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临床试验/CTRI/2022/04/041674
CTRI/2022/04/041674尚未招募2/3 期

“A Comparative study between i-gel and Proseal LMA in adult patients undergoing elective laparoscopic cholecystectomy under general anaesthesia: A randomised controlled study.â€

Rajendra Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年9月4日最近更新:
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试验速览

阶段
2/3 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
1.Knowing the oropharyngeal sealing pressure with Proseal LMA.
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Supraglottic airway devices are now used for airway control during spontaneous and controlled ventilation under general anaesthesia.

The safety of these devices with gastric access has been accessed through some studies in laparoscopic cholecystectomy over last decade. Though studies have been done for LMA, few have been performed to evaluate i-gel for Laparoscopic Cholecystectomy

This study will be done to compare i-gel and Proseal LMA for airway sealing pressure during volume control ventilation for their use in elective laparoscopic cholecystectomy

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Investigator 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

  • •Patient’s consent Weighing between 40-80 kg ASA physical status I & II Mallampatti class I & II.

排除标准

  • •Patient’s refusal ASA grade III & IV Age less than 18 years and more than 60 years.
  • •Weight less than 50 kg or more than 80 kg.
  • •Patient with upper respiratory tract infection.
  • •Mallampatti class III & IV.
  • •Patient with h/o hypertension, DM, coronary heart disease.
  • •Patient with increased risk of aspiration (GE reflux, hiatus hernia, Pregnancy).
  • •Injury, deformity or any pathology of the airway.

结局指标

主要结局

1.Knowing the oropharyngeal sealing pressure with Proseal LMA.

时间窗: 0min,10min,30min

2.Knowing the oropharyngeal sealing pressure with i-gel.

时间窗: 0min,10min,30min

次要结局

  • Ease of insertion(Time taken to achieve airway control)

研究者

申办方类型
Government medical college

研究点 (1)

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