跳至主要内容
临床试验/CTRI/2023/03/050900
CTRI/2023/03/050900已完成不适用

"Evaluation of post operative sore throat (POST) using standardversus smaller sized cuffed endotracheal tubes in patients undergoing laparoscopic surgeries."

Mahatma gandhi Medical College1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年1月5日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
To compare the incidence of post operative sore throat

研究概览

简要总结

Post operative sore throat is quite common occurence following general anaesthesia after tracheal intubation and impairs post operative recovery.it is a minor complication but ensures about patient comforts and further complications.Factors such as tracheal tube size and cuff design have been showed to be an important causative factors.Routine tracheal intubation for elective surgical procedure can result in pathological changes,trauma and nerve damage which may also accounts for post operative symptoms.Sore throat following the use of laryngeal mask appears to be related to insertion of technique.High intracuff pressure is associated with nerve palsies due to neuropraxia and nerve compression.Careful insertion of both tracheal tube and laryngeal mask paramounts to prevention of airway trauma and post operative sore throat. The goal is to relieve post operative sore throat and hoarseness of voice with minimal complications.Smaller diameter tracheal tube may decreases the rate of post operative sore throat.The concern may be increase the resistance to airflow and mean airway pressure.These effects can be attenuated by lower tidal volume with positive end expiratory pressure.We hypothesized that smaller tracheal tube would reduce the rate of postoperative sore throat without significantly increase in pressure during mechanical ventilation with lower tidal volume.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator 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

  • Patient fullfillig criteria of american society of anaesthesiology (ASA) of class I/II Patient aged 18-65 years of both sexes Patient posted for laproscopic surgeries under general annaesthesia Patient giving consent for the study.

排除标准

  • Sore throat AND hoarseness Anticipated difficult airway Upper respiratory infection more than 1 month Moderate/severe obstructive pulmonary disease Previous ARDS or lung resection BMI>35kg Surgeries in trendlenberg position.

结局指标

主要结局

To compare the incidence of post operative sore throat

时间窗: until 24 hours after extubation

次要结局

  • To compare intra operative ventilatory parameter like peak inspiratory pressure,plateau pressure,cuff pressure and end tidal co2.(150 minutes)
  • To compare the severity of post operative sore throat, if it occurs(until 24 hours after extubation)

研究者

发起方
Mahatma gandhi Medical College
申办方类型
Private medical college

研究点 (1)

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