A clinical study of comparative evaluation of effect of benzydamine hydrochloride (0.15 percent) spray and lidocaine hydrochloride (10 percent) spray on endotracheal tube cuff on post-operative cough, sore throat and hoarseness of voice in patients undergoing general anaesthesia with endotracheal tube placement.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 432
- 试验地点
- 1
- 主要终点
- The incidence of postoperative sore throat, hoarseness of voice, and cough at predetermined postoperative time intervals(0,1,6,12,24 hours) after extubation, compared among patients receiving benzydamine hydrochloride (0.15%), lidocaine hydrochloride (10%), or normal saline spray applied to the endotracheal tube cuff.
研究概览
简要总结
This study is a randomized controlled study comparing the effectiveness of benzydamine hydrochloride (0.15%) spray, lidocaine hydrochloride (10%) spray, and normal saline spray when applioed to the endotracheal tube (ETT) cuff in reducing the incidence of postoperative cough, sore throat, and hoarseness of voice in patients undergoing general anaesthesia with endotracheal intubation. The primary objective is to compare the incidence of postoperative sore throat, hoarseness of voice, and cough among patients undergoing general anaesthesia following the application of either benzydamine hydrochloride, lidocaine hydrochloride, or normal saline spray on the endotracheal tube cuff. The secondary objective is to evaluate side effect (if any) of benzydamine hydrochloride and lidocaine hydrochloride.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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
- •Age 18 to 65 years
- •Patients of either gender
- •ASA physical status I-IV.
排除标准
- •Pre-existing airway disorders such as chronic cough, recurrent sore throat, or chronic respiratory conditions including asthma or chronic obstructive pulmonary disease (COPD).
- •Known allergy to study drugs.
- •Anticipated difficult airway.
- •Pregnant or lactating women.
结局指标
主要结局
The incidence of postoperative sore throat, hoarseness of voice, and cough at predetermined postoperative time intervals(0,1,6,12,24 hours) after extubation, compared among patients receiving benzydamine hydrochloride (0.15%), lidocaine hydrochloride (10%), or normal saline spray applied to the endotracheal tube cuff.
时间窗: 2 years
次要结局
- Evaluation of side effects (if any) associated with benzydamine hydrochloride (0.15%) and lidocaine hydrochloride (10%) sprays applied to the endotracheal tube cuff.(2 years)
研究者
Harshit Jindal
Subharti Medical College