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临床试验/CTRI/2024/02/062179
CTRI/2024/02/062179尚未招募4 期

A Randomised Clinical study To Compare BASKA MASK Vs I-GEL in Female Patients undergoing Diagnostic Laproscopic Gynaecological surgeries under General Anaesthesia

Deparrment of anaesthesiology JLN medical college1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年2月6日最近更新:
适应症
相关药物

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

发起方
Deparrment of anaesthesiology JLN medical college
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Beena Thada

JLN medical college ajmer

研究点 (1)

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