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临床试验/CTRI/2025/03/081938
CTRI/2025/03/081938招募中不适用

To study the effect of cuff insufflation with lidocaine, saline or air on post operative sore throat during laparoscopic surgeries in steep Trendelenburg position

Dr Sarthak Misra1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年3月31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
90
试验地点
1
主要终点
To compare the tracheal tube cuff pressure after inflation with air, normal saline, or lignocaine at various time points during laparoscopic surgeries in the steep Trendelenburg position.

研究概览

简要总结

Nowadays, ultrasound is simple to obtain, it is unknown whether tracheal tube cuff pressure correlates with tracheal transverse diameter (TD) and tracheal tube cuff transverse diameter (CD). So this prospective randomized controlled trial is hypothesized to assess endotracheal tube cuff pressure after pneumoperitoneum, the severity of tracheal mucosal damage and postoperative airway complications when the tracheal tube cuff was inflated with room-temperature air, 2% lidocaine or NSand to investigate if TD and CD measured by ultrasound can be used to predict tracheal tube cuff pressure.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Patient of ASA 1, ASA 2 and ASA 3 physical status Patients between 18-65 years of age of either sex Patient with Mallampati Class I-II Patients posted for major laparoscopic surgeries under General Anaesthesia in steep trendelberg position •Patient willing to Participate.

排除标准

  • Patient with Pregnancy, morbid obesity, and history of sore throat, asthma, COPD, psychiatric disorders and smokers.
  • Patient who required reintubation after extubation within 48hours.
  • Patient who had delayed emergence or transferred to ICU intubated after operation under General Anaesthesia.

结局指标

主要结局

To compare the tracheal tube cuff pressure after inflation with air, normal saline, or lignocaine at various time points during laparoscopic surgeries in the steep Trendelenburg position.

时间窗: 5 minutes, 30 minutes, 1 hour, 12 hours, 24 hours

次要结局

  • To assess the severity of Postoperative airway complications like sore throat, & hoarseness at 2 hr, 12 hr & 24hr time intervals(2 hours, 12 hours, 24 hours)

研究者

发起方
Dr Sarthak Misra
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sarthak Misra

Indira Gandhi institute of medical sciences

研究点 (1)

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