CTRI/2022/04/042330尚未招募不适用
Comparison between Blockbuster Laryngeal Mask Airway and Proseal Laryngeal Mask Airway in paediatric patients under controlled ventilation
Department of Anaesthesiology IPGMER Kolkata1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2022年9月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- To compare the oropharyngeal leak pressure of the two SGA devices
研究概览
简要总结
The study will assess the safety and efficacy of Blockbuster LMA in airway management in comparison to Proseal LMA for elective non laparoscopic surgery in paediatric patients under General Anaesthesia with muscle relaxation and controlled ventilation
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA Class I and II Having no congenital anomaly Posted for elective non laparoscopic surgery under General Anaesthesia.
排除标准
- •Parental refusal Having congenital anomaly, airway difficulty Known cardiovaascular,hepatic, pulmonary, renal,neurological, endocrinological diseases.
结局指标
主要结局
To compare the oropharyngeal leak pressure of the two SGA devices
时间窗: Following placement of the devices in the airway and induction of GA with muscle relaxation under controlled ventilation
次要结局
- Incidence of successful placement of the respective LMA(During Induction of anaesthesia)
- Incidence of post operative sore throat(24 hour post operative period)
- Visualization of glottis through the SGA by fibreoptic scope(After Insertion of the devices)
- Insertion time for the two devices(During insertion of the devices)
- Ease of gastric tube insertion(Following placement of the devices)
研究者
研究点 (1)
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