Comparative Evaluation Of Oropharyngeal Seal Pressure Of I-gel With I-gel Plus In Adult Patients Undergoing Laparoscopic Cholecystectomy Under General Anaesthesia: A Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To compare the mean oropharyngeal seal pressures between i-gel and i-gel Plus five minutes after device insertion under general anaesthesia
研究概览
简要总结
Title of my thesis is, COMPARATIVE EVALUATION OF OROPHARYNGEAL SEAL PRESSURE OF I-GEL WITH I-GEL PLUS IN ADULT PATIENTSUNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY UNDER GENERAL ANAESTHESIA. We are going to take sample size of 72.36 in each group and we are going to compare sealing pressures of i-gel and i-gel Plus five minutes after device insertion and five minutes after creating pneumoperitoneum, Number of attempts taken for device insertion, insertion ease, first attempt success of gastric tube insertion and brimacombe scoring for successful device placement will also be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA Grade 1,2,3.
排除标准
- •1.Body Mass Index (BMI)Greater Than or equal to 35kg/m2 2.Pregnancy 3.Increased risk of aspiration (such as Gastroesophageal reflux disease, diabetes mellitus etc.)
- •Anticipated difficult airway.
结局指标
主要结局
To compare the mean oropharyngeal seal pressures between i-gel and i-gel Plus five minutes after device insertion under general anaesthesia
时间窗: It will be done after induction of general anesthesia- five minutes after device insertion.
次要结局
- Mean oropharyngeal seal pressure five minutes after creating pneumoperitoneum(It will be done intraoperatively five minutes after creating pneumoperitoneum)
- Time taken for successful device placement.(It will be measured in seconds while inserting the device)
- Number of attempts for successful device placement(It will be done after induction of general anaesthesia)
- Insertion ease of device(It will be subjective assessment done after induction of general anaesthesia)
- First attempt success of gastric tube insertion(It will be done after device insertion)
- Brimacombe scoring for assessment of device placement(It will be done after device insertion)
- Complications if any with either device(It will be done during removal of the device)
研究者
Sandhiya B
Maulana Azad Medical College And Associated Lok Nayak Hospital