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临床试验/CTRI/2025/10/096068
CTRI/2025/10/096068尚未招募不适用

Comparison of preoperative nebulisation with Lignocaine versus Budesonide for prevention of Post Operative Sore Throat after Supraglottic Airway insertion in adult patients undergoing general anaesthesia.

ABVIMS AND DRRML HOSPITAL1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年10月26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
86
试验地点
1
主要终点
Incidence and severity of Post Operative Sore Throat using POST scale

研究概览

简要总结

This is a randomised comparative study to compare the effect of preoperative nebulisation with Lignocaine versus Budesonide for prevention of Post Operative Sore Throat after supraglottic airway inserion in adult patients undergoing General Anaesthesia.

Total sample size - 86 (43 patients in neach group)

Primary Objective is to compare preoperative nebulisation with Lignocaine versus Budesonide for prevention of post operative sore throat after supraglottic airway insertion in adult patients undergoing general anaesthesia.

Secondary Objective is

  1. To compare preoperative nebulisation with Lignocaine versus Budesonide for prevention of post operative dysphagia after supraglottic airway insertion in adult patients undergoing general anaesthesia.

  2. To compare preoperative nebulisation with Lignocaine versus Budesonide for prevention of post operative cough after supraglottic airway insertion in adult patients undergoing general anaesthesia.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

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

入选标准

  • Patients with BMI less than 30kg/m²; ASA I and II patients; Patients posted for elective surgery of 2-3 hours duration requiring supraglottic airway insertion under general anaesthesia.

排除标准

  • Patient with allergy to the study drugs; Patients with upper respiratory tract infections within the last two weeks; Patients with anticipated difficult airway; Patients with history of asthma, COPD or any other respiratory illness; Patients requiring more than 2 attempts at SGA insertion or alternative SGA placement or endotracheal intubation; Patients with history of recent steroid use; Patients undergoing surgery of more than 3 hours duration.

结局指标

主要结局

Incidence and severity of Post Operative Sore Throat using POST scale

时间窗: 1hour, 2hours, 4hours, 6hours and 24 hours post-operatively

次要结局

  • Incidence & severity of dysphagia using NRS(6hours & 24 hours post operatively)
  • Incidence & severity of Cough using Cough Symptom Score(1hour, 2hours, 4hours, 6 hours & 24hours post operatively)

研究者

发起方
ABVIMS AND DRRML HOSPITAL
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Mounica L

ABVIMS and Dr.RML Hospital

研究点 (1)

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