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

Pusan National University Yangsan Hospital

Status: Not yet enrolling

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

Treatments: Device: Endotra Gel

Study type: Interventional

Funder types: Other

Identifiers

NCT07040631

21-2025-006

Details and patient eligibility

About

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.

Enrollment: 92 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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92 participants in 2 patient groups

Endogra Gel Group

Experimental group

Description:

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.

Treatment:

Device: Endotra Gel

No Gel Group

No Intervention group

Description:

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