Comparison of clinical efficacy of laryngeal mask airway Protector with laryngeal mask airway Proseal for ventilation in patient undergoing laparoscopic cholecystectomy under general anaesthesia.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Oropharyngeal leak pressure will be noted within 5 minutes after device insertion.
研究概览
简要总结
The study is a prospective ranadmoized interventional comparative study to compare clinical efficacy of Laryngeal Mask Airway Protector with Laryngeal mask airway Proseal for ventilation, in patients undergoing laparoscopic cholecystectomy under general anaesthesia, with hypothesis that the clinical efficacy of laryngeal mask airway Protector is equivalent to that of laryngeal mask airway ProSeal for ventilation in terms of oropharyngeal leak pressure in patients undergoing laparoscopic cholecystectomy under general anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •144 patients, in age group of 18 to 60 years, American society of Anaesthesiologists (ASA) physical status I and II undergoing laparoscopic cholecystectomy under general anaesthesia.
排除标准
- •Patients with anticipated difficult airway including: Thyromental distance<6.5 cm, Upper lip bite test class<1, Mallampati class III and IV, Restricted head and neck mobility, Mouth opening <3.5 cm, BMI>30kg/m2, Cervical spine pathology, High risk of aspiration.
结局指标
主要结局
Oropharyngeal leak pressure will be noted within 5 minutes after device insertion.
时间窗: Oropharyngeal leak pressure will be noted within 5 minutes after device insertion. | Other reading of oropharyngeal leak pressure will be taken after inflation & after deflation of carboperitoneum.
Other reading of oropharyngeal leak pressure will be taken after inflation & after deflation of carboperitoneum.
时间窗: Oropharyngeal leak pressure will be noted within 5 minutes after device insertion. | Other reading of oropharyngeal leak pressure will be taken after inflation & after deflation of carboperitoneum.
次要结局
- insertion characteristics(1.NUMBER OF ATTEMPTS TAKEN FOR SUCCESSFUL INSERTION OF DEVICE)