Comparison of LMA Protector and I-Gel Use in Low-Flow Anesthesia for Laparoscopic Cholecystectomy: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Dynamic Lung Compliance (Cdyn)
研究概览
简要总结
This prospective randomized study aims to compare two second-generation supraglottic airway devices (SGAs), the I-Gel and the laryngeal mask airway (LMA) Protector, in patients undergoing laparoscopic cholecystectomy under low-flow desflurane anesthesia. The study evaluates the devices in terms of respiratory mechanics (dynamic compliance, peak inspiratory pressure, plateau pressure, and airway resistance), non-invasive perfusion parameters (oxygen reserve index, perfusion index, and pleth variability index), hemodynamic stability, ease of insertion, oropharyngeal leak pressure, and postoperative complication rates.
详细描述
Sixty-two patients (ASA I-II, aged 18-65 years) scheduled for elective laparoscopic cholecystectomy were randomized into two groups: Group I (I-Gel) and Group P (LMA Protector). General anesthesia induction was standardized, and maintenance was provided with desflurane at a fresh gas flow of 1 L/min to achieve low-flow anesthesia. Peak inspiratory pressure (PIP), plateau pressure (Pplato), dynamic compliance (Cdyn), and airway resistance were recorded at six distinct intraoperative time points: 5 minutes after SGA insertion (T1), 1 minute after pneumoperitoneum insufflation (T2), 1 minute after the 30-degree reverse Trendelenburg position (T3), 10 minutes after insufflation (T4), 1 minute after desufflation (T5), and immediately before SGA removal (T6). Oropharyngeal leak pressure (OLP) was measured after insertion and before removal. Postoperative complications such as sore throat, cough, hoarseness, dysphagia, and nausea-vomiting were monitored postoperatively.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 years
- •American Society of Anesthesiologists (ASA) physical status I or II
- •Scheduled for elective laparoscopic cholecystectomy
排除标准
- •Known or predicted difficult airway or history of difficult intubation
- •Body Mass Index (BMI) greater than 35 kg/m²
- •High risk of gastroesophageal reflux or aspiration
- •Severe cardiac, respiratory, renal, or hepatic disease
- •Pregnancy
- •Patient refusal to participate
结局指标
主要结局
Dynamic Lung Compliance (Cdyn)
时间窗: Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
Dynamic compliance of the respiratory system, calculated automatically by the ventilator as tidal volume divided by (peak inspiratory pressure minus positive end-expiratory pressure).
次要结局
- Peak Inspiratory Pressure (PIP)(Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.)
- Plateau Pressure (Pplateau)(Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.)
- Airway Resistance(Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.)
研究者
Ahmet Emre Akın
Medical Doctor, Principal Investigator
Fatih Sultan Mehmet Training and Research Hospital