Comparative evaluation of preoperative nebulisation with two doses of fluticasone for postoperative sore throat in patients undergoing general anaesthesia with endotracheal intubation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1. Incidence and Severity of Post Operative Sore Throat.
研究概览
简要总结
Different studies have shown that preoperativenebulization with budesonide in a dose of400mcg per day is effective for attenuating POST.However, there isonly one study where preoperative nebulisation with fluticasone in a dose of 500mcg was found to be efficacious inprevention of POST. As Fluticasone is twice as efficacious as Budesonide[14], we hypothesise that pre-operative nebulization with250mcg of Fluticasone will be equally effective in reducing the incidence andseverity of POST. In this study we aim to compare the efficacy ofpre-operative nebulisation of 250mcg offluticasone with 500mcg fluticasone and normal saline in reduction ofincidence and severity of POST in adult patients following endotracheal intubation under generalanaesthesia. These doses are shown to be not associated withhypothalamo-pituitary-adrenal axis depression even iftaken for 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator 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
- •AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) PHYSICAL STATUS 1 AND 2 UNDERGOING LAPAROSCOPIC SURGERIES.
排除标准
- •Patient with anticipated difficult airway.
- •Patients with history of preoperative sore throat, oral surgeries, asthma, COPD, diabetes, head and neck surgeries.
- •3.Patients with known allergies to study drugs and rescue drugs.
- •Patients consuming NSAIDS and steroidal drugs.
- •Duration of surgery less than 1 or more than 4 hours.
结局指标
主要结局
1. Incidence and Severity of Post Operative Sore Throat.
时间窗: 0,2,6,12,24 hours after Extubation.
次要结局
- 1. Incidence and severity of cough.(2. Incidence and severity of hoarseness of voice.)