Effect of Preoperative dexamethasone nebulization for attenuation of postoperative sore throat, hoarseness of voice and cough in general anaesthesia: A randomized controlled double blinded study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess the incidence and severity of-
研究概览
简要总结
Sore throat, hoarseness of voice and cough are common postoperative complications following endotracheal intubation, and are more commonly found in the pediatric population. These problems, although self limiting, lead to patient’s discomfort.
Postoperative sore throat along with hoarseness of voice and cough contributes to postoperative morbidity and patient dissatisfaction. Post-operative sore throat has been rated by patients as the eighth most adverse effect in the postoperative period.
Dexamethasone is a corticosteroid which has been used here owing to its anti-inflammatory and membrane-stabilizing action. Its onset for action is 1 hour after administration. It is used in the treatment of many inflammatory and auto-immune diseases such as rheumatoid arthritis, severe allergies, asthma, chronic obstructive lung disease and ocular pains due to ophthalmic surgeries.
It has been used for nebulization for attenuation of postoperative sore throat due to its anti inflammatory action.
It will be used in our study in the dose of 0.16 mg/kg with the total volume made up to 5ml using saline for prevention of postoperative sore throat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 6.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between 6-14 years of either sex Undergoing surgeries under general anaesthesia in supine position Duration of surgery up to 2 hours ASA physical status – I,II.
排除标准
- •Age < 6and >14 years ASA physical status III and above Mallampati grade > 2 Any psychiatric disorder or history of epilepsy Neurosurgical patients with raised intracranial pressure Patients with cardiac anomalies Patients sensitive or allergic to study drug History of pre-operative sore throat, oral surgeries, asthma, chronic obstructive pulmonary disease, head and neck surgeries.
- •Recent non-steroidal drug medication Anticipated difficult intubation Patient and/or his/her legally acceptable representative not willing to provide their voluntary written informed consent for participation in the study.
结局指标
主要结局
To assess the incidence and severity of-
时间窗: 0hr,2hr,4hr,6hr,12hr,24hr
Postoperative sore throat (POST)
时间窗: 0hr,2hr,4hr,6hr,12hr,24hr
Postoperative Hoarseness of voice
时间窗: 0hr,2hr,4hr,6hr,12hr,24hr
Post-operative Cough
时间窗: 0hr,2hr,4hr,6hr,12hr,24hr
次要结局
- Haemodynamic parameters (HR, SBP, DBP, MAP & SpO2)(Side effects, if any)