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

NCT07040631 | Not Yet Recruiting

• 1 other identifier: 21-2025-006
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

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

Keywords

Postoperative Sore Throat; Hyaluronic Acid; Lubricating Gel; Endotracheal Intubation; hoarseness; breast cancer surgery; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 hour after extubation at PACU

Secondary Outcomes (3)

• Incidence and Severity of Postoperative Hoarseness

  Up to 1 hour after extubation at PACU and on postoperative day 1 (within 24 hours after surgery)

• Incidence and Severity of Postoperative Cough

  Up to 1 hour after extubation at PACU and on postoperative day 1 (within 24 hours after surgery)

• Patient Satisfaction with Intubation Experience

  On postoperative day 1 (within 24 hours after surgery)

Study Arms (2)

Endogra Gel Group

EXPERIMENTAL

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.

Device: Endotra Gel

No Gel Group

NO INTERVENTION

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

Interventions

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.

Endogra Gel Group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms; Cough; Hoarseness

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Voice Disorders; Laryngeal Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 27, 2025
• Study Start: June 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06