A Randomized Controlled Trial Comparing Different Models of Tracheal Tube for Thyroid Surgery in Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The incidence of postoperative sore throat
研究概览
简要总结
Objective:Compare whether the use of tracheal catheters of models 6.0 and 6.5 causes less sore throat in women after thyroid surgery compared with the traditional use of model 7.0 tracheal catheters.Methods: Investigators enrolled 180 female patients with American Society of Anesthesiologists (ASA) physical status I and III, aged 18-65 years, and scheduled for elective undergoing thyroid surgery with general anesthesia. The participants were randomly assigned into three groups(n=60 each group):Group A: Tracheal catheter group with an inner diameter of 6.0mm, Group B: Tracheal catheter group with an inner diameter of 6.5mm, Group C: Tracheal catheter group with an inner diameter of 7.0mm.The incidence and severity of postoperative sore throat were recorded in three groups at 1 h, 6 h, 24 h and 48 h after operation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Thyroid surgery should be performed under general anesthesia (GA) at an appropriate time;
- •ASA grade I-III;
- •Aged 18-65 years;
- •BMI less than 35Kg/m2
- •In line with ethics, patients voluntarily accept this experiment and sign informed consent.
排除标准
- •Reflux esophagitis, preoperative sore throat, chronic pharyngitis, preoperative hoarseness, use of anticoagulants or corticosteroids, high risk of reflux or aspiration, dysphagia, previous oral or pharyngeal surgical intervention, bleeding disorder, severe heart, lung, liver and kidney dysfunction
- •Upper respiratory tract infection occurred within 2 weeks before surgery
- •Unable to insert ET (no more than two intubations)
- •Patients with hoarseness or sore throat before surgery
- •Language communication, hearing impairment or brain dysfunction such as stroke, unable to communicate
结局指标
主要结局
The incidence of postoperative sore throat
时间窗: at 1 hour, 6 hour, 24 hour and 48 hour after operation
The incidence of postoperative sore throat
次要结局
未报告次要终点