Comparative evaluation of three different techniques (standard, reverse and rotation) of I-Gel insertion in patients undergoing surgery under General Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- To compare the first-attempt success rate of i-GEL insertion using the standard, reverse, and rotational techniques.
研究概览
简要总结
This randomised, controlled trial aims to compare the efficacy of the three techniques of iGel insertion in adult patients undergoing elective surgeries under general anaesthesia. A total of 264 ASA I–II patients will be randomly divided into three groups: standard technique (Group S), reverse technique involving a 180° rotation (Group R), and rotational technique using a 90° rotation (Group T). After standard anaesthetic induction and neuromuscular relaxation, the i-gel will be inserted using the assigned technique. Key outcome measures included first-attempt success rate, insertion time, oropharyngeal leak pressure, ease of gastric tube placement, fibreoptic grading, and the incidence of complications such as sore throat, blood staining, and dysphagia at 1 and 24 hours.
By providing a comprehensive head-to-head comparison of standard, reverse, and rotational i-gel insertion methods, this research intends to generate clinically relevant evidence that can enhance anaesthetic practice. The findings are expected to assist anaesthesiologists in selecting the most effective technique for i-gel placement, thereby improving patient safety and procedural efficiency in airway management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •ASA Physical Status I and II Mallampati Class I–II BMI 18–25 kg/m² Elective surgeries requiring general anaesthesia Surgeries in supine position.
排除标准
- •Predicted difficult airway (Mallampati III/IV, restricted mouth opening, limited neck mobility) Risk of aspiration (full stomach, GERD, pregnancy) Upper respiratory tract infection or recent sore throat Emergency surgeries.
结局指标
主要结局
To compare the first-attempt success rate of i-GEL insertion using the standard, reverse, and rotational techniques.
时间窗: At the time of insertion
次要结局
- To compare the time taken for i-GEL insertion among the three techniques.(To compare the oropharyngeal leak pressure (OLP) achieved with each technique.)
研究者
Sivagurunathan
Swani Dayanand hospital
