Which Mouth Rinse Works Better for Soothing Sore Throat After Breast Cancer Surgery: Benzydamine or Magnesium Sulphate?

Comparing the Efficacy of Benzydamine and Magnesium Sulphate Oral Gargle for Treating Postoperative Sore Throat in Patients Undergoing breast surgeries A phase 2 randomised study - nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088920

Enrollment

Registered

2025-06-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J958- Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified

Interventions

Intervention1: benzydamine oral gargle: Patients will gargle with 15 ml of 0.15% benzydamine hydrochloride solution for 30 seconds Control Intervention1: magnesium sulphate oral gargle: Patients will

Eligibility

Inclusion criteria

Inclusion criteria: Adult female patients aged more than 18 years. POST GRADE more than or equal to 2 within 48 hours after surgery. Patients Undergoing elective breast surgeries under general anaesthesia with endotracheal intubation complaints of sore throat. ASA classification 1 to 3

Exclusion criteria

Exclusion criteria: Patients having Known allergy to benzydamine or magnesium sulphate Asthmatic patients on steroid nebulisation. Patients with History of respiratory tract infection within 1 week before surgery. Patients with History of gastroesophageal reflux disease (GERD) or oral ulcers. Patients unable to perform oral gargling. Patient refusal patients who are not extubated at the end of surgery

Design outcomes

Primary

Measure	Time frame
To study the difference in proportion of patients with reduction in POST score less than 2 assessed by four point scale between Benzydamine and magnesium sulphate oral gargle.Timepoint: 6 hours after the intervention	—

Secondary

Measure	Time frame
To evaluate difference in the duration of effect of the intervention between benzydamine and magnesium sulphate oral gargle as defined by recurrence of POST grade 2 or more after an initial response to the intervention. To study the difference in proportion of patients with reduction in POST score less than 2 assessed by 4 point scale between Benzydamine and magnesium sulphate oral over 24 hours after the intervention. To evaluate the difference in proportion of patients with stinging sensation and nausea between benzydamine and magnesium over 24 hours after the gargle administrationTimepoint: Over 24 hours after the intervention	—

Measure

Time frame

To evaluate difference in the duration of effect of the intervention between benzydamine and magnesium sulphate oral gargle as defined by recurrence of POST grade 2 or more after an initial response to the intervention. To study the difference in proportion of patients with reduction in POST score less than 2 assessed by 4 point scale between Benzydamine and magnesium sulphate oral over 24 hours after the intervention. To evaluate the difference in proportion of patients with stinging sensation and nausea between benzydamine and magnesium over 24 hours after the gargle administrationTimepoint: Over 24 hours after the intervention

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Countries

India

Contacts

Public ContactVinoth kumar

cancer institute, adayar

hariesh86@gmail.com9840066898

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026