Combined Effect of Intravenous Lidocaine and Dexamethasone on Postoperative Sore Throat, Cough and Hoarseness. A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Assessment of postoperative sore throat at rest and on swallowing.
研究概览
简要总结
Post operative sore throat (POST) following tracheal intubation is a common problem causing dissatisfaction and discomfort to the patients. Prophylactic use of both lidocaine and dexamethasone has been used independently for this purpose. However, there is no study assessing the synergistic analgesic effects of lidocaine and dexamethasone for POST. The purpose of this study is to compare the effect of lidocaine, dexamethasone and lidocaine dexamethasone combination on the incidence and severity of POST.
详细描述
Sore throat and hoarseness following tracheal intubation are common postoperative problems causing dissatisfaction and discomfort to the patients. Their incidence varies from 30%-70%.
Both non pharmacological and pharmacological measures have been tried to minimize the incidence and severity of POST with variable success rate. Prophylactic use lidocaine and steroids have been used independently for this purpose. Dexamethasone as an adjuvant to lidocaine has shown to improve the quality of analgesia. However, there is no study assessing the combine effects of lidocaine and dexamethasone for POST.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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 of American Society of Anesthesiologist(ASA) physical status 1 & 2 requiring general anesthesia with endotracheal intubation.
- •Duration of surgery more than 90 min
排除标准
- •Those with preexisting hoarseness or sorethroat
- •Vocal performer by occupation
- •Recent or recurrent respiratory tract infection
- •Risk factors for postoperative aspiration
- •Pregnancy
- •Receiving analgesics, corticosteroids and calcium channel blockers
- •Contraindication to corticosteroid medications
- •Anticipated difficult intubation
- •Mallampati grade > 2
- •Difficult mask ventilation requiring oral or nasal airway
- •Cormack and Lehman grade III and IV on laryngoscopy
- •More than one intubation attempt
- •Those requiring orogastric or nasogastric tubes
结局指标
主要结局
Assessment of postoperative sore throat at rest and on swallowing.
时间窗: From 1 to 24 hr following surgery
Incidence of postoperative sore throat. Assessment of severity of postoperative sorethroat using scoring system, 0-No sore throat at any time since the operation,1- Minimal sore throat,2- Moderate sore throat,3- Severe sore throat
次要结局
- -Assessment of post operative cough. Assessment of post operative cough using scoring system,0- No cough,1- Minimal cough,2- Moderate cough,3- Severe cough.(From 1 to 24 hr following surgery)
研究者
Dr Asish Subedi
Associate Professor, Department of Anesthesiology, BPKIHS
B.P. Koirala Institute of Health Sciences