临床试验/CTRI/2025/09/094321

CTRI/2025/09/094321尚未招募不适用

A Randomized Trial to Study the Efficacy and Safety of I-gel Plus ® and LMA BlockBuster ™ in Elective Laparoscopic Cholecystectomy

Dr Neeraj N N1 个研究点分布在 1 个国家目标入组 80 人开始时间: 2025年9月18日最近更新: 2025年9月7日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 80
试验地点: 1
主要终点: To compare oropharyngeal leak pressure (OLP) between I-gel Plus ®and LMA BlockBuster ™

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This randomized controlled trial at AIIMS Gorakhpur compares the efficacy and safety of i-gel Plus® and LMA BlockBuster™ in adult patients undergoing elective laparoscopic cholecystectomy. Eighty patients were randomly assigned to two groups (n=40 each). The primary outcome was oropharyngeal leak pressure (OLP). Secondary outcomes included insertion time, number of attempts, hemodynamic changes, and postoperative complications. The study aims to guide the selection of an optimal supraglottic airway device for laparoscopic surgeries requiring effective airway sealing.

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 1 & 2 patients posted for elective laparoscopic Cholecystectomy.

排除标准

•Pt with anticipated difficult airway or BMI more than
•GERD or full stomach.
•Suspected upper airway pathology and pregnancy.

结局指标

主要结局

To compare oropharyngeal leak pressure (OLP) between I-gel Plus ®and LMA BlockBuster ™

时间窗: intraoperative

次要结局

To assess ease of insertion via comparing the insertion time and number of attempts taken
To compare leak fraction
To evaluate hemodynamic changes during insertion.
To record and compare postoperative complications such as sore throat, hoarseness, dysphagia, mucosal trauma, and nausea/vomiting.

研究者

发起方

Dr Neeraj N N

申办方类型

Other [self]

责任方

Principal Investigator

主要研究者

Dr Neeraj N N

AIIMS Gorakhpur

研究点 (1)

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