CTRI/2024/06/068772尚未招募2/3 期
A prospective randomised study Comparing clinical performance of AMBU AURAGAIN and LMA BLOCKBUSTER in adult patients undergoing general anaesthesia for elective surgeries.
Department of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年6月26日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Oropharyngeal seal pressure(OSP)
研究概览
简要总结
It is a prospective randomised study comparing clinical performance of AMBU AURAGAIN and LMA BLOCKBUSTER in adult patients undergoing general anaesthesia for elective surgeries of less than 2 hrs duration.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade I and grade II Patients.
- •Age- 18 to 65 years of either sex.
- •Patients undergoing surgery under general anaesthesia.
- •Anticipated normal airway in preanaesthetic evaluation.
- •Posted for surgery requiring supine position only.
排除标准
- •Patients with anticipated difficult airway
- •Anticipated high risk of aspiration (hiatus hernia, full stomach, pregnancy, gastro-oesophageal reflux).
- •Preoperative respiratory tract infection.
- •Patients with history of allergy or sensitivity to any medication, latex or egg.
结局指标
主要结局
Oropharyngeal seal pressure(OSP)
时间窗: Once after insertion of supraglottic airway device
次要结局
- Number of attempts taken(For successful insertion of device)
- Time taken for effective insertion(Upto securing the airway)
- Ease of insertion of device and gastric tube placement(During insertion of device)
- Hemodynamic parameters (BP, HR, SPO2)(Baseline, every 5 minutes for initial 15 minutes and then every 15 minutes till end of the surgery.)
- Post-op complications (Displacement, blood staining, Sore throat, hoarseness, injury)(After extubation)
研究者
Dr Sweta
LLRM Medical College
研究点 (1)
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