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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:
Participants in this study will:
Undergo general anesthesia for breast cancer surgery
Be randomly assigned to one of two groups:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1 hour after extubation at PACU and on postoperative day 1 (within 24 hours after surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003371 | Cough |
| D006685 | Hoarseness |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| 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. |
| 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. | On postoperative day 1 (within 24 hours after surgery) |
| D017437 |
| Skin and Connective Tissue Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |