The goal of this clinical trial is to find out whether applying Endotra Gel, a hyaluronic acid-based gel, to the endotracheal tube can help reduce sore throat and hoarseness after surgery.
These symptoms are common after general anesthesia when a endotracheal tube is placed into the trachea. They can cause discomfort and affect patient recovery.
The main questions this study aims to answer are:
* Does Endotra Gel reduce the chance of having a sore throat after surgery? * Does it help improve hoarseness or coughing after surgery?
Participants in this study will:
* Undergo general anesthesia for breast cancer surgery * Be randomly assigned to one of two groups:
* One group will receive Endotra Gel applied to the endotracheal tube before intubation * The other group will have standard care with no gel * Be monitored for sore throat, hoarseness, and coughing right after surgery and on the day after surgery * Answer questions about their symptoms and satisfaction with their recovery The results will help researchers learn whether using Endotra Gel during intubation can improve patient comfort and reduce airway irritation after surgery.
Adults aged 19 to 80 years
Scheduled to undergo breast cancer surgery under general anesthesia with endotracheal intubation
American Society of Anesthesiologists (ASA) physical status I to III
Mallampati classification of III or higher
Recent upper respiratory infection or symptoms of upper airway infection
Pre-existing laryngeal disease or chronic respiratory conditions (e.g., asthma, chronic bronchitis)
Current use of systemic steroids
Parallel
Endotra Gel
DeviceEndotra Gel is a hyaluronic acid-based, water-soluble wound dressing gel approved by the Korean Ministry of Food and Drug Safety. In this study, it is applied to the cuff of the endotracheal tube before intubation to evaluate its effect on reducing postoperative sore throat and hoarseness.
Incidence and Severity of Postoperative Sore Throat
Postoperative sore throat (POST) will be assessed using a standardized 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) through direct patient interview. Assessment will be performed by blinded outcome assessors.
Incidence and Severity of Postoperative Hoarseness
Hoarseness will be evaluated using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) through patient interview. Evaluation will be performed by blinded assessors.
Incidence and Severity of Postoperative Cough
Postoperative cough will be assessed on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) through direct questioning. Evaluation will be conducted by blinded assessors.
Patient Satisfaction with Intubation Experience
Patient satisfaction regarding intubation-related discomfort will be evaluated using two structured questions: "Postoperative discomfort related to intubation interfered with daily life." "Overall, I am satisfied with the intubation experience." Each item will be rated on a 5-point Likert scale: 1 = Strongly agree, 2 = Agree, 3 = Neutral, 4 = Disagree, 5 = Strongly disagree. Responses will be collected on postoperative day 1 and analyzed as ordinal variables.
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