跳至主要内容
临床试验/CTRI/2022/09/045908
CTRI/2022/09/045908尚未招募4 期

Comparison between baska mask and I- gel Insertion in minor surgery under general anaesthesia in Patient age 18-50 years:-a randomized interventional study at SMS medical college, during 2021-2023

Department of Anesthesiology SMS Medical College and hospitals1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To determine the difference in mean orophargeal leak pressure in both groups after insertion and 5 min later.

研究概览

简要总结

We want to compare between baska mask and I-gel insertion in minor surgery under general Anesthesia in patient aged 18-50 years .to determine in mean orophargeal Leak pressure in both groups after insertion and 5 min later .to determine in insertion characteristic in both the groups.to determine the difference in removal characteristics and percentages of postop complications.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Adult patient of 18-50 years of age .
  • 2.Weight of 30-60 kgs 3.ASA grade I and II 4.Undergoing minor surgical procedure under general anaesthesia.
  • 5.Sex both male and female.

排除标准

  • 1.Known/predicted difficult airway 2.mouth opening <2.5cm 3.with increase risk of aspiration of gastric content .
  • 4.surgery time more than 1 hour.
  • 5.obesity ( BMI>30kg/m2) 6.negative patient consent.

结局指标

主要结局

To determine the difference in mean orophargeal leak pressure in both groups after insertion and 5 min later.

时间窗: just after insertion, after 5 min

次要结局

  • insertion time(time between picking up airway device and 1st capnographic reading)
  • attempts of insertion(preoperatively and intraoperatively)
  • postoperatively removal charactestics-blood staining on device,trauma to lip,tongue or teeth,sump clearance,gastric fluid in airway cavity(postoperatively)
  • haemodynamic HR,SBP,MAP,SPO2,ETCO2(baseline, before induction,just after induction, after 1 min, after 5 min,then every 5 min till 40 min, at 50 min ,at 60 min)
  • grading of ease of insertion(pre and intraoperatively)
  • manipulation frequency(intraoperatively)

研究者

发起方
Department of Anesthesiology SMS Medical College and hospitals
申办方类型
Government medical college

研究点 (1)

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