NCT03885752Unknown1 期
The Effects of Preoperatively Chewing Gum on Sore Throat After General Anaesthesia With a Laryngeal Mask
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- the incidence of POST scores > 3
研究概览
简要总结
Postoperative sore throat (POST) is an important problem after general anaesthesia. We assessed whether chewing gum preoperatively can reduce the incidence of POST after general anaesthesia administered via a streamlined liner of the pharyngeal airway (SLIPA).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anaesthesiologists (ASA) class I or II 20-65 years body mass index (BMI) scores <30 undergoing elective hysteroscopic surgery -
排除标准
- •chronic laryngitis chronic bronchitis asthma gastroesophageal reflux allergies to study drugs recent use of non-steroidal anti-inflammatory drugs (NSAIDs) a history of upper respiratory tract infection in the past one week Mallampati grade>2 a history of steroid therapy.
研究组 & 干预措施
the control group
Active Comparator
干预措施: swallow twice (Other)
the gum group
Placebo Comparator
干预措施: chewed mint gum (Drug)
结局指标
主要结局
the incidence of POST scores > 3
时间窗: within 24 hours after surgery
POST was evaluated by the Numerical Rating Scale (NRS), which ranges from 0 to 10 points, with 0 indicating completely painless, 1\~ 3 indicating mild discomfort, 4 \~ 6 indicating moderate pain, and 7\~ 10 indicating severe pain.
次要结局
- the POST scores(2 hours, 6 hours and 24 hours after surgery.)
研究者
Tingting Wang
Director, Principal Investigator, Clinical Professor
Fudan University
研究点 (1)
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