Evaluation of Gender Specific Differences in Postoperative Sore Throat Following General Anaesthesia With Ambu® AuraGain™ Laryngeal Mask
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 814
- 试验地点
- 2
- 主要终点
- Gender specific differences in sore throat 24 hours postoperative
研究概览
简要总结
The purpose of this study is to evaluate gender specific risk factors and the influence of cuff pressure in the occurrence of postoperative sore throat and hoarseness following general anaesthesia using Ambu® AuraGain™ Laryngeal Mask.
详细描述
The history and physical examinations of all patients scheduled for surgery are screened preoperatively for exclusion criteria. Patient recruitment is conducted by one of the study physicians. After eligibility is confirmed and written informed consent is obtained, enrolled participants are randomized depending on their gender (400 men, 400 women) in a single-blinded manner (patients) 24 hours before the intervention in a 1:1 ratio to low cuff pressure (45 cmH2O) or normal cuff pressure (60 cmH2O). Patient questioning via questionnaire is conducted in postoperative anaesthetic care unit, 24h, 48h and 72h until freedom of symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Patients are allocated to the cuff pressure groups via block randomization
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •elective surgery in ophthalmology under general anaesthesia with laryngeal mask
- •Age > 18
- •informed written consent
排除标准
- •Anticipated difficult airway with indication for awake tracheal intubation
- •Indication for RSI or elevated risk for aspiration;
- •Pregnant or breastfeeding;
- •Age < 18 years;
- •Out-patient surgery (Geb. 505);
- •Limited mouth opening;
- •Pre-existing hoarseness and sore throat
- •Participant in other studies
- •Unable to provide informed written consent or under guardianship
结局指标
主要结局
Gender specific differences in sore throat 24 hours postoperative
时间窗: 24 hours after general anaesthesia (removal of laryngeal mask)
Comparing the incidence of postoperative sore throat between males and females within the first 24 hours after general anaesthesia with a second-generation Ambu® AuraGain™ Laryngeal Mask for elective, ophthalmological surgery
Differences in sore throat 24 hours postoperatively in correlation to cuff pressure
时间窗: 24 hours after general anaesthesia (removal of laryngeal mask)
Comparing the incidence of postoperative sore throat within the first 24 hours after general anaesthesia with a second-generation Ambu® AuraGain™ Laryngeal Mask for elective, ophthalmological surgery in correlation to cuff pressure (45 cmH2O and 60 cmH2O)
次要结局
- Risk factors for postoperative sore throat in correlation to gender and cuff pressure(From end of general anaesthesia (removal of laryngeal mask) until at minimum Day 3. If symptoms persist past Day 3 postoperatively, the maximum observation period is 100 days or until freedom of symptoms (whichever comes first))
研究者
Katharina Epp
Dr.med. Katharina Epp
Johannes Gutenberg University Mainz