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临床试验/CTRI/2024/02/063035
CTRI/2024/02/063035尚未招募4 期

A randomised controlled study to compare the first attempt success rate at insertion of LMA protector TM and i-gel TM in elective surgical procedures

SRM Medical collage Hospital and Research centre1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年3月4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
110
试验地点
1
主要终点
First attempt success rate

研究概览

简要总结

This study will be performed in patients scheduled to undergo minor surgical procedures under general anaesthesia. A written informed consent will be obtained from the participants. The participants will be allocated into two groups by computer-generated random numbers. Group A is LMA Protector and Group B is i-gel. Anaesthesia premedication and induction will be standardized among the groups. After adequate attainment of intubating conditions, either LMA protector or i-gel will be introduced in their respective groups by postgraduate students who have done a minimum of 25 classic LMA successful insertions. Proper placement of the airway device is confirmed by five-point auscultation and ETCO2 tracings on the capnograph. The time taken and the number of attempts to secure the airway will be noted. At the end of the surgery, SAD  will be removed on regaining of adequate consciousness and intact airway reflexes. The surface of the device will be examined for any blood staining and will be recorded. Any episodes of laryngospasm will be documented and managed as per standard protocols. Any complaints of sore throat will be documented.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • ASA 1 and ASA 2 patients All elective procedures MPC Grade 1 and 2 patients.

排除标准

  • Patients with Risk of aspiration Patients with history of GERD.

结局指标

主要结局

First attempt success rate

时间窗: 0 minute to 1 minute

次要结局

  • time taken for insertion(number of attempts for successful airway attainment)

研究者

发起方
SRM Medical collage Hospital and Research centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr. L.Geetha Ramalakshmi

SRM Medical college hospital and research centre

研究点 (1)

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