospital
Full name of responsible person
Dr.Kaveh Ouraei Yazdani
Street address
Ali ebn Abitaleb, in front of Imam Khomeini Mosque, Persian Gulf Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
۹۸۱۶۷۴۳۱۱۱
Phone
+98 54 3329 5570
Fax
+98 54 1341 1252
Email
hospital.aliebneabitaleb@gmail.com
2
Recruitment center
Name of recruitment center
Khatam al-Anbia Hospital
Full name of responsible person
Dr.Amir Gorgij
Street address
At the beginning of Jam Jam Boulevard, Khatam al-Anbia (PBUH) Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733345
Phone
+98 54 3322 0501
Email
khatamhospital_zah@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Hassan Okati Aliabadi
Street address
Zahedan University of Medical Sciences, Dr. Hasabi Square, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
zaums.research@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
1
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
Sadaf jalili
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Zahedan University of Medical Sciences, Dr. Hasabi Square, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 992 841 5720
Email
sadafjalili111@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sadaf jalili
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Zahedan University of Medical Sciences, Dr. Hasabi Square, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 992 841 5720
Email
sadafjalili111@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sadaf Jalili
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Zahedan University of Medical Sciences, Dr. Hasabi Square, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 992 841 5720
Email
sadafjalili111@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