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临床试验/CTRI/2024/05/066776
CTRI/2024/05/066776招募中不适用

Comparison of lignocaine gel and normal saline as lubricants on the ease of removal of a stylet from the endotracheal tube during intubation.

VMMC and Safdarjung Hospital New Delhi1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年5月14日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Force in Newton (using a spring balance) required to remove stylet from endotracheal tube in patients undergoing intubation for surgery under general anaesthesia

研究概览

简要总结

This is a Prospective Comparative Study aiming to compare the effect of lignocaine gel and normal saline as lubricants on the ease of removal of stylet from the endotracheal tube during intubation in a total of 80 patients. The primary outcome measured will be the force in Newton (using a digital force gauge) required to remove the stylet from the endotracheal tube during intubation. Secondary outcome measured will be the time taken to remove the stylet from the endotracheal tube, hemodynamic parameters following intubation and incidence of post operative sore throat using POST scoring at 6h, 12h and 24h post op and its association with the extraction force applied.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing elective surgery under general anaesthesia requiring endotracheal intubation belonging to American Society of Anaesthesiology classification I or II, Modified Mallampati grade I or II, Body mass index less than 30kg/m2.

排除标准

  • Anticipated difficult airway, Patients with high risk of aspiration.

结局指标

主要结局

Force in Newton (using a spring balance) required to remove stylet from endotracheal tube in patients undergoing intubation for surgery under general anaesthesia

时间窗: At the time of intubation

次要结局

  • To compare- time taken to remove the stylet from endotracheal tube, hemodynamic parameters following intubation, incidence of post operative sore throat using POST scoring system and its association with extraction force applied(hemodynamic parameters at insertion, after removal of stylet and after 5 mins of removal)

研究者

发起方
VMMC and Safdarjung Hospital New Delhi
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Aparna Pradeep

Vardhman Mahavir Medical College and Safdarjung Hospital

研究点 (1)

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