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IRCT20160307026950N85 IRCT 2026-08-01 Esfahan University of Medical Sciences Comparison of Preventive Strategies for Postoperative Sore Throat Comparing the Effectiveness of Ginger Tea Gargling with Ketamine Gargling in Preventing Postoperative Sore Throat in Patients Under General Anesthesia with Endotracheal Intubation 2026-09-23 anticipated 15 Pending https://irct.ir/trial/92020 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, 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, 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 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. 3 sore throat. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Yes - There is a plan to make this available What will be shared: The main outcome information will be shared after being de-identified When: Access period begins 6 months after results are published To whom: Employees in public and private scientific institutions Conditions: Analysis on the data is not allowed Where to obtain: Behzad Nazim Al-Raaya with email behzad_nazem@med.mui.ac.ir How to obtain: Immediately upon request Comments:
public Behzad Nazemroaya
Hezarjirib st, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3212 3543 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences scientific Behzad Nazemroaya
Hezarjirib st, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3212 3543 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Both Allergy to ginger or ketamine emergency surgery body mass index (BMI) >35 kg/m² surgery lasting more than 3 hours R07.0 Pain in throat Prevention Prevention Placebo 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. 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. 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. 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). Esfahan University of Medical Sciences Approved 2026-07-08 Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib street, Azadi square, Isfahan Isfahan Isfehan Iran (Islamic Republic of)