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Completed

NCT Number: NCT07040631

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cough Endotracheal Intubation General Anesthesia Hoarseness Laryngeal Diseases Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Postoperative Sore Throat, Cough, Hoarseness Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Skin Diseases Skin and Connective Tissue Diseases Voice Disorders

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan national university yangsan hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endotra Gel

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.

Primary outcomes

  1. Incidence and Severity of Postoperative Sore Throat

    Time frame: 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 outcomes

  1. Incidence and Severity of Postoperative Hoarseness

    Time frame: 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.

  2. Incidence and Severity of Postoperative Cough

    Time frame: 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.

  3. Patient Satisfaction with Intubation Experience

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

Effect of Hyaluronic Acid on Post-Intubation Sore Throat and Hoarseness in Breast Cancer Surgery: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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