CTRI/2024/07/071136尚未招募4 期
LMA protector vs LMA Blockbuster in Laparoscopic surgeries A prospective randomized comparative study.
Medical college baroda1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年8月22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
- 70
- 试验地点
- 1
- 主要终点
- Oropharyngeal seal pressure
研究概览
简要总结
There are many studies that proves safety and high efficacy of LMA protector in laparoscopic surgery and none for LMA Blockbuster. We aim to compare the efficacy of LMA Protector vs LMA Blockbuster in laparoscopic surgeries. Both airway devices are newer airway devices with suggested adequate oropharyngeal seal capacity, preformed curved structure for ease of insertion, inflatable airway cuff, wider airway tube for endotracheal intubation, if needed; large bore gastric tube passage for deflation of stomach; Yet there is no literature comparing these two devices in laparoscopic surgeries.
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
- All
入选标准
- •1 Patients in age group 18 to 60 years.
- •2 Either gender.
- •3 Weight 30 to 70 kg.
- •4 ASA physical status 1 and
- •5 Mallampati class 1 and
- •6 Surgeries requiring less than 4 hours.
- •7 Patients admitted in SSGH and posted for Laparoscopic Elective surgeries requiring general anesthesia.
排除标准
- •1 Patient with predicted difficult airway (mouth opening of less than 2.5cm, cervical spine problems).
- •2 Patients with recent upper respiratory tract infection.
- •3 Patients with any oropharyngeal pathology.
- •4 Patient with any known pulmonary disease (like Asthma, COPD) 5 Obese patients with BMI more than 30 kg/m
- •6 Patient with any conditions that increase the risk of gastro esophageal regurgitation.
- •History of allergy to silicon, polyvinyl chloride or to any drugs used in protocol.
- •7 Patients not willing for participation.
结局指标
主要结局
Oropharyngeal seal pressure
时间窗: At Baseline
次要结局
- Effect on Hemodynamic Parameters
- Time taken for insertion(At Baseline)
- Number of insertion attempts of SAD & gastric tube(At Baseline)
- Ease of insertion(At Baseline)
- fibreoptic view(At Baseline)
- Complications like Oro pharyngeal Trauma, Sore throat,(staining of device and Dysphonia.)
研究者
Dr Het Bhatt
Government medical college and hospital, Baroda
研究点 (1)
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