Comparative Evaluation of Budesonide and Fluticasone nebulisation in preventing Post operative Sore Throat
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- To compare incidence, severity and duration of sore throat in all 3 groups
研究概览
简要总结
A prospective, randomized, double blind clinical study will be conducted on total of 159 patients divided into 3 groups of 53 each.Patients aged 18 to 70 years, ASA grade 1-3 and patient undergoing elective surgery under general anaesthesia, lsting greater than 2hours and requiring endotracheal tube and ryle’s tube insertion , will be included in the study. Group B patients will be nebulised with budesonide 500 mcg diluted to 5ml, Group F patients will be nebulised with fluticasone 500 mcg diluted to 5ml and Group S will be nebulised with 5ml Normal saline. Post operative sore throat, cough grade, pain score and hoarseness of voice will be assessed at postoperative period of 0,2,4,8,12 and 24 hours. Data thus collected will be statistically analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patient of age group 18 to 70 years.
- •American Society of Anaesthesiology (ASA) physical status (PS) 1,2,
- •BMI less than 35kg/m
- •Scheduled to undergo elective surgery lasting more than 2 hours, under General Anaesthesia (GA) using Endotracheal Tube (ETT).
排除标准
- •Patients who are uncooperative and unwilling to take part in study -Patient with history of preoperative sore throat or upper respiratory tract infection.
- •Known allergy to budesonide or fluticasone.
- •Patient already on budesonide or fluticasone treatment -Pregnant or lactating mothers -History of COPD or Asthma -Mallampati grade greater than 2 -Surgeries in prone position.
- •Patients undergoing day care, bariatric, cardiac, nasal, oral, head and neck surgeries.
- •Patient requiring throat pack -Obese patients BMI greater than 35kg/m
- •Patients with history of use of steroids or NSAIDS within 24 hrs of surgery -Patients having psychiaric illness and communication difficulties.
结局指标
主要结局
To compare incidence, severity and duration of sore throat in all 3 groups
时间窗: To compare incidence, severity and duration of sore throat at post op hours 0, 2, 4, 8, 12, 24
次要结局
- 1. To compare occurance of postextubation cough and hoarseness of voice in all 3 groups(2. To compare side effect profile of both the drugs)
研究者
Tanveer Singh
Dayanand Medical College and Hospital, Ludhiana