Evaluation of safety and efficacy of Supreme LMA and I-GEL as compared to endotracheal tube in hysterolaparoscopic surgeries under general anaesthesia: An Interventional study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To determine change in oropharyngeal leak pressure
研究概览
简要总结
This interventional study aims to evaluate and compare the safety and efficacy of two supraglottic airway devices — LMA Supreme and i-gel — with the conventional endotracheal tube (ETT) in patients undergoing hysterolaparoscopic surgeries under general anaesthesia. The study will assess parameters including ease of insertion, hemodynamic stability, oxygenation and ventilation efficacy, airway complications, and postoperative outcomes. A total of 66 patients will be randomized into three groups to receive either the LMA Supreme, i-gel, or ETT during surgery. All patients will be monitored intraoperatively and postoperatively for airway-related complications, insertion time, oropharyngeal leak pressure, and other relevant clinical indicators.
The findings of this study will help determine whether these less invasive airway devices can serve as safe and effective alternatives to endotracheal intubation in laparoscopic gynecological procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •18-60 years female with ASA Grade I,II and III undergoing elective hysterolaparoscopic surgical procedure under general anaesthesia with expected duration of surgery less than 2 hours.
排除标准
- •Patient refusal BMI more than 35 kg/m² Mallampati class 3 & 4 Inter incisor distance less than 20mm Thyromental distance less than 65mm Oropharyngeal pathology Restricted neck mobility or any cervical spine pathology History of gastro esophageal reflux disease, hiatus hernia Obstructive sleep apnea.
结局指标
主要结局
To determine change in oropharyngeal leak pressure
时间窗: Oropharyngeal leak pressure will be determined after securing the airway | Inspired tidal volume, expired tidal volume and peak airway pressure will be recorded at 1 minute, 3 minutes, 5 minutes, 10 minutes and there after every 20 minutes and 30 minutes.
To evaluate ventilator parameters post insertion
时间窗: Oropharyngeal leak pressure will be determined after securing the airway | Inspired tidal volume, expired tidal volume and peak airway pressure will be recorded at 1 minute, 3 minutes, 5 minutes, 10 minutes and there after every 20 minutes and 30 minutes.
次要结局
- To record hemodynamic responses.(To assess ease of insertion and time to establish effective ventilation)
研究者
Dr Ogirala Keerthana
Pt JNM medical college