Comparing the Effectiveness of Ginger Tea Gargling with Ketamine Gargling in Preventing Postoperative Sore Throat in Patients Under General Anesthesia with Endotracheal Intubation
To compare the effectiveness of ginger tea gargle and ketamine gargle in preventing and reducing the severity of postoperative sore throat in patients undergoing general anesthesia with endotracheal intubation.
Secondary objectives:
To compare the severity of postoperative sore throat.
To compare the incidence of postoperative sore throat among the study groups.
Design
A randomized, controlled, double-blind, three-arm parallel clinical trial will be conducted in patients undergoing elective surgery. Participants will be randomly allocated to ginger tea gargle, ketamine gargle, and control groups using block randomization with a block size of six. The study will include 150 participants. This trial will be conducted as a phase 3 clinical trial.
Settings and conduct
Patients undergoing elective surgery under general anesthesia with endotracheal intubation will be randomly assigned to three groups (ginger, ketamine, and control) after informed consent. The solutions will be prepared in coded bottles, and participants and outcome assessors will be blinded to group allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients undergoing elective surgery under general anesthesia requiring endotracheal intubation for more than 30 minutes.
(ASA) physical status I–II.
provision of written informed consent.
Exclusion criteria:
History of allergy to ginger or ketamine.
presence of underlying throat-related conditions.
emergency surgery.
body mass index (BMI) >35 kg/m².
operative duration exceeding 3 hours.
Intervention groups
ginger tea gargle group, ketamine gargle group, and control group
Main outcome variables
Incidence of postoperative sore throat; severity of postoperative sore throat at different assessment time points; comparison of the effectiveness of ginger tea gargle and ketamine gargle in reducing sore throat after endotracheal intubation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N85
Registration date:2026-08-01, 1405/05/10
Registration timing:prospective
Last update:2026-08-01, 1405/05/10
Update count:0
Registration date
2026-08-01, 1405/05/10
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 3543
Email address
behzad_nazem@med.mui.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-09-23, 1405/07/01
Expected recruitment end date
2027-05-22, 1406/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Ginger Tea Gargling with Ketamine Gargling in Preventing Postoperative Sore Throat in Patients Under General Anesthesia with Endotracheal Intubation
Public title
Comparison of Preventive Strategies for Postoperative Sore Throat
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Written informed consent obtained
absence of underlying throat-related conditions (e.g., severe gastroesophageal reflux disease [GERD] or respiratory tract infection)
Patients with American Society of Anesthesiologists (ASA) physical status I–II
Patients undergoing elective surgical procedures (e.g., cholecystectomy, hernia repair, or thyroidectomy) requiring endotracheal intubation for a duration exceeding 30 minutes
Exclusion criteria:
Allergy to ginger or ketamine
emergency surgery
body mass index (BMI) >35 kg/m²
surgery lasting more than 3 hours
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation sequence will be generated using block randomization with a fixed block size of 6, with an allocation ratio of 1:1:1 to the ginger, ketamine, and control groups. The randomization sequence will be generated using the online Sealed Envelope Randomization Service. The generated sequence will be used sequentially for participant allocation. The randomization list will be prepared and maintained by an individual independent of the outcome assessors, and group allocation will remain concealed from the patients and outcome assessors until completion of the intervention and outcome assessment.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be conducted using a double-blind design. Participants will be blinded to the type of intervention received (ginger tea gargle, ketamine gargle, or control solution). All solutions will be prepared by the hospital pharmacist in identical, coded bottles to ensure that the interventions are indistinguishable.
Outcome assessors (recovery room nurses or interns) responsible for evaluating postoperative sore throat will be blinded to group allocation. Healthcare personnel involved in routine postoperative care will remain unaware of treatment allocation whenever they do not require access to the randomization codes.
The principal investigator and research team members involved in data collection and analysis will not have access to the allocation codes until completion of data collection and initial analyses. The randomization codes will be revealed only after completion of the planned analyses.
Data analysts will analyze coded data without knowledge of intervention assignments whenever feasible. Members of the Data Safety Monitoring Committee (if applicable) and individuals involved in manuscript preparation will remain blinded to group allocation unless access to this information is required.
Placebo
Used
Assignment
Parallel
Other design features
This study is designed as a prospective, randomized, controlled, double-blind, three-arm parallel clinical trial. Participants will be randomly allocated to three parallel groups using block randomization with a block size of six: ginger tea gargle, ketamine gargle, and control groups. To maintain blinding, all solutions will be prepared by the hospital pharmacist in identical, coded bottles. Participants and outcome assessors (recovery room nurses or interns) will be blinded to group allocation. The incidence and severity of postoperative sore throat following endotracheal intubation will be assessed at predefined time points and compared among the groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Azadi square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2026-07-08, 1405/04/17
Ethics committee reference number
IR.MUI.MED.REC.1405.154
Health conditions studied
1
Description of health condition studied
sore throat
ICD-10 code
R07.0
ICD-10 code description
Pain in throat
Primary outcomes
1
Description
Severity of postoperative sore throat (POST) following endotracheal intubation, measured using the visual analog scale (VAS: 0–10)
Timepoint
Assessment of postoperative sore throat (POST) severity using the visual analog scale (VAS: 0–10) at 2, 6, and 24 hours after surgery.
Method of measurement
Visual Analogue Scale for assessment of postoperative sore throat severity, consisting of a 10-centimeter line scored from zero (no sore throat) to 10 (the worst imaginable sore throat).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving ginger tea gargle solution according to the study protocol before surgery; the solution is prepared in identical coded bottles and administered by gargling.
Category
Prevention
2
Description
Intervention group: Receiving ketamine gargle solution according to the study protocol before surgery; the solution is prepared in identical coded bottles and administered by gargling.
Category
Prevention
3
Description
Control group: Receiving a control solution (placebo) similar to the intervention solutions, without the active ingredient, prepared in identical coded bottles; administered according to the study protocol before surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahara hospital
Full name of responsible person
Behzad Nazemroaya
Street address
Soffeh boulivard, Shahid Kesari highway
City
isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
7346181764
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Behzad Nazemroaya
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjirib st, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3212 3543
Fax
+98 31 3669 1510
Email
behzad_nazem@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemroaya
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjirib st, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3212 3543
Fax
+98 31 3669 1510
Email
behzad_nazem@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemroaya
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjirib st, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3212 3543
Fax
+98 31 3669 1510
Email
behzad_nazem@med.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
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The main outcome information will be shared after being de-identified
When the data will become available and for how long
Access period begins 6 months after results are published
To whom data/document is available
Employees in public and private scientific institutions
Under which criteria data/document could be used
Analysis on the data is not allowed
From where data/document is obtainable
Behzad Nazim Al-Raaya with email behzad_nazem@med.mui.ac.ir
What processes are involved for a request to access data/document