Hyaluronic Acid for Prevention of Post-Intubation Sore Throat and Hoarseness

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer; Postoperative Sore Throat, Cough, Hoarseness; Endotracheal Intubation; General Anesthesia

• Registration Number: NCT07040631
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-20
• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted QC: 2025-06-24
• Last Update Submitted: 2025-06-24
• Study First Posted: 2025-06-27
• Last Update Posted: 2025-06-27
• Primary Completion: 2026-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Refusal to provide informed consent
• Determined to be unsuitable for study participation by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence and Severity of Postoperative Sore Throat	Up to 1 hour after extubation at PACU	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.

Secondary Outcome Measures

Name	Time	Method
Incidence and Severity of Postoperative Hoarseness	Up to 1 hour after extubation at PACU and on postoperative day 1 (within 24 hours after surgery)	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	Up to 1 hour after extubation at PACU and on postoperative day 1 (within 24 hours after surgery)	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	On postoperative day 1 (within 24 hours after surgery)	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.