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
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
Dr. L.Geetha Ramalakshmi
SRM Medical college hospital and research centre
