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

NCT ID: NCT07040631

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-02-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Endogra Gel Group

Participants will receive general anesthesia for breast cancer surgery. Endotra Gel, a hyaluronic acid-based gel, will be applied evenly on the surface of the endotracheal tube cuff prior to intubation.

Group Type: EXPERIMENTAL

Endotra Gel

Intervention Type: DEVICE

Endotra 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.

No Gel Group

Participants will receive standard care for endotracheal intubation under general anesthesia without application of any gel or lubricant to the endotracheal tube.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Endotra Gel

Endotra 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

21-2025-006

Identifier Type: -

Identifier Source: org_study_id