Benzydamine spray to prevent postoperative sore throat after LMA use

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study randomizes 106 women undergoing gynecologic surgery with general anesthesia and LMA to receive either Difflam Forte throat spray or usual care in the post-anesthesia period. The goal is to see if benzydamine hydrochloride reduces the incidence or severity of postoperative sore throat (POST). Perioperative data are collected, and treatment is applied when patients are awake in the PACU. The trial addresses a common and bothersome postoperative issue linked to airway instrumentation and mucosal injury. Safety and feasibility in this specific surgical population are also evaluated.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. American Society of Anaesthesiologists (ASA) physical status 1-2
2. Female patients having laryngeal mask airway (LMA) for airway management for surgery in KKH;
3. BMI \< 40 kg/m2.

Exclusion Criteria:

1. Pregnant;
2. Pre-existing sore throat, or history of upper respiratory tract infection/ abnormalities, hypertension, chronic pain or anti-inflammatory drugs and antihypertensive treatment;
3. Allergies to benzydamine hydrochloride;
4. Symptomatic hiatus hernia;
5. Severe gastroesophageal reflux disease;
6. Contraindications to the use of LMA.

Where it's running

• KK Women's and Children's Hospital
  Singapore, Singapore Recruiting

Study contacts

• Principal investigator: Ban Leong Sng — KK Women's and Children's Hospital
• Study coordinator: Ban Leong Sng
• Email: sng.ban.leong@singhealth.com.sg
• Phone: +65 6394 1077

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.