AuraGainTM and I-Gel® Laryngeal Masks in General Anesthesia for Laparoscopic Cholecystectomy - Performance Characteristics and Effects on Hemodynamics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 主要终点
- Airway related complications
研究概览
简要总结
The standard procedure used for airway control in general anesthesia for LC (laparoscopic cholecystectomy) is endotracheal intubation (EI). AuraGain and I-Gel are supraglottic airway devices (SADs) used for airway control for certain types of surgeries. The aim of this study was to evaluate and compare the performances of new types of SADs with EI regarding their insertion times, durations, perioperative complications and effects on hemodynamic parameters and peak airway pressures (Paw) in LC as well.
详细描述
The standard procedure used for airway control in general anesthesia for LC (laparoscopic cholecystectomy) is endotracheal intubation (EI). AuraGain and I-Gel are supraglottic airway devices (SADs) used for airway control for certain types of surgeries.Previous studies have investigated and/or compared the performance of ProSeal™ LMA (Intavent Orthofix, Maidenhead, UK) during LC. But the performances of I-Gel and AuraGain have not been studied well yet. The main aim of this study was to evaluate and compare the performances of new types of SADs (i.e. AuraGain and I-Gel) with endotracheal intubation regarding their insertion times, ease of insertion and perioperative complications. The secondary aim was to observe their effects on hemodynamic parameters and peak airway pressures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(ASA) 1-2 physical status scheduled for elective LC
排除标准
- •under the age of 18, history of hiatus hernia, gastroesophageal reflux, body mass index (BMI) > 30 kg m-2, ASA physical status 3 or over and patients who met the difficult intubation criteria
结局指标
主要结局
Airway related complications
时间窗: Perioperative
Airway related complications like bronchospasm,gastric regurgitation,smooth tissue damages were assessed
Insertion time
时间窗: Perioperative
It was assessed that how many secs it takes to insert the device
Attempts to insertion
时间窗: Perioperative
It was assessed that how many attempts needed to insert the device
次要结局
- Heart Rate bpm(Perioperative)
- Systolic blood pressure mmHg(Perioperative)
- Peak airway pressure(Perioperative)
- Diastolic blood pressure mmHg(Perioperative)
研究者
Dr. Ülkü Sabuncu
Principal Investigator, Ulku Sabuncu, MD, Anesthesiology and Reanimation
Adiyaman University Research Hospital