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临床试验/CTRI/2026/01/101354
CTRI/2026/01/101354尚未招募不适用

A Comparative study between Proseal LMA Versus Endotracheal tube among Anaesthetized adult patients undergoing Elective Laparoscopic Cholecystectomy procedures: A Prospective Observational Study

Dr Kiran A V1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2026年1月22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
62
试验地点
1
主要终点
Change in hemodynamic parameters (Heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure) following airway insertion using Proseal laryngeal mask airway compared with endotracheal tube.

研究概览

简要总结

This study is designed to compare the hemodynamic stress response and ease of insertion between ProSeal laryngeal mask airway and endotracheal tube in adult patients undergoing elective surgery under general anaesthesia. Participants will be randomly allocated to receive airway management using either ProSeal laryngeal mask airway or endotracheal tube. Hemodynamic parameters such as heart rate and blood pressure will be recorded at baseline and at predefined time intervals following airway insertion. Ease of insertion will be assessed using standard clinical criteria. The outcomes will be compared between the two groups.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Informed written consent Patients with ASA 1 And ASA 2 Patients undergoing Laparoscopic Cholecystectomy under GA with either proseal LMA or endotracheal tube Mallampati 1 and 2.

排除标准

  • Patients with Anticipated Difficult airway H/O OSA Upper respiratoery tract infections Patients with incresed risk of Aspiration.

结局指标

主要结局

Change in hemodynamic parameters (Heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure) following airway insertion using Proseal laryngeal mask airway compared with endotracheal tube.

时间窗: Baseline(before airway insertion), immediately after insertion, and at 1, 3 and 5 minutes after airway insertion.

次要结局

  • To compare Proseal LMA Vs Endotracheal tube with respect to side effects(Post operatively every 3hrly upro 24hrs.)

研究者

发起方
Dr Kiran A V
申办方类型
Other [Associate professor]
责任方
Principal Investigator
主要研究者

Dr Kiran A V

Mandya institute of medical sciences

研究点 (1)

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