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临床试验/CTRI/2020/06/025534
CTRI/2020/06/025534尚未招募不适用

I-GEL vs SUPREME LMA: A COMPARISON BETWEEN TWOSUPRAGLOTTIC AIRWAY DEVICES IN AIRWAYMANAGEMENT OF MPS III/IV PATIENTS COMING FORLAPAROSCOPIC CHOLECYSTECTOMY

Indira Gandhi medical college1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年2月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
1) 2) To compare and evaluate ease and success of airway management with these two devices with respect to total time taken for insertion, number of attempts and failure rate. To compare the airway seal pressures of two devices.

研究概览

简要总结

This study is about comparison between two second generaton supraglottic airway devices i.e I-gel and LMA supreme in regarding  ease and success of airway management and airway seal pressures as primary objectives. Hemodynamc responses after insertion,ease of gastric tube insertion,leak after pneumoperitoneum and incidence of oropharyngeal trauma,sorethroat,hoarseness of voice are observed between two devices as secondary objectives

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients giving consent for participating in the study.
  • Patients with the age of 18- 50 years who are ASA I and weighing between 50-70 kg coming for elective laparoscopic cholecystectomy having MPS 3/4.

排除标准

  • Patients having abnormal airway anatomy, tonsillar hypertrophy, hematoma and abscess.
  • History of any condition which increase the risk of regurgitation of gastric contents-Full stomach (less then 8 hours fasting), uncertainty about intake of food or drink Trauma Intra-abdominal pathology like intestinal obstruction, peritonitis, gastric paresis.
  • Diabetes (gastro paresis diabeticorum) Uremia (uremic enteropathy) Esophageal disease like symptomatic reflux motility disorder Pregnancy.

结局指标

主要结局

1) 2) To compare and evaluate ease and success of airway management with these two devices with respect to total time taken for insertion, number of attempts and failure rate. To compare the airway seal pressures of two devices.

时间窗: Insertion time-After induction of patient | Airway seal pressure- 2 minutes after insertion of device

次要结局

  • 1) 2) 3) To compare hemodynamic response to insertion of i-gel and LMA supreme. To check whether pneumoperitoneum causes leak with these supraglottic airways To compare the incidence of oropharyngeal trauma and of sore throat and hoarseness postoperatively among patients of both the groups.(Hemodynamic response- Heart rate,MAP is recorded during first 7 minutes every minute after insertion)

研究者

申办方类型
Government medical college

研究点 (1)

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