Effect of Hyaluronic Acid on Post-Intubation Sore Throat and Hoarseness in Breast Cancer Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Postoperative Sore Throat
研究概览
简要总结
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
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Endogra Gel Group
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.
干预措施: Endotra Gel (Device)
No Gel Group
Participants will receive standard care for endotracheal intubation under general anesthesia without application of any gel or lubricant to the endotracheal tube.
结局指标
主要结局
Incidence and Severity of Postoperative Sore Throat
时间窗: 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.
次要结局
- 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))
研究者
Jung-Pil Yoon
Clinical Assistant Professor
Pusan National University Yangsan Hospital