Blockbuster LMA Versus Baska Mask in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Oropharyngeal leak pressure
研究概览
简要总结
This study aimed to compare the performance and safety profiles of two supraglottic airway devices (SADs), the Blockbuster laryngeal mask airway (LMA) and the Baska Mask (BM), in patients underwent laparoscopic cholecystectomy (LC).
详细描述
Laparoscopic surgery has become increasingly prevalent across numerous surgical disciplines due to the well-established benefits it offers over traditional open procedures. Laparoscopic cholecystectomy (LC), the surgical removal of the gallbladder, stands out as one of the most frequently performed laparoscopic operations worldwide.
Supraglottic airway devices (SADs) play a crucial role in airway management algorithms, serving as viable alternatives in both anticipated and unanticipated difficult airway situations.
The laryngeal mask airway (LMA) can be utilized to establish a routine airway during general anesthesia or, less frequently, as a conduit for tracheal intubation. Newer, improved LMA designs incorporate cuffs that provide higher sealing pressures than classic LMAs, while also allowing for the venting of gastric contents through a dedicated drain tube.
The Baska Mask (BM), a second-generation SAD, features a non-inflatable cuff that is continuous with the airway channel, thereby inflating with positive pressure ventilation to improve cuff seal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-60 years
- •Both sexes.
- •American Society of Anesthesiologists (ASA) physical status I-II.
- •Scheduled for elective LC under general anesthesia.
排除标准
- •Anticipated difficult airway.
- •Renal dysfunction.
- •Hiatus hernia.
- •Pregnancy.
- •Patients taking rate-controlling medications, steroids, opioids, or regular antacids.
结局指标
主要结局
Oropharyngeal leak pressure
时间窗: 30 min after insertion
Oropharyngeal leak pressure was measured Just after insertion and 30 min after insertion.
次要结局
- Device insertion time(5 min after insertion)
- Complications(24 hours postoperatively)
- The incidence of successful gastric tube placement(10 min after insertion)
研究者
Rabab Mohamed Mohamed Mohamed
Assistant Professor of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt
Tanta University