Breast CancerNCT07040631
Hyaluronic Acid for Prevention of Post-Intubation Sore Throat and Hoarseness
A study testing Endotra Gel in people with Breast Cancer and Postoperative Sore Throat, Cough, Hoarseness, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Breast Cancer, Postoperative Sore Throat, Cough, Hoarseness, Endotracheal Intubation
- What is being tested?
- Endotra Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Aug 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Pusan national university yangsan hospital
Yangsan, Gyeongsangnam-do, 50612
About this study
Official title: Effect of Hyaluronic Acid on Post-Intubation Sore Throat and Hoarseness in Breast Cancer Surgery: A Randomized Controlled Trial
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.
Read more
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
- Being tested
- Endotra Gel
- Keywords
- Postoperative Sore Throat, Hyaluronic Acid, Lubricating Gel, Endotracheal Intubation, hoarseness, breast cancer surgery, randomized controlled trial
- Medical subject headings
- Breast Neoplasms, Cough, Hoarseness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotra GelDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 hour after extubation at PACU
Secondary outcomes (3)
Incidence and Severity of Postoperative Hoarseness
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.
Measured: Up to 1 hour after extubation at PACU and on postoperative day 1 (within 24 hours after surgery)
Incidence and Severity of Postoperative Cough
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.
Measured: Up to 1 hour after extubation at PACU and on postoperative day 1 (within 24 hours after surgery)
Patient Satisfaction with Intubation Experience
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.
Measured: On postoperative day 1 (within 24 hours after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start6 Aug 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Pil Yoon, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040631
- Sponsor's protocol ID
- 21-2025-006
- Status last verified
- Jul 2026
- First submitted
- 20 May 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyaluronic Acid on Post-Intubation Sore Throat and Hoarseness in Breast Cancer Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07040631
- Acronym / sponsor ID
- 21-2025-006
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endogra Gel Group | Experimental | Device: Endotra GelParticipants 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. |
| 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. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endotra GelEndotra 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. | Device | Endogra Gel Group |
Primary outcome
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.
3 secondary outcomes
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)
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)
Patient Satisfaction with Intubation Experience
Time frame: On postoperative day 1 (within 24 hours after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotra Gel in people with Breast Cancer and Postoperative Sore Throat, Cough, Hoarseness, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Postoperative Sore Throat (time frame: Up to 1 hour after extubation at PACU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.