Comparison of I-gel and Ambu AuraGain Without Neuromuscular Blocker in Laparoscopic Gynecological Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Change in airway seal pressure
研究概览
简要总结
To compare the effects of i-gel and Ambu AuraGain on ventilation parameters and surgical view during Trendelenburg position laparoscopic gynecological surgery in cases administered positive pressure ventilation without the use of neuromuscular agents.
详细描述
Prospective, multicenter, randomized and double-blind study, aged from 18 to 65 years undergoing elective laparoscopic gynecological surgery.
The patients are randomly assigned to 2 groups:
Group i-gel Group Ambu AuraGain
Procedure:
The investigation protocol contains the following sections:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •ASA classification I-II
- •Between 18-65 years
- •Undergoing elective laparoscopic gynecological surgery
排除标准
- •Those with any neck or upper respiratory tract pathology
- •Those at risk of gastric content regurgitation/aspiration (previous upper GIS surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcers, full stomach, pregnancy)
- •Those with low pulmonary compliance or high airway resistance (chronic pulmonary diseases)
- •Obese patients (BMI >35)
- •Those with throat pain, dysphagia and dysphonia
- •Those with possible or previous difficult airway
- •Those with operations planned for longer than 4 hours
- •Conversion to laparotomy
- •Neuromuscular blocking agent used
结局指标
主要结局
Change in airway seal pressure
时间窗: intraoperative
The maximum oropharyngeal leak pressure attained for each device.
Insertion time
时间窗: intraoperative
The time taken to successfully place the device in seconds
次要结局
- Number of attempts at insertion(intraoperative)
研究者
Sule Ozbilgin
Director
Dokuz Eylul University