A Randomised Clinical study To Compare BASKA MASK Vs I-GEL in Female Patients undergoing Diagnostic Laproscopic Gynaecological surgeries under General Anaesthesia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the mean Oropharyngeal Leak Pressure(OLP) just after
研究概览
简要总结
Upon arrival in operation theatre, the written informed consent, PAC, and nil per oral status will be confirmed. Study population (100) will be randomly divided into two groups by opaque sealed envelope technique. Group B (n=50) will receive Baska Mask and Group I(n=50) will receive I-Gel.
In case of securing the airway with supraglottic airway device while using Baska Mask, the patient will be placed in sniffing position. The Baska Mask will be lubricated and introduced into the mouth toward the hard palate and advanced downward until resistance felt. while using I-GEL . The tip of the I-Gel will be introduced into the mouth of the patient against the hard palate, avoiding the tongue, and glided downward and backward until a definitive resistance will be felt. patient will be monitored for mean oropharyngeal leak pressure as primary objective and ease of insertion, peak airway pressure and post operative complication as secondary objective. data will be collected and analysed using standard tests , p value of less than 0.05 will be considered significant
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •Adult female of 20-40yrs age group
- •Weight of 30-60kgs
- •ASA grade I and II
- •Undergoing Diagnostic laproscopic gynaecological surgeries under general anaesthesia.
- •Surgeries lasting upto 60 minutes.
排除标准
- •1.known airway difficulty 2.mouth opening less than 2.5 cm 3.obesity 4.negative patient consent.
结局指标
主要结局
To compare the mean Oropharyngeal Leak Pressure(OLP) just after
时间窗: just after successful insertion of LMA, at 10 mnts after creating pneumoperitoneum
successful insertion and 10 minutes after creating pneumoperitoneum.
时间窗: just after successful insertion of LMA, at 10 mnts after creating pneumoperitoneum
次要结局
- 1.to compare ease of insertion(2.to compare peak airway pressure)
研究者
Dr Beena Thada
JLN medical college ajmer
