Efficacy of Benzydamine Hydrochloride Dripping at Endotracheal Tube Cuff for Prevention of Postoperative Sore Throat
试验速览
- 阶段
- 3 期
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- analgesic effect
研究概览
简要总结
To evaluate the analgesic effect of benzydamine hydrochloride dripping on the endotracheal tube cuff for postoperative sore throat.
详细描述
The investigators will assign patients into either the benzydamine hydrochloride or the control group. The whole ETT cuff will be either dripped with 3 ml (4.5 mg) of benzydamine hydrochloride or nothing 5 minutes prior to anesthesia induction. The incidence and severity of POST at 0, 2, 4, 6, 12 and 24 hours postoperatively will be assessed. The potential adverse effects of benzydamine hydrochloride (throat numbness, throat burning sensation, dry mouth and thirst) will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 years
- •ASA status I-II
- •Mallampati grade I-II
- •Duration of surgery less than 4 hours
- •Patients placed in the supine position
排除标准
- •Undergoing oral, cervical spine or thyroid surgery
- •More than one attempt of ETT intubation or intubated with a technique of rapid sequence induction with cricoid pressure
- •Insertion of nasogastric/orogastric tube or esophageal stethoscope
- •Complaint of sore throat or hoarseness
- •Presence of upper respiratory tract infection within 7 days prior to the operation
- •Gastroesophageal reflux
- •Known allergy to benzydamine hydrochloride or other nonsteroidal anti-inflammatory drugs (NSAIDs)
研究组 & 干预措施
benzydamine HCl
benzydamine HCl will be dripped on the cuff of the endotracheal tube 5 minutes before induction of general anesthesia
干预措施: benzydamine HCl (Drug)
结局指标
主要结局
analgesic effect
时间窗: 24 hours
evaluate pain score for sore throat at 0, 2, 4, 6, 12 and 24 hours after the operation
次要结局
- side effects of benzydamine hydrochloride(24 hours)
研究者
Sasikaan Nimmaanrat
Associate Professor
Prince of Songkla University